Efficacy and Safety of Armodafinil for Adults With Excessive Sleepiness Obstructive Sleep Apnea/Hypopnea and Depression

Sponsor

Cephalon (Industry)

Overall Status

Completed

CT.gov ID

NCT00518986

Collaborator

(none)

249

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of the study is to evaluate whether armodafinil at a target dosage of 200 mg/day is more effective than placebo treatment in improving excessive sleepiness in patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) who have comorbid major depressive disorder or dysthymic disorder.

Condition or Disease	Intervention/Treatment	Phase
Sleep Disorders Obstructive Sleep Apnea Major Depressive Disorder Dysthymic Disorder	Drug: armodafinil Drug: placebo	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

249 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Armodafinil for Adults With Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome With Major Depressive Disorder or Dysthymic Disorder

Study Start Date :

Oct 1, 2007

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 armodafinil 200 mg/day	Drug: armodafinil 200 mg/day
Placebo Comparator: 2 Placebo	Drug: placebo placebo

Arm

Intervention/Treatment

Active Comparator: 1

armodafinil 200 mg/day

Drug: armodafinil

200 mg/day

Placebo Comparator: 2

Placebo

Drug: placebo

placebo

Outcome Measures

Primary Outcome Measures

Change From Baseline on Maintenance of Wakefulness Test (MWT) to Endpoint (12 Weeks or Last Observation After Baseline) [Baseline and 12 weeks (or last observation after baseline)]
MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of 4 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occurred. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to Endpoint (12 weeks or last observation after baseline) in mean sleep latency averaged from the 4 intervals was measured. Poorest outcome was 0 minutes the best was 30 minutes.
Clinical Global Impression of Change (CGI-C) at Endpoint (12-weeks or Last Observation After Baseline) [12 weeks (or last observation after baseline)]
The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates improvement by 7 categories: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories of illness as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least "minimally improved" in CGI-C ratings (as related to sleepiness) were assessed.

Secondary Outcome Measures

Change From Baseline on the Epworth Sleepiness Scale (ESS) at Endpoint (12 Weeks or Last Measurement After Baseline) [Baseline and 12 weeks (or last observation after baseline)]
For this key secondary outcome the ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to Endpoint (12 weeks or last observation after baseline) are summarized.
Change From Baseline on Maintenance of Wakefulness Test (MWT) at 4 Weeks [baseline and 4 weeks]
MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of four 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occured. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to 4 weeks in mean sleep latency (measured in minutes)averaged from each of the four testing intervals was measured. The poorest outcome was 0 minutes the best was 30 minutes.
Change From Baseline on Maintenance of Wakefulness Test (MWT) at 8 Weeks [Baseline and 8 weeks following start of study drug administration]
MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of four 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occured. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to 8 weeks in mean sleep latency (measured in minutes)averaged from each of the four testing intervals was measured. The poorest outcome was 0 minutes the best was 30 minutes.
Change From Baseline on Maintenance of Wakefulness Test (MWT) at 12 Weeks [baseline and 12 weeks (or last observation after baseline)]
MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of four 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occured. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to 12 weeks in mean sleep latency (measured in minutes)averaged from each of the four testing intervals was measured. The poorest outcome was 0 minutes the best was 30 minutes.
Clinical Global Impression of Change (CGI-C) at 4 Weeks [4 weeks after beginning study drug treatment]
The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least "minimally improved" in CGI-C ratings (as related to sleepiness) at 4 weeks were assessed.
Clinical Global Impression of Change (CGI-C) at 8 Weeks [8 weeks after beginning study drug treatment]
The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least "minimally improved" in CGI-C ratings (as related to sleepiness) at 8 weeks were assessed.
Clinical Global Impression of Change (CGI-C) at 12 Weeks [12 weeks after beginning treatment]
The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least minimal improvement in CGI-C ratings (as related to sleepiness) were assessed.
Clinical Global Impression of Change (CGI C) at 4 Weeks - Full Scale [4 weeks after start of treatment]
The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. The results for the number of participants who responded to each item on the full scale at 4 weeks are presented.
Clinical Global Impression of Change (CGI-C) at 8 Weeks - Full Scale [8 weeks after start of study drug treatment]
The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. The results for the number of participants who responded to each item on the full scale at 8 weeks are presented.
Clinical Global Impression of Change (CGI-C) at 12 Weeks - Full Scale [12 weeks after starting study drug treatment]
The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. The results for the number of participants who responded to each item on the full scale at 12 weeks are presented.
Change From Baseline on Epworth Sleepiness Scale (ESS) at 2 Weeks [Baseline and 2 weeks following start of study drug administration]
ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to two weeks are summarized.
Change From Baseline on Epworth Sleepiness Scale (ESS) at 4 Weeks [Baseline and 4 weeks after start of study drug administration]
ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to 4 weeks are summarized.
Change From Baseline on Epworth Sleepiness Scale (ESS) at 8 Weeks [Baseline and 8 weeks after start of study drug administration]
ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to 8 weeks are summarized.
Change From Baseline on Epworth Sleepiness Scale (ESS) at 12 Weeks [12 weeks (or last observation after baseline)]
ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to 12 weeks are summarized.
Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 2 Weeks [2 weeks]
ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 2 weeks are presented.
Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 4 Weeks [4 weeks]
ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 4 weeks are presented.
Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 8 Weeks [8 weeks]
ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 8 weeks are presented.
Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 12 Weeks [12 weeks]
ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 12 weeks are presented.
Change From Baseline to Endpoint (Week 12 or Last Observation After Baseline) in the Brief Fatigue Inventory (BFI) Total Score [Baseline and 12 weeks following start of study drug administration or last recorded observation]
The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 12 weeks or last observation after baseline.
Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 2 Weeks [Baseline and 2 weeks after start of study drug administration]
The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 2 weeks.
Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 4 Weeks [Baseline and 4 weeks after start of study drug administration]
The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 4 weeks.
Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 8 Weeks [Baseline and 8 weeks after start of study drug administration]
The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 8 weeks.
Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 12 Weeks [Baseline and 12 weeks after start of study drug administration]
The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 12 weeks.
Change From Baseline on the Brief Fatigue Inventory (BFI) Worst Daily Fatigue Score at Endpoint (12 Weeks or Last Observation After Baseline) [Baseline and 12 weeks or last observation after baseline]
The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with >= 7 indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 12 (or last observation after baseline).
Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 2 Weeks [Baseline and 2 weeks after start of study drug administration]
The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 2.
Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 4 Weeks [Baseline and 4 weeks after start of study drug administration]
The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 4.
Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 8 Weeks [Baseline and 8 weeks after start of study drug administration]
The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 8.
Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 12 Weeks [12 weeks]
The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 12.
Number of Responders According to Brief Fatigue Inventory (BFI) Worst Fatigue Score at Endpoint (12 Weeks or Last Observation After Baseline) [12 weeks after start of study drug administration (or last observation after baseline)]
The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 12 or last observation after baseline.
Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 2 Weeks [2 weeks after start of study drug administration]
The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 2.
Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 4 Weeks [4 weeks after start of study drug administration]
The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 4.
Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 8 Weeks [8 weeks after start of study drug administration]
The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 8.
Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 12 Weeks [12 weeks after start of study drug administration]
The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 12.
Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at Endpoint (12 Weeks or Last Observation After Baseline) [Baseline and at endpoint (12 weeks or last observation after baseline)]
The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.
Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 2 Weeks [Baseline and 2 weeks after start of study drug administration]
The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.
Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 4 Weeks [Baseline and 4 weeks after start of study drug administration]
The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.
Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 8 Weeks [Baseline and 8 weeks after start of study drug administration]
The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.
Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 12 Weeks (or Last Observation After Baseline) [Baseline and 12 weeks after start of study drug administration]
The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.
Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at Endpoint (12 Weeks or Last Observation After Baseline) [Baseline and endpoint (12 weeks after start of study drug or last observation after baseline)]
The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum of 2 maximum of 120) was calculated from the responses. The change in total score from baseline to Endpoint (12 weeks or last observation after baseline) is presented here.
Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 2 Weeks [baseline and 2 weeks following start of study drug administration]
The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 2 weeks is presented here.
Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 4 Weeks [baseline and 4 weeks following start of study drug administration]
The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 4 weeks is presented here.
Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 8 Weeks [baseline and 8 weeks following start of study drug administration]
The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 8 weeks is presented here.
Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 12 Weeks [baseline and 12 weeks following the start of study drug administration]
The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 12 weeks is presented here.
Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at Endpoint (Week 12 or Last Observation After Baseline) [Endpoint (week 12 or last observation after baseline)]
The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at Endpoint (12 weeks or last observation after baseline) is presented.
Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 2 Weeks [2 weeks following start of study drug administration]
The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum=2 maximum=120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at 2 weeks is presented here.
Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 4 [4 weeks following start of study drug administration]
The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum=2 maximum = 120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at 4 weeks is presented here.
Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 8 [8 weeks following start of study drug administration]
The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score was calculated from the responses (minimum = 2 maximum = 120). A responder analysis defining responders as patients with a total score > 17.9 at 8 weeks is presented here.
Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 12 [12 weeks following the start of study drug administration]
The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at 12 weeks is presented here.
Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at Endpoint (12 Weeks or Last Observation After Baseline) [Baseline and Endpoint (12 weeks or last observation after baseline)]
The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning:confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. Responses range from "none of the time" to "all of the time". The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to Endpoint (12 weeks or last observation after baseline).
Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 2 Weeks [baseline and 2 weeks]
The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from "none of the time" to "all of the time". The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 2 weeks.
Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 4 Weeks [baseline and 4 weeks following start of study drug administration]
The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from "none of the time" to "all of the time". The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 4 weeks.
Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 8 Weeks [baseline and 8 weeks following start of study drug administration]
The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from "none of the time" to "all of the time". The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 8 weeks.
Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 12 Weeks [baseline and 12 weeks following start of study drug administration]
The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from "none of the time" to "all of the time". The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 12 weeks.
Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at Endpoint (12 Weeks or Last Observation After Baseline) [Baseline and Endpoint (12 weeks or last observation after baseline)]
The Excessive Sleepiness Symptom Rating Form was used to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(tiredness, fatigue, sleepiness, lack of energy, trouble paying attention, forgetfulness, trouble staying organized) on an 11-point Likert scale (0 = no problem at all to 10 = as bad as you can imagine). ES Symptom Rating Form was designed to follow the response to treatment measuring severity of each of these 7 symptoms using the same 11-point scale. Change from Baseline to Endpoint (12 weeks or last baseline observation) is presented only for the symptom of "Sleepiness".
Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 2 Weeks [Baseline and 2 weeks]
Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0="no problem at all" 10="as bad as you can imagine"). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 2 Weeks is presented only for the symptom of "Sleepiness".
Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 4 Weeks [Baseline and 4 weeks following start of study drug administration]
Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0="no problem at all" 10="as bad as you can imagine"). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 4 Weeks is presented only for the symptom of "Sleepiness".
Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 8 Weeks [baseline and 8 weeks following start of study drug administration]
Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0="no problem at all" 10="as bad as you can imagine"). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 8 Weeks is presented only for the symptom of "Sleepiness".
Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 12 Weeks [Baseline and 12 weeks following start of study drug administration]
Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0="no problem at all" 10="as bad as you can imagine"). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 12 Weeks is presented only for the symptom of "Sleepiness".

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Current diagnosis of obstructive sleep apnea/hypopnea syndrome (OSAHS)
Complaint of residual excessive sleepiness despite nasal continuous positive airway pressure (nCPAP) therapy being effective
Current or prior diagnosis of major depressive disorder or dysthymic disorder
Clinically stable with regard to depressed mood and has shown a treatment response to selective serotonin reuptake inhibitor (SSRI) therapy or serotonin and norepinephrine reuptake inhibitor (SNRI) therapy
Patient has been on a stable monotherapy dose of an allowed SSRI or SNRI for at least 8 weeks at the time of screening
Women of childbearing potential must use a medically accepted method of contraception.

Exclusion Criteria:

Confirmed or suspected diagnosis of a currently active sleep disorder other than obstructive sleep apnea/hypopnea syndrome (OSAHS)
Current episode of major depression that is considered to be treatment-resistant
A primary diagnosis of: eating disorder, psychotic disorder, delirium, dementia, substance-related disorders, or moderate to severe hypochondriasis
Patient has a history of bipolar disorder, psychotic depression, schizophrenia, schizoaffective disorder, any other psychotic disorder, or other clinically significant uncontrolled psychiatric condition.
Patient has a history of homicidal ideation or significant aggression
Patient has a diagnosis of severe antisocial or borderline personality disorder
Has a history of significant suicidal ideation, or has current active suicidal ideation, or is considered at imminent risk of self harm.
Patient has a history consistent with fibromyalgia or chronic fatigue syndrome
A high consumption of caffeinated products, approximately equivalent to 5 or more cups of coffee per day
Patient history of any clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction
Has a past or present seizure disorder
Patient has a history of alcohol, narcotic, or any other substance abuse or dependence (with the exception of nicotine)
Psychotherapeutic intervention for the patient was initiated within 8 weeks of the screening visit.
Patient has known human immunodeficiency virus (HIV)
Patient has any clinically significant uncontrolled medical condition (including illnesses related to the cardiovascular, renal, or hepatic systems) or surgical condition (treated or untreated)
Patient is a pregnant or lactating woman
Patient has previously received armodafinil; or, patient has used modafinil or any investigational product within 28 days of the baseline visit.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jasper Summit Research, LLC	Jasper	Alabama	United States	35501
2	Pulmonary Associates, P.A.	Phoenix	Arizona	United States	85012
3	Psypharma Clinical Research	Phoenix	Arizona	United States	85050
4	PsyPharm Clinical Research, Inc.	Tucson	Arizona	United States	85712
5	Behavioral Research Specialists	Glendale	California	United States	91204
6	California Clinical Trials Medical Group, Inc.	Glendale	California	United States	91206
7	Pacific Sleep Medicine Services, Inc.	Redlands	California	United States	92373
8	Pacific Research Network, Inc.	San Diego	California	United States	92103
9	Pacific Sleep Medicine Services, Inc.	San Diego	California	United States	92121
10	California Clinical Trials Medical Group, Inc.	San Diego	California	United States	92123
11	SDS Clinical Research	Santa Ana	California	United States	92704
12	St. Johns Medical Plaza Sleep Disorders Center	Santa Monica	California	United States	90404
13	National Jewish Medical and Research Center	Denver	Colorado	United States	80206
14	Rocky Mountain Center for Clinical Research	Wheat Ridge	Colorado	United States	80033
15	PAB Clinical Research	Brandon	Florida	United States	33511
16	Florida Sleep Institute	Spring Hill	Florida	United States	34609
17	Clinical Research Group of St. Petersburg	St. Petersburg	Florida	United States	33707
18	SomnoMedics	Tampa	Florida	United States	33607
19	Stedman Clinical Trials, LLC	Tampa	Florida	United States	33613
20	Florida Pulmonary Research Center, LLC	Winter Park	Florida	United States	33613
21	The Sleep Disorders Center	Atlanta	Georgia	United States	30339
22	Neurotrials Research, Inc	Atlanta	Georgia	United States	30342
23	Sleep Disorders Center of Georgia	Atlanta	Georgia	United States	30342
24	SleepMed, Inc	Macon	Georgia	United States	31201
25	Chicago Research Center	Chicago	Illinois	United States	60634
26	Peoria Pulmonary Associates	Peoria	Illinois	United States	61603
27	Sleep and Behavior Medicine	Vernon Hills	Illinois	United States	60061
28	The Center for Sleep and Wake Disorders	Danville	Indiana	United States	46122
29	Vince & Associates Clinical Research	Overland Park	Kansas	United States	66212
30	Graves Gilbert Clinic	Bowling Green	Kentucky	United States	42101
31	Community Research	Crestview	Kentucky	United States	45217
32	Clinical Trials of America	Shreveport	Louisiana	United States	71101
33	The Center for Sleep & Wake Disorders	Chevy Chase	Maryland	United States	20815
34	Sleep Health Centers	Brighton	Massachusetts	United States	02135
35	AccelRx Research	Fall River	Massachusetts	United States	02721
36	The Center for Sleep Medicine	Hattiesburg	Mississippi	United States	39406
37	Washington University	St. Louis	Missouri	United States	63108
38	Somnos Sleep Center	Lincoln	Nebraska	United States	68510
39	Brooklyn Medical Institute	Brooklyn	New York	United States	11223
40	Clinilabs, Inc	New York City	New York	United States	10019
41	Sleep Medicine Centers	West Seneca	New York	United States	14224
42	Duke University Medical Center	Durham	North Carolina	United States	27710
43	Clinical Trials of America	Hickory	North Carolina	United States	28601
44	Tri-State Sleep Disorders Center	Cincinnati	Ohio	United States	45246
45	Ohio Sleep Medicine Institute	Dublin	Ohio	United States	43017
46	North Star Medical Research, LLC	Middleburg Heights	Ohio	United States	44130
47	St. Vincent Mercy Medical Center	Toledo	Ohio	United States	43606
48	Lynn Health Science Institute	Oklahoma City	Oklahoma	United States	73112
49	Sleep Lab of Northeastern PA	Clarks Summit	Pennsylvania	United States	18411
50	University of Pennsylvania Center for Sleep	Philadelphia	Pennsylvania	United States	19104
51	CRI Worldwide	Philadelphia	Pennsylvania	United States	19139
52	University Services	West Chester	Pennsylvania	United States	19380
53	AccelRx Research	Lincoln	Rhode Island	United States	02865
54	Lowcountry Lung and Critical Care	Charleston	South Carolina	United States	29406
55	SleepMed of South Carolina	Columbia	South Carolina	United States	29201
56	Sleep Medicine of Middle Tennessee	Nashville	Tennessee	United States	37203
57	FutureSearch Trials of Neurology	Austin	Texas	United States	78756
58	Sleep Medicine Associates of Texas, P.A.	Dallas	Texas	United States	75231
59	Baylor College of Medicine VAMC Sleep Research	Houston	Texas	United States	77030
60	Houston Sleep Center	Houston	Texas	United States	77063
61	Northwest Clinical Research	Bellevue	Washington	United States	98004
62	Pacific Sleep Medicine Services, Inc.	Seattle	Washington	United States	98122

Sponsors and Collaborators

Cephalon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cephalon

ClinicalTrials.gov Identifier:

NCT00518986

Other Study ID Numbers:

C10953/4024/ES/US

First Posted:

Aug 21, 2007

Last Update Posted:

Jul 19, 2013

Last Verified:

Jul 1, 2013

Keywords provided by Cephalon

Obstructive Sleep Apnea/Hypopnea Syndrome

Excessive Sleepiness

Additional relevant MeSH terms:

Apnea

Sleep Apnea Syndromes

Sleep Apnea, Obstructive

Depressive Disorder, Major

Dysthymic Disorder

Modafinil

Study Results

Participant Flow

Recruitment Details	55 centers in the US. First participant enrolled: October 2007/ Last participant last visit: March 2009
Pre-assignment Detail	The study consisted of a 1-week single-blind, placebo run-in screening period followed by a 12-week double blind treatment period. Of the 249 patients enrolled, 248 patients received at least 1 dose of study drug and were evaluated for safety; 1 patient who was assigned to receive armodafinil was lost to follow-up before taking any study drug.

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Period Title: Overall Study
STARTED	125	124
COMPLETED	99	98
NOT COMPLETED	26	26

Baseline Characteristics

Arm/Group Title	Armodafinil 200 mg/Day	Placebo	Total
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.	Total of all reporting groups
Overall Participants	125	124	249
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	125 100%	124 100%	249 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.5 (10.32)	49.5 (9.69)	49.5 (9.99)
Sex: Female, Male (Count of Participants)
Female	68 54.4%	66 53.2%	134 53.8%
Male	57 45.6%	58 46.8%	115 46.2%
Region of Enrollment (participants) [Number]
United States	125 100%	124 100%	249 100%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline on Maintenance of Wakefulness Test (MWT) to Endpoint (12 Weeks or Last Observation After Baseline)
Description	MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of 4 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occurred. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to Endpoint (12 weeks or last observation after baseline) in mean sleep latency averaged from the 4 intervals was measured. Poorest outcome was 0 minutes the best was 30 minutes.
Time Frame	Baseline and 12 weeks (or last observation after baseline)

Outcome Measure Data

Analysis Population Description
Full analysis set which includes subjects who had at least 1 measurement of MWT or Clinical Global Impression of Change (CGI-C) after baseline.

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	109	105
Mean (Standard Deviation) [Minutes]	2.6 (7.09)	1.1 (7.61)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Since there were two primary outcome measures the Hochberg procedure was used to control overall Type 1 error rate at the 0.05 level. If both p-values for the primary variables were <= 0.05 the treatment was claimed to be significant for both variables. If 1 p-value was > 0.05and the other was <=0.025, the variable with a p-value <= 0.025 was claimed as significant.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.3043
	Comments
	Method	ANCOVA
	Comments	Study drug was fixed factor and corresponding baseline value was a covariate.

2. Primary Outcome

Title	Clinical Global Impression of Change (CGI-C) at Endpoint (12-weeks or Last Observation After Baseline)
Description	The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates improvement by 7 categories: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories of illness as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least "minimally improved" in CGI-C ratings (as related to sleepiness) were assessed.
Time Frame	12 weeks (or last observation after baseline)

Outcome Measure Data

Analysis Population Description
Full analysis set which includes subjects who had at least 1 measurement of MWT or CGI-C after baseline.

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	113	112
At least minimal improvement	78 62.4%	59 47.6%
No improvement	35 28%	53 42.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Since there were two primary outcome measures the Hochberg procedure was used to control overall Type 1 error rate at the 0.05 level. If both p-values for the primary variables were <= 0.05 the treatment was claimed to be significant for both variables. If 1 p-value was > 0.05and the other was <=0.025, the variable with a p-value <= 0.025 was claimed as significant.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0120
	Comments
	Method	Chi-squared
	Comments	P-value for comparison is from a Pearson's chi-square test

3. Secondary Outcome

Title	Change From Baseline on the Epworth Sleepiness Scale (ESS) at Endpoint (12 Weeks or Last Measurement After Baseline)
Description	For this key secondary outcome the ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to Endpoint (12 weeks or last observation after baseline) are summarized.
Time Frame	Baseline and 12 weeks (or last observation after baseline)

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who had at least one assessment of ESS after baseline

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	113	112
Least Squares Mean (Standard Error) [Units on a scale]	-6.5 (0.44)	-4.6 (0.44)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Least squares (LS) mean and standard error of the LS mean for each treatment group, and p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline as covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0027
	Comments	Nominal p-value is presented, but statistical significance cannot be claimed. As a key secondary variable significance could be claimed only if treatment effect was significant for both primary efficacy variables.
	Method	ANCOVA
	Comments

4. Secondary Outcome

Title	Change From Baseline on Maintenance of Wakefulness Test (MWT) at 4 Weeks
Description	MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of four 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occured. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to 4 weeks in mean sleep latency (measured in minutes)averaged from each of the four testing intervals was measured. The poorest outcome was 0 minutes the best was 30 minutes.
Time Frame	baseline and 4 weeks

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who had MWT measurement at baseline and at 4 weeks

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	108	105
Least Squares Mean (Standard Error) [Minutes]	2.7 (0.63)	-0.1 (0.64)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0019
	Comments
	Method	ANCOVA
	Comments

5. Secondary Outcome

Title	Change From Baseline on Maintenance of Wakefulness Test (MWT) at 8 Weeks
Description	MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of four 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occured. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to 8 weeks in mean sleep latency (measured in minutes)averaged from each of the four testing intervals was measured. The poorest outcome was 0 minutes the best was 30 minutes.
Time Frame	Baseline and 8 weeks following start of study drug administration

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects with MWT measure at 8 weeks and baseline

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	104	100
Least Squares Mean (Standard Error) [Minutes]	2.1 (0.61)	1.2 (0.62)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.3145
	Comments
	Method	ANCOVA
	Comments

6. Secondary Outcome

Title	Change From Baseline on Maintenance of Wakefulness Test (MWT) at 12 Weeks
Description	MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of four 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occured. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to 12 weeks in mean sleep latency (measured in minutes)averaged from each of the four testing intervals was measured. The poorest outcome was 0 minutes the best was 30 minutes.
Time Frame	baseline and 12 weeks (or last observation after baseline)

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who had measurements of MWT at baseline and 12 weeks.

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	96	95
Least Squares Mean (Standard Error) [Minutes]	2.5 (0.64)	1.4 (0.64)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.2196
	Comments
	Method	ANCOVA
	Comments

7. Secondary Outcome

Title	Clinical Global Impression of Change (CGI-C) at 4 Weeks
Description	The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least "minimally improved" in CGI-C ratings (as related to sleepiness) at 4 weeks were assessed.
Time Frame	4 weeks after beginning study drug treatment

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who were assessed with CGI-C at 4 weeks

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	111	108
At least minimal improvement	75 60%	64 51.6%
No improvement	36 28.8%	44 35.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.2017
	Comments	P-value is from Pearson's chi-square test
	Method	Chi-squared
	Comments

8. Secondary Outcome

Title	Clinical Global Impression of Change (CGI-C) at 8 Weeks
Description	The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least "minimally improved" in CGI-C ratings (as related to sleepiness) at 8 weeks were assessed.
Time Frame	8 weeks after beginning study drug treatment

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects assessed by CGI-C at 8 weeks

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	104	98
At least minimal improvement	76 60.8%	52 41.9%
No improvement	28 22.4%	46 37.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0032
	Comments	P-value from Pearson's chi-square test
	Method	Chi-squared
	Comments

9. Secondary Outcome

Title	Clinical Global Impression of Change (CGI-C) at 12 Weeks
Description	The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least minimal improvement in CGI-C ratings (as related to sleepiness) were assessed.
Time Frame	12 weeks after beginning treatment

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects assessed with CGI-C at week 12

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	96	95
At least minimal improvement	69 55.2%	53 42.7%
No improvement	27 21.6%	42 33.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0207
	Comments	P-value from Pearson's chi-square test
	Method	Chi-squared
	Comments

10. Secondary Outcome

Title	Clinical Global Impression of Change (CGI C) at 4 Weeks - Full Scale
Description	The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. The results for the number of participants who responded to each item on the full scale at 4 weeks are presented.
Time Frame	4 weeks after start of treatment

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who were assessed by CGI-C at 4 weeks.

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	111	108
Very much improved	15 12%	11 8.9%
Much improved	34 27.2%	21 16.9%
Minimally improved	26 20.8%	32 25.8%
No change	32 25.6%	37 29.8%
Minimally worse	3 2.4%	5 4%
Much worse	1 0.8%	2 1.6%
Very much worse	0 0%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0529
	Comments	P-value was generated from a Cochran-Mantel-Haenszel chi-square test.
	Method	Cochran-Mantel-Haenszel
	Comments

11. Secondary Outcome

Title	Clinical Global Impression of Change (CGI-C) at 8 Weeks - Full Scale
Description	The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. The results for the number of participants who responded to each item on the full scale at 8 weeks are presented.
Time Frame	8 weeks after start of study drug treatment

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who were assessed by CGI-C at 8 weeks

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	104	98
Very much improved	16 12.8%	11 8.9%
Much improved	39 31.2%	19 15.3%
Minimally improved	21 16.8%	22 17.7%
No change	26 20.8%	37 29.8%
Minimally worse	1 0.8%	7 5.6%
Much worse	1 0.8%	2 1.6%
Very much worse	0 0%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0011
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

12. Secondary Outcome

Title	Clinical Global Impression of Change (CGI-C) at 12 Weeks - Full Scale
Description	The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. The results for the number of participants who responded to each item on the full scale at 12 weeks are presented.
Time Frame	12 weeks after starting study drug treatment

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects assessed by CGI-C at 12 weeks

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	96	95
Very much improved	27 21.6%	11 8.9%
Much improved	20 16%	22 17.7%
Minimally improved	22 17.6%	20 16.1%
No change	22 17.6%	34 27.4%
Minimally worse	4 3.2%	7 5.6%
Much worse	1 0.8%	1 0.8%
Very much worse	0 0%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0064
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

13. Secondary Outcome

Title	Change From Baseline on Epworth Sleepiness Scale (ESS) at 2 Weeks
Description	ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to two weeks are summarized.
Time Frame	Baseline and 2 weeks following start of study drug administration

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who completed the ESS at baseline and at 2 weeks

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	107	104
Least Squares Mean (Standard Error) [Unit on a scale]	-4.8 (0.40)	-3.8 (0.40)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1072
	Comments
	Method	ANCOVA
	Comments

14. Secondary Outcome

Title	Change From Baseline on Epworth Sleepiness Scale (ESS) at 4 Weeks
Description	ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to 4 weeks are summarized.
Time Frame	Baseline and 4 weeks after start of study drug administration

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who completed ESS at baseline and at Week 4

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	111	108
Least Squares Mean (Standard Error) [Units on a scale]	-5.5 (0.42)	-4.2 (0.43)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0355
	Comments
	Method	ANCOVA
	Comments

15. Secondary Outcome

Title	Change From Baseline on Epworth Sleepiness Scale (ESS) at 8 Weeks
Description	ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to 8 weeks are summarized.
Time Frame	Baseline and 8 weeks after start of study drug administration

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who completed ESS at Baseline and at 8 weeks

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	103	98
Least Squares Mean (Standard Error) [Units on a scale]	-6.0 (0.44)	-4.8 (0.45)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0591
	Comments
	Method	ANCOVA
	Comments

16. Secondary Outcome

Title	Change From Baseline on Epworth Sleepiness Scale (ESS) at 12 Weeks
Description	ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to 12 weeks are summarized.
Time Frame	12 weeks (or last observation after baseline)

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who completed ESS at Baseline and at 12 weeks

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	96	95
Least Squares Mean (Standard Error) [Units on a scale]	-6.8 (0.48)	-4.8 (0.48)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0025
	Comments
	Method	ANCOVA
	Comments

17. Secondary Outcome

Title	Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 2 Weeks
Description	ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 2 weeks are presented.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description
Full analysis set defined as the number of subjects who completed the ESS at 2 weeks

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	107	104
Responders	54 43.2%	40 32.3%
Non-responders	53 42.4%	64 51.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0794
	Comments	P-value for treatment comparison is from Pearson's chi-square test
	Method	Chi-squared
	Comments

18. Secondary Outcome

Title	Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 4 Weeks
Description	ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 4 weeks are presented.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description
Full analysis set defined as number of subjects who completed ESS at 4 weeks

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	111	108
Responders	59 47.2%	45 36.3%
Non-responders	52 41.6%	63 50.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0888
	Comments	P-value for the treatment comparison is from a Pearson's chi-square test
	Method	Chi-squared
	Comments

19. Secondary Outcome

Title	Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 8 Weeks
Description	ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 8 weeks are presented.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who completed ESS at 8 weeks

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	103	98
Responders	64 51.2%	47 37.9%
Non-responders	39 31.2%	51 41.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0433
	Comments	P-value for the treatment comparison is from a Pearson's chi-square test.
	Method	Chi-squared
	Comments

20. Secondary Outcome

Title	Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 12 Weeks
Description	ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 12 weeks are presented.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who completed the ESS at 12 weeks

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	96	95
Responders	65 52%	47 37.9%
Non-responders	31 24.8%	48 38.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0105
	Comments	P-value for the treatment comparison is from a Pearson's chi-square test.
	Method	Chi-squared
	Comments

21. Secondary Outcome

Title	Change From Baseline to Endpoint (Week 12 or Last Observation After Baseline) in the Brief Fatigue Inventory (BFI) Total Score
Description	The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 12 weeks or last observation after baseline.
Time Frame	Baseline and 12 weeks following start of study drug administration or last recorded observation

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects with at least one BFI assessment after baseline

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	112	110
Least Squares Mean (Standard Error) [Units on a scale]	-8.9 (1.82)	-3.8 (1.84)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0523
	Comments
	Method	ANCOVA
	Comments

22. Secondary Outcome

Title	Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 2 Weeks
Description	The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 2 weeks.
Time Frame	Baseline and 2 weeks after start of study drug administration

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who had completed BFI at baseline and at 2 weeks

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	110	106
Least Squares Mean (Standard Error) [Units on a scale]	-6.1 (1.67)	-0.9 (1.70)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0289
	Comments
	Method	ANCOVA
	Comments

23. Secondary Outcome

Title	Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 4 Weeks
Description	The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 4 weeks.
Time Frame	Baseline and 4 weeks after start of study drug administration

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who had completed BFI at baseline and at 4 weeks

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	111	107
Least Squares Mean (Standard Error) [Units on a scale]	-9.5 (1.72)	-5.8 (1.75)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1272
	Comments
	Method	ANCOVA
	Comments

24. Secondary Outcome

Title	Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 8 Weeks
Description	The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 8 weeks.
Time Frame	Baseline and 8 weeks after start of study drug administration

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	104	97
Least Squares Mean (Standard Error) [Units on a scale]	-8.8 (1.90)	-3.0 (1.97)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0349
	Comments
	Method	ANCOVA
	Comments

25. Secondary Outcome

Title	Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 12 Weeks
Description	The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 12 weeks.
Time Frame	Baseline and 12 weeks after start of study drug administration

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	95	94
Least Squares Mean (Standard Error) [Units on a scale]	-10.5 (1.92)	-3.3 (1.93)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0094
	Comments
	Method	ANCOVA
	Comments

26. Secondary Outcome

Title	Change From Baseline on the Brief Fatigue Inventory (BFI) Worst Daily Fatigue Score at Endpoint (12 Weeks or Last Observation After Baseline)
Description	The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with >= 7 indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 12 (or last observation after baseline).
Time Frame	Baseline and 12 weeks or last observation after baseline

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects with at least one observation after baseline

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	112	110
Least Squares Mean (Standard Error) [Units on a scale]	-1.3 (0.24)	-0.7 (0.24)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0754
	Comments
	Method	ANCOVA
	Comments

27. Secondary Outcome

Title	Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 2 Weeks
Description	The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 2.
Time Frame	Baseline and 2 weeks after start of study drug administration

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who completed BFI at baseline and at 2 weeks

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	110	107
Least Squares Mean (Standard Error) [Units on a scale]	-1.1 (0.23)	-0.2 (0.24)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0105
	Comments
	Method	ANCOVA
	Comments

28. Secondary Outcome

Title	Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 4 Weeks
Description	The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 4.
Time Frame	Baseline and 4 weeks after start of study drug administration

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who completed BFI at baseline and at 4 weeks

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	111	107
Least Squares Mean (Standard Error) [Units on a scale]	-1.2 (0.23)	-0.8 (0.24)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.2888
	Comments
	Method	ANCOVA
	Comments

29. Secondary Outcome

Title	Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 8 Weeks
Description	The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 8.
Time Frame	Baseline and 8 weeks after start of study drug administration

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who completed the BFI at baseline and at week 8

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	104	97
Least Squares Mean (Standard Error) [Units on a scale]	-1.2 (0.24)	-0.3 (0.25)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0130
	Comments
	Method	ANCOVA
	Comments

30. Secondary Outcome

Title	Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 12 Weeks
Description	The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 12.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	96	94
Least Squares Mean (Standard Error) [Units on a scale]	-1.4 (0.26)	-0.6 (0.26)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0354
	Comments
	Method	ANCOVA
	Comments

31. Secondary Outcome

Title	Number of Responders According to Brief Fatigue Inventory (BFI) Worst Fatigue Score at Endpoint (12 Weeks or Last Observation After Baseline)
Description	The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 12 or last observation after baseline.
Time Frame	12 weeks after start of study drug administration (or last observation after baseline)

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who had at least one observation after baseline

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	112	111
Responders	63 50.4%	56 45.2%
Non-responders	49 39.2%	55 44.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Responders are subjects with worst fatigue score < 7 after baseline
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.3854
	Comments	P-value for the treatment comparison is from a Pearson's chi-square test
	Method	Chi-squared
	Comments

32. Secondary Outcome

Title	Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 2 Weeks
Description	The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 2.
Time Frame	2 weeks after start of study drug administration

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who completed BFI at 2 weeks

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	110	108
Responders	62 49.6%	43 34.7%
Non-responders	48 38.4%	65 52.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Responders were defined as subjects with worst fatigue score < 7
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0145
	Comments	P-value for the treatment comparison is from Pearson's chi-square test
	Method	Chi-squared
	Comments

33. Secondary Outcome

Title	Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 4 Weeks
Description	The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 4.
Time Frame	4 weeks after start of study drug administration

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who completed BFI at 4 weeks

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	111	108
Responders	62 49.6%	57 46%
Non-responders	49 39.2%	51 41.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Responders were patients with worst fatigue scores < 7
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.6475
	Comments	P-value for the treatment comparison is from a Pearson's chi-square test
	Method	Chi-squared
	Comments

34. Secondary Outcome

Title	Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 8 Weeks
Description	The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 8.
Time Frame	8 weeks after start of study drug administration

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who completed the BFI at 8 weeks

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	104	98
Responders	63 50.4%	42 33.9%
Non-responders	41 32.8%	56 45.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Responders are subjects with worst fatigue score < 7
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0118
	Comments	P-value for the treatment comparison is from Pearson's chi-square test
	Method	Chi-squared
	Comments

35. Secondary Outcome

Title	Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 12 Weeks
Description	The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 12.
Time Frame	12 weeks after start of study drug administration

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who completed the BFI at 12 weeks

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	96	95
Responders	55 44%	48 38.7%
Non-responders	41 32.8%	47 37.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Responders are subjects with a worst fatigue score of < 7
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.3483
	Comments	P-value for the treatment comparison is from the Pearson's chi-square test.
	Method	Chi-squared
	Comments

36. Secondary Outcome

Title	Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at Endpoint (12 Weeks or Last Observation After Baseline)
Description	The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.
Time Frame	Baseline and at endpoint (12 weeks or last observation after baseline)

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who had at least one observation after baseline

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	112	110
Least Squares Mean (Standard Error) [Units on a scale]	-0.9 (0.22)	-0.3 (0.22)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0879
	Comments
	Method	ANCOVA
	Comments

37. Secondary Outcome

Title	Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 2 Weeks
Description	The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.
Time Frame	Baseline and 2 weeks after start of study drug administration

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who completed the BFI at baseline and at 2 weeks

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	110	107
Least Squares Mean (Standard Error) [Units on a scale]	-0.6 (0.20)	0.0 (0.20)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0277
	Comments
	Method	ANCOVA
	Comments

38. Secondary Outcome

Title	Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 4 Weeks
Description	The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.
Time Frame	Baseline and 4 weeks after start of study drug administration

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who completed the BFI at baseline and at 4 weeks

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	111	107
Least Squares Mean (Standard Error) [Units on a scale]	-1.0 (0.20)	-0.6 (0.20)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1245
	Comments
	Method	ANCOVA
	Comments

39. Secondary Outcome

Title	Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 8 Weeks
Description	The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.
Time Frame	Baseline and 8 weeks after start of study drug administration

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who completed the BFI at baseline and at 8 weeks

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	104	97
Least Squares Mean (Standard Error) [Units on a scale]	-0.9 (0.23)	-0.2 (0.23)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0305
	Comments
	Method	ANCOVA
	Comments

40. Secondary Outcome

Title	Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 12 Weeks (or Last Observation After Baseline)
Description	The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.
Time Frame	Baseline and 12 weeks after start of study drug administration

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who completed BFI at baseline and at 12 weeks

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	96	94
Least Squares Mean (Standard Error) [Units on a scale]	-1.1 (0.23)	-0.3 (0.23)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0129
	Comments
	Method	ANCOVA
	Comments

41. Secondary Outcome

Title	Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at Endpoint (12 Weeks or Last Observation After Baseline)
Description	The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum of 2 maximum of 120) was calculated from the responses. The change in total score from baseline to Endpoint (12 weeks or last observation after baseline) is presented here.
Time Frame	Baseline and endpoint (12 weeks after start of study drug or last observation after baseline)

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who had at least one observation after baseline

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	104	107
Least Squares Mean (Standard Error) [Units on a scale]	2.3 (0.26)	1.5 (0.26)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0308
	Comments
	Method	ANCOVA
	Comments

42. Secondary Outcome

Title	Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 2 Weeks
Description	The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 2 weeks is presented here.
Time Frame	baseline and 2 weeks following start of study drug administration

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who completed FOSQ at baseline and at 2 weeks

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	100	103
Least Squares Mean (Standard Error) [Units on a scale]	1.7 (0.24)	1.1 (0.24)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0679
	Comments
	Method	ANCOVA
	Comments

43. Secondary Outcome

Title	Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 4 Weeks
Description	The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 4 weeks is presented here.
Time Frame	baseline and 4 weeks following start of study drug administration

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who completed the FOSQ at baseline and at 4 weeks

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	101	103
Least Squares Mean (Standard Error) [Units on a scale]	2.2 (0.23)	1.4 (0.22)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0153
	Comments
	Method	ANCOVA
	Comments

44. Secondary Outcome

Title	Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 8 Weeks
Description	The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 8 weeks is presented here.
Time Frame	baseline and 8 weeks following start of study drug administration

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who completed the FOSQ at baseline and at 8 weeks

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	97	96
Least Squares Mean (Standard Error) [Units on a scale]	2.2 (0.25)	1.4 (0.25)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0296
	Comments
	Method	ANCOVA
	Comments

45. Secondary Outcome

Title	Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 12 Weeks
Description	The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 12 weeks is presented here.
Time Frame	baseline and 12 weeks following the start of study drug administration

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who completed the FOSQ at baseline and at 12 weeks

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	89	93
Least Squares Mean (Standard Error) [Units on a scale]	2.6 (0.27)	1.6 (0.27)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0107
	Comments
	Method	ANCOVA
	Comments

46. Secondary Outcome

Title	Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at Endpoint (Week 12 or Last Observation After Baseline)
Description	The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at Endpoint (12 weeks or last observation after baseline) is presented.
Time Frame	Endpoint (week 12 or last observation after baseline)

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects with at least one observation after baseline

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	110	108
Responders	49 39.2%	30 24.2%
Non-responders	61 48.8%	78 62.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Responders are defined as patients with a total score on FOSQ > 17.9
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0100
	Comments	P-value for the treatment comparison is from a Pearson's chi-square test
	Method	Chi-squared
	Comments

47. Secondary Outcome

Title	Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 2 Weeks
Description	The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum=2 maximum=120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at 2 weeks is presented here.
Time Frame	2 weeks following start of study drug administration

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subject who completed the FOSQ at 2 weeks

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	105	103
Responders	30 24%	19 15.3%
Non-responders	75 60%	84 67.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Responders are defined as subjects with a total score of > 17.9
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0854
	Comments	P-value for treatment comparison is from a Pearson's chi-square test
	Method	Chi-squared
	Comments

48. Secondary Outcome

Title	Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 4
Description	The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum=2 maximum = 120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at 4 weeks is presented here.
Time Frame	4 weeks following start of study drug administration

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who completed the FOSQ at 4 weeks

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	105	103
Responders	45 36%	24 19.4%
Non-responders	60 48%	79 63.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Responders are defined as subjects with a total score > 17.9
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0027
	Comments	P-value for the treatment comparison is from Pearson's chi-square test
	Method	Chi-squared
	Comments

49. Secondary Outcome

Title	Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 8
Description	The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score was calculated from the responses (minimum = 2 maximum = 120). A responder analysis defining responders as patients with a total score > 17.9 at 8 weeks is presented here.
Time Frame	8 weeks following start of study drug administration

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who completed the FOSQ at 8 weeks

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	101	97
Responders	36 28.8%	20 16.1%
Non-responders	65 52%	77 62.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Responders are defined as subjects who had a total score of > 17.9
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0189
	Comments	P-value for the treatment comparison is from a Pearson's chi-square test.
	Method	Chi-squared
	Comments

50. Secondary Outcome

Title	Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 12
Description	The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at 12 weeks is presented here.
Time Frame	12 weeks following the start of study drug administration

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who completed the FOSQ at 12 weeks

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	94	94
Responders	43 34.4%	28 22.6%
Non-responders	51 40.8%	66 53.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Responders are defined as subjects with total score > 17.9
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0240
	Comments	P-value for the treatment comparison is from a Pearson's chi-square test
	Method	Chi-squared
	Comments

51. Secondary Outcome

Title	Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at Endpoint (12 Weeks or Last Observation After Baseline)
Description	The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning:confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. Responses range from "none of the time" to "all of the time". The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to Endpoint (12 weeks or last observation after baseline).
Time Frame	Baseline and Endpoint (12 weeks or last observation after baseline)

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who had at least one observation after baseline

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	112	110
Least Squares Mean (Standard Error) [Units on a scale]	3.2 (0.56)	2.4 (0.56)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.3320
	Comments
	Method	ANCOVA
	Comments

52. Secondary Outcome

Title	Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 2 Weeks
Description	The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from "none of the time" to "all of the time". The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 2 weeks.
Time Frame	baseline and 2 weeks

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who completed the MOS-CF6 at baseline and at 2 weeks

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	109	104
Least Squares Mean (Standard Error) [Units on a scale]	2.0 (0.57)	1.9 (0.58)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.8930
	Comments
	Method	ANCOVA
	Comments

53. Secondary Outcome

Title	Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 4 Weeks
Description	The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from "none of the time" to "all of the time". The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 4 weeks.
Time Frame	baseline and 4 weeks following start of study drug administration

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who completed the MOS-CF6 at baseline and at 4 weeks

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	109	106
Least Squares Mean (Standard Error) [Units on a scale]	3.4 (0.50)	2.4 (0.51)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1774
	Comments
	Method	ANCOVA
	Comments

54. Secondary Outcome

Title	Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 8 Weeks
Description	The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from "none of the time" to "all of the time". The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 8 weeks.
Time Frame	baseline and 8 weeks following start of study drug administration

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who completed the MOS-CF6 at baseline and at week 8

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	104	98
Least Squares Mean (Standard Error) [Units on a scale]	3.3 (0.49)	2.1 (0.51)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1000
	Comments
	Method	ANCOVA
	Comments

55. Secondary Outcome

Title	Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 12 Weeks
Description	The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from "none of the time" to "all of the time". The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 12 weeks.
Time Frame	baseline and 12 weeks following start of study drug administration

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who completed MOS-CF6 at baseline and at 12 weeks

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	95	93
Least Squares Mean (Standard Error) [Units on a scale]	3.3 (0.58)	2.4 (0.59)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.2428
	Comments
	Method	ANCOVA
	Comments

56. Secondary Outcome

Title	Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at Endpoint (12 Weeks or Last Observation After Baseline)
Description	The Excessive Sleepiness Symptom Rating Form was used to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(tiredness, fatigue, sleepiness, lack of energy, trouble paying attention, forgetfulness, trouble staying organized) on an 11-point Likert scale (0 = no problem at all to 10 = as bad as you can imagine). ES Symptom Rating Form was designed to follow the response to treatment measuring severity of each of these 7 symptoms using the same 11-point scale. Change from Baseline to Endpoint (12 weeks or last baseline observation) is presented only for the symptom of "Sleepiness".
Time Frame	Baseline and Endpoint (12 weeks or last observation after baseline)

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects with at least one observation after baseline

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	112	111
Least Squares Mean (Standard Error) [Units on a scale]	-1.8 (0.24)	-1.4 (0.24)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1816
	Comments
	Method	ANCOVA
	Comments

57. Secondary Outcome

Title	Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 2 Weeks
Description	Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0="no problem at all" 10="as bad as you can imagine"). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 2 Weeks is presented only for the symptom of "Sleepiness".
Time Frame	Baseline and 2 weeks

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who completed the ES Symptom Rating form at baseline and 2 weeks

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	106	105
Least Squares Mean (Standard Error) [Units on a scale]	-1.6 (0.22)	-1.2 (0.22)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1627
	Comments
	Method	ANCOVA
	Comments

58. Secondary Outcome

Title	Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 4 Weeks
Description	Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0="no problem at all" 10="as bad as you can imagine"). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 4 Weeks is presented only for the symptom of "Sleepiness".
Time Frame	Baseline and 4 weeks following start of study drug administration

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who completed the ES Symptom Rating Form at Baseline and at 4 weeks

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	110	106
Least Squares Mean (Standard Error) [Units on a scale]	-2.1 (0.23)	-1.1 (0.23)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0018
	Comments
	Method	ANCOVA
	Comments

59. Secondary Outcome

Title	Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 8 Weeks
Description	Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0="no problem at all" 10="as bad as you can imagine"). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 8 Weeks is presented only for the symptom of "Sleepiness".
Time Frame	baseline and 8 weeks following start of study drug administration

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who completed the ES Symptom Rating Form at baseline and at 8 weeks

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	103	98
Least Squares Mean (Standard Error) [Units on a scale]	-1.8 (0.24)	-0.9 (0.25)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0096
	Comments
	Method	ANCOVA
	Comments

60. Secondary Outcome

Title	Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 12 Weeks
Description	Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0="no problem at all" 10="as bad as you can imagine"). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 12 Weeks is presented only for the symptom of "Sleepiness".
Time Frame	Baseline and 12 weeks following start of study drug administration

Outcome Measure Data

Analysis Population Description
Full analysis set defined as subjects who completed the ES Symptom Rating Form at baseline and at 12 weeks

Arm/Group Title	Armodafinil 200 mg/Day	Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.	Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
Measure Participants	95	94
Least Squares Mean (Standard Error) [Units on a scale]	-2.2 (0.25)	-1.3 (0.25)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Armodafinil 200 mg/Day, Placebo
	Comments	Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0126
	Comments
	Method	ANCOVA
	Comments

Adverse Events

	Armodafinil 200 mg/Day		Placebo
Time Frame
Adverse Event Reporting Description

Arm/Group Title	Armodafinil 200 mg/Day		Placebo
Arm/Group Description	Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.		Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Armodafinil 200 mg/Day		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/124 (0.8%)		3/124 (2.4%)
Cardiac disorders
Angina unstable	0/124 (0%)	0	1/124 (0.8%)	0
General disorders
Chest pain	1/124 (0.8%)		0/124 (0%)	0
Hepatobiliary disorders
Cholelithiasis	0/124 (0%)	0	1/124 (0.8%)	0
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis	0/124 (0%)	0	1/124 (0.8%)	0
Intervertebral disc protrusion	0/124 (0%)	0	1/124 (0.8%)	0
Other (Not Including Serious) Adverse Events
	Armodafinil 200 mg/Day		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	56/124 (45.2%)		34/124 (27.4%)
Gastrointestinal disorders
Dry Mouth	10/124 (8.1%)		0/124 (0%)
Nausea	8/124 (6.5%)		5/124 (4%)
Diarrhoea	5/124 (4%)		3/124 (2.4%)
General disorders
Irritability	5/124 (4%)		1/124 (0.8%)
Feeling jittery	4/124 (3.2%)		1/124 (0.8%)
Infections and infestations
Upper respiratory tract infection	8/124 (6.5%)		7/124 (5.6%)
Nasopharyngitis	5/124 (4%)		6/124 (4.8%)
Nervous system disorders
Headache	14/124 (11.3%)		9/124 (7.3%)
Dizziness	5/124 (4%)		3/124 (2.4%)
Psychiatric disorders
Insomnia	9/124 (7.3%)		2/124 (1.6%)
Anxiety	6/124 (4.8%)		1/124 (0.8%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	4/124 (3.2%)		1/124 (0.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Results Point of Contact

Name/Title	Medical monitor
Organization	Cephalon, Inc.
Phone	1-800-896-5855
Email

Responsible Party:

Cephalon

ClinicalTrials.gov Identifier:

NCT00518986

Other Study ID Numbers:

C10953/4024/ES/US

First Posted:

Aug 21, 2007

Last Update Posted:

Jul 19, 2013

Last Verified:

Jul 1, 2013