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Pharmacodynamic Profile of SPD489 in Healthy Adult Males Undergoing a Nocturnal Period of Acute Sleep Loss

Sponsor
Shire (Industry)
Overall Status
Completed
CT.gov ID
NCT01096680
Collaborator
(none)
135
Enrollment
1
Location
5
Arms
3.4
Actual Duration (Months)
39.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a double-blind, single center, parallel group, placebo and active comparator, controlled study to characterize the wake promoting effects of single doses of SPD489 in healthy adult male undergoing acute sleep deprivation.

Condition or Disease Intervention/Treatment Phase
  • Drug: SPD489 20 mg
  • Drug: SPD489 50 mg
  • Drug: SPD489 70 mg
  • Drug: Armodafinil
  • Drug: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
135 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
A Phase 2, Randomized, Double-Blind, Single Center, Parallel Group, Placebo and Active Comparator, Controlled Study to Evaluate the Pharmacodynamic Profile of Single Doses of SPD489 in Healthy Adult Male Subjects Undergoing a Nocturnal Period of Acute Sleep Loss
Actual Study Start Date :
Apr 5, 2010
Actual Primary Completion Date :
Jul 18, 2010
Actual Study Completion Date :
Jul 18, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: SPD489 20 mg

Drug: SPD489 20 mg
Single oral dose of 20 mg
Other Names:
  • Vyvanse

    		•
    Experimental: SPD489 50 mg

    Drug: SPD489 50 mg
    Single oral dose of 50 mg
    Other Names:
  • Vyvanse

    		•
    Experimental: SPD489 70 mg

    Drug: SPD489 70 mg
    Single oral dose of 70 mg
    Other Names:
  • Vyvanse

    		•
    Active Comparator: Armodafinil

    Drug: Armodafinil
    Single oral dose of 250 mg
    Placebo Comparator: Placebo

    Drug: Placebo
    Single oral dose

    Outcome Measures

    Primary Outcome Measures

    1. Maintenance of Wakefulness Test (MWT) [Over a period of 8 hours]

      The MWT was conducted to determine the subjects' ability to stay awake. Subjects sat in a darkened room and were told to "stay awake as long as possible" during the 30 minute session. This is an indicator of how well you are able to function and remain alert in quiet times of inactivity. Higher times are better.

    Secondary Outcome Measures

    1. Karolinska Sleepiness Scale (KSS) Scores [Over a period of 15 hours]

      The KSS is a 9-point scale on which the subject rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep). Lower score is better.

    2. KSS Scores by Timepoint [Over a period of 15 hours]

      The KSS is a 9-point scale on which the subject rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep). Lower score is better.

    3. Psychomotor Vigilance Task (PVT) Scores [Over a period of 12 hours]

      PVT assesses behavioral alertness. Subjects were required to respond to a visual stimulus by pressing a button on a mechanical device and the reaction time was measured. Higher scores indicate attention lapses.

    4. PVT Scores by Timepoint [Over a period of 12 hours]

      PVT assesses behavioral alertness. Subjects were required to respond to a visual stimulus by pressing a button on a mechanical device and the reaction time was measured. Higher scores indicate attention lapses.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Male subjects between the ages of 18-40 years.

    • The subject is in good health and must have a satisfactory medical assessment with no clinically significant and relevant abnormalities (of medical history, physical examination, electrocardiogram (ECG), clinical laboratory evaluation (hematology, biochemistry, and urinalysis).

    • Subject has a history of regular sleep-wake habits, routinely spending 6.5-8 hours in bed nightly, and does not oversleep by more than 3 hours on weekends.

    • Subject has the ability to provide written, signed, and dated (personally) informed consent to participate in the study, in accordance with the International Conference on Harmonisation Good Clinical Practice Guideline E6 and applicable regulations, before completing any study-related procedures.

    Exclusion Criteria:

    • Current or relevant previous history of serious, severe, or unstable (acute or progressive) physical or psychiatric illness, any medical disorder that may require treatment or make this subject unlikely to fully complete the study, or any condition that presents undue risk from SPD489 or armodafinil or procedures. Comorbid psychiatric diagnosis will be established by a psychiatric evaluation that includes the Mini International Neuropsychiatric Interview (MINI)-Plus.

    • Subject is currently considered a suicide risk, has previously made a suicide attempt, or has a prior history of, or is currently demonstrating suicidal ideation.

    • Subject has a known or suspected sleep disorder, or another disorder associated with excessive daytime sleepiness, or any other diagnosis that would interfere with assessing sleepiness in subjects with study related induced sleepiness or abnormal findings on the initial PSG conducted on Day -1 such as, but not limited to, Apnea-Hypopnea Index (AHI) or Periodic Limb Movement Arousal Index (PLMAI) >10.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinilabs, Inc. New York New York United States 10019

    Sponsors and Collaborators

    • Shire

    Investigators

    • Study Director: Study Director, Takeda

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shire
    ClinicalTrials.gov Identifier:
    NCT01096680
    Other Study ID Numbers:
    • SPD489-207
    First Posted:
    Mar 31, 2010
    Last Update Posted:
    Jun 14, 2021
    Last Verified:
    Jun 1, 2021
    Additional relevant MeSH terms:
    Sleep Deprivation
    Lisdexamfetamine Dimesylate
    Modafinil

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title SPD489 20 mg SPD489 50 mg SPD489 70 mg Armodafinil 250 mg Placebo
    Arm/Group Description A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
    Period Title: Overall Study
    STARTED 27 27 27 27 27
    COMPLETED 27 27 27 27 27
    NOT COMPLETED 0 0 0 0 0

    Baseline Characteristics

    Arm/Group Title SPD489 20 mg SPD489 50 mg SPD489 70 mg Armodafinil 250 mg Placebo Total
    Arm/Group Description A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation Total of all reporting groups
    Overall Participants 27 27 27 27 27 135
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    26.4
    (5.03)
    28.7
    (5.95)
    28.3
    (5.04)
    27.0
    (5.09)
    28.1
    (6.83)
    27.7
    (5.62)
    Age, Customized (Count of Participants)
    18 to 40 years
    27
    100%
    27
    100%
    27
    100%
    27
    100%
    27
    100%
    135
    100%
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Male
    27
    100%
    27
    100%
    27
    100%
    27
    100%
    27
    100%
    135
    100%
    Region of Enrollment (Count of Participants)
    United States
    27
    100%
    27
    100%
    27
    100%
    27
    100%
    27
    100%
    135
    100%

    Outcome Measures

    1. Primary Outcome
    Title Maintenance of Wakefulness Test (MWT)
    Description The MWT was conducted to determine the subjects' ability to stay awake. Subjects sat in a darkened room and were told to "stay awake as long as possible" during the 30 minute session. This is an indicator of how well you are able to function and remain alert in quiet times of inactivity. Higher times are better.
    Time Frame Over a period of 8 hours

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set (FAS) is defined as all randomized subjects with any primary efficacy assessment.
    Arm/Group Title SPD489 20 mg SPD489 50 mg SPD489 70 mg Armodafinil 250 mg Placebo
    Arm/Group Description A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
    Measure Participants 27 27 27 27 27
    Least Squares Mean (Standard Error) [Minutes]
    23.3
    (1.10)
    27.9
    (0.64)
    29.3
    (0.44)
    27.6
    (0.63)
    15.3
    (1.00)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 8.0
    Confidence Interval (2-Sided) 95%
    5.0 to 10.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 12.6
    Confidence Interval (2-Sided) 95%
    10.2 to 15.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 14.0
    Confidence Interval (2-Sided) 95%
    11.7 to 16.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Armodafinil 250 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 12.3
    Confidence Interval (2-Sided) 95%
    9.9 to 14.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Armodafinil 250 mg
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0014
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -4.3
    Confidence Interval (2-Sided) 95%
    -6.9 to -1.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Armodafinil 250 mg
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.7601
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.3
    Confidence Interval (2-Sided) 95%
    -1.5 to 2.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Armodafinil 250 mg
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0351
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.7
    Confidence Interval (2-Sided) 95%
    0.1 to 3.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Karolinska Sleepiness Scale (KSS) Scores
    Description The KSS is a 9-point scale on which the subject rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep). Lower score is better.
    Time Frame Over a period of 15 hours

    Outcome Measure Data

    Analysis Population Description
    FAS
    Arm/Group Title SPD489 20 mg SPD489 50 mg SPD489 70 mg Armodafinil 250 mg Placebo
    Arm/Group Description A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
    Measure Participants 27 27 27 27 27
    Least Squares Mean (Standard Error) [Units on a scale]
    4.7
    (0.21)
    4.0
    (0.21)
    3.6
    (0.21)
    4.7
    (0.21)
    5.2
    (0.21)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.1123
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -1.1 to 0.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.2
    Confidence Interval (2-Sided) 95%
    -1.8 to -0.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.6
    Confidence Interval (2-Sided) 95%
    -2.2 to -1.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Armodafinil 250 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0947
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -1.1 to 0.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Armodafinil 250 mg
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.9393
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.0
    Confidence Interval (2-Sided) 95%
    -0.6 to 0.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Armodafinil 250 mg
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0297
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95%
    -1.3 to -0.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Armodafinil 250 mg
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.1
    Confidence Interval (2-Sided) 95%
    -1.7 to -0.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    Title KSS Scores by Timepoint
    Description The KSS is a 9-point scale on which the subject rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep). Lower score is better.
    Time Frame Over a period of 15 hours

    Outcome Measure Data

    Analysis Population Description
    FAS
    Arm/Group Title SPD489 20 mg SPD489 50 mg SPD489 70 mg Armodafinil 250 mg Placebo
    Arm/Group Description A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
    Measure Participants 27 27 27 27 27
    7:50pm
    2.9
    (0.19)
    3.0
    (0.19)
    2.6
    (0.19)
    2.6
    (0.19)
    2.8
    (0.19)
    8:50pm
    2.7
    (0.20)
    2.7
    (0.20)
    2.6
    (0.20)
    2.7
    (0.20)
    3.0
    (0.20)
    9:50pm
    2.9
    (0.23)
    3.1
    (0.23)
    2.6
    (0.23)
    3.1
    (0.23)
    3.1
    (0.23)
    10:50pm
    2.8
    (0.26)
    3.2
    (0.26)
    2.4
    (0.27)
    2.9
    (0.26)
    3.7
    (0.27)
    11:50pm
    3.2
    (0.29)
    3.1
    (0.29)
    2.5
    (0.29)
    3.4
    (0.29)
    3.9
    (0.29)
    12:50am
    3.6
    (0.29)
    2.9
    (0.29)
    2.6
    (0.29)
    3.3
    (0.29)
    4.5
    (0.29)
    1:50am
    4.0
    (0.31)
    3.2
    (0.31)
    3.0
    (0.31)
    3.8
    (0.31)
    4.7
    (0.31)
    2:50am
    4.5
    (0.35)
    3.7
    (0.35)
    3.5
    (0.35)
    4.7
    (0.35)
    5.7
    (0.35)
    3:50am
    5.2
    (0.36)
    3.9
    (0.36)
    3.7
    (0.36)
    5.5
    (0.36)
    6.4
    (0.36)
    4:50am
    6.1
    (0.36)
    4.4
    (0.36)
    4.2
    (0.36)
    6.0
    (0.36)
    6.6
    (0.36)
    5:50am
    6.7
    (0.37)
    5.1
    (0.37)
    4.6
    (0.37)
    6.3
    (0.37)
    7.1
    (0.37)
    6:50am
    6.7
    (0.38)
    5.7
    (0.38)
    4.8
    (0.38)
    6.7
    (0.38)
    7.3
    (0.38)
    7:50am
    6.5
    (0.39)
    5.5
    (0.39)
    4.7
    (0.39)
    6.6
    (0.39)
    7.2
    (0.39)
    8:50am
    5.9
    (0.41)
    5.0
    (0.41)
    4.4
    (0.41)
    6.0
    (0.41)
    5.4
    (0.41)
    9:50am
    5.6
    (0.38)
    4.6
    (0.38)
    4.5
    (0.38)
    5.7
    (0.38)
    5.9
    (0.38)
    10:50am
    6.2
    (0.41)
    5.4
    (0.41)
    5.0
    (0.41)
    6.0
    (0.41)
    6.2
    (0.41)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Placebo
    Comments 7:50pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.7758
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.1
    Confidence Interval (2-Sided) 95%
    -0.5 to 0.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Armodafinil 250 mg
    Comments 7:50pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.1798
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.4
    Confidence Interval (2-Sided) 95%
    -0.2 to 0.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Placebo
    Comments 7:50pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.6090
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.1
    Confidence Interval (2-Sided) 95%
    -0.4 to 0.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Armodafinil 250 mg
    Comments 7:50pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.1169
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.4
    Confidence Interval (2-Sided) 95%
    -0.1 to 1.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Placebo
    Comments 7:50pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.3028
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.8 to 0.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Armodafinil 250 mg
    Comments 7:50pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.9831
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.0
    Confidence Interval (2-Sided) 95%
    -0.5 to 0.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Armodafinil 250 mg, Placebo
    Comments 7:50pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.2887
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.8 to 0.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Placebo
    Comments 8:50pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.4395
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.8 to 0.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Armodafinil 250 mg
    Comments 8:50pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.9019
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.0
    Confidence Interval (2-Sided) 95%
    -0.5 to 0.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Placebo
    Comments 8:50pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.3419
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.8 to 0.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Armodafinil 250 mg
    Comments 8:50pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.9581
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.0
    Confidence Interval (2-Sided) 95%
    -0.6 to 0.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Placebo
    Comments 8:50pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.2572
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.9 to 0.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Armodafinil 250 mg
    Comments 8:50pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.8085
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -0.6 to 0.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Armodafinil 250 mg, Placebo
    Comments 8:50pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.3678
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.8 to 0.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Placebo
    Comments 9:50pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.3732
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -0.9 to 0.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Armodafinil 250 mg
    Comments 9:50pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.4924
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.9 to 0.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Placebo
    Comments 9:50pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.9798
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.0
    Confidence Interval (2-Sided) 95%
    -0.7 to 0.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Armodafinil 250 mg
    Comments 9:50pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.8557
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.1
    Confidence Interval (2-Sided) 95%
    -0.6 to 0.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Placebo
    Comments 9:50pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0998
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -1.2 to 0.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Armodafinil 250 mg
    Comments 9:50pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.1479
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -1.1 to 0.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Armodafinil 250 mg, Placebo
    Comments 9:50pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.8358
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -0.7 to 0.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Placebo
    Comments 10:50pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0199
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.9
    Confidence Interval (2-Sided) 95%
    -1.6 to -0.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Armodafinil 250 mg
    Comments 10:50pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.7625
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -0.9 to 0.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Placebo
    Comments 10:50pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.1936
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -1.2 to 0.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Armodafinil 250 mg
    Comments 10:50pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.4534
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.3
    Confidence Interval (2-Sided) 95%
    -0.5 to 1.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Placebo
    Comments 10:50pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0012
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.2
    Confidence Interval (2-Sided) 95%
    -2.0 to -0.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Armodafinil 250 mg
    Comments 10:50pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.2072
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -1.2 to 0.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Armodafinil 250 mg, Placebo
    Comments 10:50pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0413
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -1.5 to 0.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Placebo
    Comments 11:50pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.1086
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95%
    -1.5 to 0.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Armodafinil 250 mg
    Comments 11:50pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.5843
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -1.0 to 0.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Placebo
    Comments 11:50pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0571
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -1.6 to 0.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Armodafinil 250 mg
    Comments 11:50pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.3965
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -1.2 to 0.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Placebo
    Comments 11:50pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0009
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.4
    Confidence Interval (2-Sided) 95%
    -2.2 to -0.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Armodafinil 250 mg
    Comments 11:50pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0211
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.0
    Confidence Interval (2-Sided) 95%
    -1.8 to -0.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection Armodafinil 250 mg, Placebo
    Comments 11:50pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.2863
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -1.2 to 0.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Placebo
    Comments 12:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0428
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -1.7 to 0.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Armodafinil 250 mg
    Comments 12:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.3757
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.4
    Confidence Interval (2-Sided) 95%
    -0.5 to 1.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Placebo
    Comments 12:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.6
    Confidence Interval (2-Sided) 95%
    -2.4 to -0.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Armodafinil 250 mg
    Comments 12:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.3535
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -1.2 to 0.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Placebo
    Comments 12:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.9
    Confidence Interval (2-Sided) 95%
    -2.7 to -1.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 41
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Armodafinil 250 mg
    Comments 12:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.1131
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95%
    -1.5 to 0.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 42
    Statistical Analysis Overview Comparison Group Selection Armodafinil 250 mg, Placebo
    Comments 12:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0039
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.2
    Confidence Interval (2-Sided) 95%
    -2.0 to -0.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 43
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Placebo
    Comments 1:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.1302
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95%
    -1.5 to 0.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 44
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Armodafinil 250 mg
    Comments 1:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.6138
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.2
    Confidence Interval (2-Sided) 95%
    -0.6 to 1.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 45
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Placebo
    Comments 1:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0008
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.5
    Confidence Interval (2-Sided) 95%
    -2.3 to -0.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 46
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Armodafinil 250 mg
    Comments 1:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.1643
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -1.5 to 0.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 47
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Placebo
    Comments 1:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.7
    Confidence Interval (2-Sided) 95%
    -2.5 to -0.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 48
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Armodafinil 250 mg
    Comments 1:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0782
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -1.6 to 0.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 49
    Statistical Analysis Overview Comparison Group Selection Armodafinil 250 mg, Placebo
    Comments 1:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0441
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.9
    Confidence Interval (2-Sided) 95%
    -1.7 to 0.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 50
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Placebo
    Comments 2:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0193
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.2
    Confidence Interval (2-Sided) 95%
    -2.2 to -0.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 51
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Armodafinil 250 mg
    Comments 2:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.7071
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -1.2 to 0.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 52
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Placebo
    Comments 2:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.9
    Confidence Interval (2-Sided) 95%
    -2.9 to -0.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 53
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Armodafinil 250 mg
    Comments 2:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0611
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.9
    Confidence Interval (2-Sided) 95%
    -1.9 to 0.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 54
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Placebo
    Comments 2:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -2.2
    Confidence Interval (2-Sided) 95%
    -3.2 to -1.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 55
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Armodafinil 250 mg
    Comments 2:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0160
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.2
    Confidence Interval (2-Sided) 95%
    -2.2 to -0.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 56
    Statistical Analysis Overview Comparison Group Selection Armodafinil 250 mg, Placebo
    Comments 2:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0480
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.0
    Confidence Interval (2-Sided) 95%
    -2.0 to 0.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 57
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Placebo
    Comments 3:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0234
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.2
    Confidence Interval (2-Sided) 95%
    -2.2 to -0.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 58
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Armodafinil 250 mg
    Comments 3:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.5624
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -1.3 to 0.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 59
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Placebo
    Comments 3:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -2.5
    Confidence Interval (2-Sided) 95%
    -3.5 to -1.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 60
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Armodafinil 250 mg
    Comments 3:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0022
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.6
    Confidence Interval (2-Sided) 95%
    -2.6 to -0.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 61
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Placebo
    Comments 3:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -2.7
    Confidence Interval (2-Sided) 95%
    -3.7 to -1.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 62
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Armodafinil 250 mg
    Comments 3:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0008
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.8
    Confidence Interval (2-Sided) 95%
    -2.8 to -0.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 63
    Statistical Analysis Overview Comparison Group Selection Armodafinil 250 mg, Placebo
    Comments 3:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0883
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.9
    Confidence Interval (2-Sided) 95%
    -1.9 to 0.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 64
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Placebo
    Comments 4:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.3093
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -1.5 to 0.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 65
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Armodafinil 250 mg
    Comments 4:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.8871
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.1
    Confidence Interval (2-Sided) 95%
    -0.9 to 1.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 66
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Placebo
    Comments 4:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -2.2
    Confidence Interval (2-Sided) 95%
    -3.2 to -1.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 67
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Armodafinil 250 mg
    Comments 4:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0022
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.6
    Confidence Interval (2-Sided) 95%
    -2.6 to -0.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 68
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Placebo
    Comments 4:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -2.4
    Confidence Interval (2-Sided) 95%
    -3.4 to -1.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 69
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Armodafinil 250 mg
    Comments 4:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.8
    Confidence Interval (2-Sided) 95%
    -2.8 to -0.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 70
    Statistical Analysis Overview Comparison Group Selection Armodafinil 250 mg, Placebo
    Comments 4:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.2462
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -1.6 to 0.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 71
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Placebo
    Comments 5:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.4427
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -1.4 to 0.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 72
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Armodafinil 250 mg
    Comments 5:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.4405
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.4
    Confidence Interval (2-Sided) 95%
    -0.6 to 1.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 73
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Placebo
    Comments 5:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -2.0
    Confidence Interval (2-Sided) 95%
    -3.0 to -0.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 74
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Armodafinil 250 mg
    Comments 5:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0279
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.2
    Confidence Interval (2-Sided) 95%
    -2.2 to -0.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 75
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Placebo
    Comments 5:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -2.5
    Confidence Interval (2-Sided) 95%
    -3.5 to -1.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 76
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Armodafinil 250 mg
    Comments 5:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0015
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.7
    Confidence Interval (2-Sided) 95%
    -2.7 to -0.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 77
    Statistical Analysis Overview Comparison Group Selection Armodafinil 250 mg, Placebo
    Comments 5:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.1246
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -1.8 to 0.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 78
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Placebo
    Comments 6:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.3067
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -1.6 to 0.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 79
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Armodafinil 250 mg
    Comments 6:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.8940
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.1
    Confidence Interval (2-Sided) 95%
    -1.0 to 1.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 80
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Placebo
    Comments 6:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0034
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.6
    Confidence Interval (2-Sided) 95%
    -2.7 to -0.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 81
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Armodafinil 250 mg
    Comments 6:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0708
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.0
    Confidence Interval (2-Sided) 95%
    -2.0 to 0.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 82
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Placebo
    Comments 6:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -2.5
    Confidence Interval (2-Sided) 95%
    -3.6 to -1.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 83
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Armodafinil 250 mg
    Comments 6:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.9
    Confidence Interval (2-Sided) 95%
    -2.9 to -0.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 84
    Statistical Analysis Overview Comparison Group Selection Armodafinil 250 mg, Placebo
    Comments 6:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.2476
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -1.7 to 0.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 85
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Placebo
    Comments 7:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.2310
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95%
    -1.8 to 0.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 86
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Armodafinil 250 mg
    Comments 7:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.8369
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -1.2 to 1.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 87
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Placebo
    Comments 7:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0035
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.6
    Confidence Interval (2-Sided) 95%
    -2.7 to -0.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 88
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Armodafinil 250 mg
    Comments 7:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0498
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.1
    Confidence Interval (2-Sided) 95%
    -2.2 to 0.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 89
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Placebo
    Comments 7:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -2.5
    Confidence Interval (2-Sided) 95%
    -3.6 to -1.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 90
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Armodafinil 250 mg
    Comments 7:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0007
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.9
    Confidence Interval (2-Sided) 95%
    -3.0 to -0.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 91
    Statistical Analysis Overview Comparison Group Selection Armodafinil 250 mg, Placebo
    Comments 7:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.3198
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -1.6 to 0.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 92
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Placebo
    Comments 8:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.3750
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.5
    Confidence Interval (2-Sided) 95%
    -0.6 to 1.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 93
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Armodafinil 250 mg
    Comments 8:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.7978
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -1.3 to 1.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 94
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Placebo
    Comments 8:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.5197
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -1.5 to 0.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 95
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Armodafinil 250 mg
    Comments 8:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0751
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.1
    Confidence Interval (2-Sided) 95%
    -2.2 to 0.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 96
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Placebo
    Comments 8:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.1079
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.0
    Confidence Interval (2-Sided) 95%
    -2.1 to 0.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 97
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Armodafinil 250 mg
    Comments 8:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0065
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.6
    Confidence Interval (2-Sided) 95%
    -2.8 to -0.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 98
    Statistical Analysis Overview Comparison Group Selection Armodafinil 250 mg, Placebo
    Comments 8:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.2529
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.7
    Confidence Interval (2-Sided) 95%
    -0.5 to 1.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 99
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Placebo
    Comments 9:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.6364
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -1.3 to 0.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 100
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Armodafinil 250 mg
    Comments 9:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.9417
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.0
    Confidence Interval (2-Sided) 95%
    -1.1 to 1.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 101
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Placebo
    Comments 9:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0200
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.3
    Confidence Interval (2-Sided) 95%
    -2.3 to -0.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 102
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Armodafinil 250 mg
    Comments 9:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0527
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.1
    Confidence Interval (2-Sided) 95%
    -2.1 to 0.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 103
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Placebo
    Comments 9:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0107
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.4
    Confidence Interval (2-Sided) 95%
    -2.5 to -0.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 104
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Armodafinil 250 mg
    Comments 9:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0303
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.2
    Confidence Interval (2-Sided) 95%
    -2.2 to -0.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 105
    Statistical Analysis Overview Comparison Group Selection Armodafinil 250 mg, Placebo
    Comments 9:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.6889
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -1.3 to 0.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 106
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Placebo
    Comments 10:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.9552
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.0
    Confidence Interval (2-Sided) 95%
    -1.2 to 1.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 107
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Armodafinil 250 mg
    Comments 10:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.7558
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.2
    Confidence Interval (2-Sided) 95%
    -1.0 to 1.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 108
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Placebo
    Comments 10:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.1824
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -1.9 to 0.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 109
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Armodafinil 250 mg
    Comments 10:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.3323
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -1.7 to 0.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 110
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Placebo
    Comments 10:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0413
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.2
    Confidence Interval (2-Sided) 95%
    -2.4 to 0.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 111
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Armodafinil 250 mg
    Comments 10:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0925
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.0
    Confidence Interval (2-Sided) 95%
    -2.2 to 0.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 112
    Statistical Analysis Overview Comparison Group Selection Armodafinil 250 mg, Placebo
    Comments 10:50am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.7133
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -1.4 to 0.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    Title Psychomotor Vigilance Task (PVT) Scores
    Description PVT assesses behavioral alertness. Subjects were required to respond to a visual stimulus by pressing a button on a mechanical device and the reaction time was measured. Higher scores indicate attention lapses.
    Time Frame Over a period of 12 hours

    Outcome Measure Data

    Analysis Population Description
    FAS
    Arm/Group Title SPD489 20 mg SPD489 50 mg SPD489 70 mg Armodafinil 250 mg Placebo
    Arm/Group Description A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
    Measure Participants 27 27 27 27 27
    Least Squares Mean (Standard Error) [msec]
    243.6
    (3.59)
    234.8
    (3.58)
    243.5
    (3.58)
    243.7
    (3.59)
    270.2
    (3.59)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -26.5
    Confidence Interval (2-Sided) 95%
    -36.6 to -16.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -35.4
    Confidence Interval (2-Sided) 95%
    -45.5 to -25.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -26.7
    Confidence Interval (2-Sided) 95%
    -36.7 to -16.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Armodafinil 250 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -26.5
    Confidence Interval (2-Sided) 95%
    -36.6 to -16.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Armodafinil 250 mg
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.9945
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.0
    Confidence Interval (2-Sided) 95%
    -10.1 to 10.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Armodafinil 250 mg
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0814
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -8.9
    Confidence Interval (2-Sided) 95%
    -18.9 to 1.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Armodafinil 250 mg
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.9743
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -10.2 to 9.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    5. Secondary Outcome
    Title PVT Scores by Timepoint
    Description PVT assesses behavioral alertness. Subjects were required to respond to a visual stimulus by pressing a button on a mechanical device and the reaction time was measured. Higher scores indicate attention lapses.
    Time Frame Over a period of 12 hours

    Outcome Measure Data

    Analysis Population Description
    FAS
    Arm/Group Title SPD489 20 mg SPD489 50 mg SPD489 70 mg Armodafinil 250 mg Placebo
    Arm/Group Description A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
    Measure Participants 27 27 27 27 27
    9:15pm
    231.6
    (3.50)
    233.2
    (3.49)
    234.9
    (3.49)
    235.5
    (3.49)
    241.3
    (3.50)
    11:15pm
    232.6
    (2.98)
    230.9
    (2.97)
    231.2
    (2.97)
    229.3
    (2.97)
    249.3
    (2.98)
    1:15am
    231.5
    (3.89)
    231.5
    (3.88)
    230.2
    (3.89)
    233.0
    (3.88)
    256.7
    (3.89)
    3:15am
    243.6
    (4.65)
    227.4
    (4.64)
    240.7
    (4.64)
    242.5
    (4.64)
    280.7
    (4.65)
    5:15am
    253.4
    (4.67)
    237.7
    (4.66)
    242.5
    (4.66)
    249.5
    (4.66)
    291.6
    (4.67)
    7:15am
    257.9
    (7.67)
    242.6
    (7.67)
    259.2
    (7.67)
    259.1
    (7.67)
    295.5
    (7.67)
    9:15am
    254.8
    (10.84)
    240.0
    (10.84)
    265.9
    (10.84)
    256.7
    (10.93)
    276.1
    (10.84)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Placebo
    Comments 9:15pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0544
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -9.6
    Confidence Interval (2-Sided) 95%
    -19.4 to 0.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Armodafinil 250 mg
    Comments 9:15pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.4410
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -3.8
    Confidence Interval (2-Sided) 95%
    -13.6 to 6.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Placebo
    Comments 9:15pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.1046
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -8.1
    Confidence Interval (2-Sided) 95%
    -17.9 to 1.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Armodafinil 250 mg
    Comments 9:15pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.6467
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -2.3
    Confidence Interval (2-Sided) 95%
    -12.0 to 7.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Placebo
    Comments 9:15pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.1971
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -6.4
    Confidence Interval (2-Sided) 95%
    -16.2 to 3.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Armodafinil 250 mg
    Comments 9:15pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.9052
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -10.4 to 9.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Armodafinil 250 mg, Placebo
    Comments 9:15pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.2420
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -5.8
    Confidence Interval (2-Sided) 95%
    -15.6 to 4.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Placebo
    Comments 11:15pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -16.7
    Confidence Interval (2-Sided) 95%
    -25.1 to -8.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Armodafinil 250 mg
    Comments 11:15pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.4321
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 3.3
    Confidence Interval (2-Sided) 95%
    -5.0 to 11.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Placebo
    Comments 11:15pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -18.4
    Confidence Interval (2-Sided) 95%
    -26.7 to -10.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Armodafinil 250 mg
    Comments 11:15pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.6999
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.6
    Confidence Interval (2-Sided) 95%
    -6.7 to 9.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Placebo
    Comments 11:15pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -18.1
    Confidence Interval (2-Sided) 95%
    -26.4 to -9.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Armodafinil 250 mg
    Comments 11:15pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.6566
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.9
    Confidence Interval (2-Sided) 95%
    -6.4 to 10.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Armodafinil 250 mg, Placebo
    Comments 11:15pm
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -20.0
    Confidence Interval (2-Sided) 95%
    -28.3 to -11.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Placebo
    Comments 1:15am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -25.2
    Confidence Interval (2-Sided) 95%
    -36.1 to -14.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Armodafinil 250 mg
    Comments 1:15am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.7824
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.5
    Confidence Interval (2-Sided) 95%
    -12.4 to 9.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Placebo
    Comments 1:15am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -25.1
    Confidence Interval (2-Sided) 95%
    -36.0 to -14.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Armodafinil 250 mg
    Comments 1:15am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.7867
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.5
    Confidence Interval (2-Sided) 95%
    -12.4 to 9.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Placebo
    Comments 1:15am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -26.5
    Confidence Interval (2-Sided) 95%
    -37.4 to -15.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Armodafinil 250 mg
    Comments 1:15am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.6029
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -2.9
    Confidence Interval (2-Sided) 95%
    -13.7 to 8.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Armodafinil 250 mg, Placebo
    Comments 1:15am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -23.6
    Confidence Interval (2-Sided) 95%
    -34.5 to -12.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Placebo
    Comments 3:15am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -37.1
    Confidence Interval (2-Sided) 95%
    -50.1 to -24.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Armodafinil 250 mg
    Comments 3:15am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.8684
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.1
    Confidence Interval (2-Sided) 95%
    -11.9 to 14.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Placebo
    Comments 3:15am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -53.3
    Confidence Interval (2-Sided) 95%
    -66.3 to -40.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Armodafinil 250 mg
    Comments 3:15am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0228
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -15.1
    Confidence Interval (2-Sided) 95%
    -28.1 to -2.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Placebo
    Comments 3:15am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -40.0
    Confidence Interval (2-Sided) 95%
    -53.0 to -27.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Armodafinil 250 mg
    Comments 3:15am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.7852
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.8
    Confidence Interval (2-Sided) 95%
    -14.8 to 11.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Armodafinil 250 mg, Placebo
    Comments 3:15am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -38.2
    Confidence Interval (2-Sided) 95%
    -51.2 to -25.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Placebo
    Comments 5:15am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -38.2
    Confidence Interval (2-Sided) 95%
    -51.3 to -25.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Armodafinil 250 mg
    Comments 5:15am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.5528
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 3.9
    Confidence Interval (2-Sided) 95%
    -9.1 to 17.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Placebo
    Comments 5:15am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -53.9
    Confidence Interval (2-Sided) 95%
    -67.0 to -40.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Armodafinil 250 mg
    Comments 5:15am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0747
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -11.8
    Confidence Interval (2-Sided) 95%
    -24.9 to 1.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Placebo
    Comments 5:15am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -49.2
    Confidence Interval (2-Sided) 95%
    -62.2 to -36.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Armodafinil 250 mg
    Comments 5:15am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.2868
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -7.1
    Confidence Interval (2-Sided) 95%
    -20.1 to 6.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection Armodafinil 250 mg, Placebo
    Comments 5:15am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -42.1
    Confidence Interval (2-Sided) 95%
    -55.2 to -29.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Placebo
    Comments 7:15am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0007
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -37.6
    Confidence Interval (2-Sided) 95%
    -59.1 to -16.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 37
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Armodafinil 250 mg
    Comments 7:15am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.9089
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.2
    Confidence Interval (2-Sided) 95%
    -22.7 to 20.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 38
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Placebo
    Comments 7:15am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -52.9
    Confidence Interval (2-Sided) 95%
    -74.3 to -31.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 39
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Armodafinil 250 mg
    Comments 7:15am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.1307
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -16.5
    Confidence Interval (2-Sided) 95%
    -37.9 to 5.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 40
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Placebo
    Comments 7:15am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0011
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -36.3
    Confidence Interval (2-Sided) 95%
    -57.7 to -14.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 41
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Armodafinil 250 mg
    Comments 7:15am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.9903
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.1
    Confidence Interval (2-Sided) 95%
    -21.3 to 21.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 42
    Statistical Analysis Overview Comparison Group Selection Armodafinil 250 mg, Placebo
    Comments 7:15am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0010
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -36.4
    Confidence Interval (2-Sided) 95%
    -57.8 to -14.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 43
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Placebo
    Comments 9:15am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.1655
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -21.4
    Confidence Interval (2-Sided) 95%
    -51.7 to 9.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 44
    Statistical Analysis Overview Comparison Group Selection SPD489 20 mg, Armodafinil 250 mg
    Comments 9:15am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.8975
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -2.0
    Confidence Interval (2-Sided) 95%
    -32.4 to 28.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 45
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Placebo
    Comments 9:15am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0199
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -36.2
    Confidence Interval (2-Sided) 95%
    -66.5 to -5.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 46
    Statistical Analysis Overview Comparison Group Selection SPD489 50 mg, Armodafinil 250 mg
    Comments 9:15am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.2785
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -16.8
    Confidence Interval (2-Sided) 95%
    -47.2 to 13.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 47
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Placebo
    Comments 9:15am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.5048
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -10.3
    Confidence Interval (2-Sided) 95%
    -40.6 to 20.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 48
    Statistical Analysis Overview Comparison Group Selection SPD489 70 mg, Armodafinil 250 mg
    Comments 9:15am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.5533
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 9.1
    Confidence Interval (2-Sided) 95%
    -21.3 to 39.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 49
    Statistical Analysis Overview Comparison Group Selection Armodafinil 250 mg, Placebo
    Comments 9:15am
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.2098
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -19.4
    Confidence Interval (2-Sided) 95%
    -49.9 to 11.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame
    Adverse Event Reporting Description Safety Analysis Set
    Arm/Group Title SPD489 20 mg SPD489 50 mg SPD489 70 mg Armodafinil 250 mg Placebo
    Arm/Group Description A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
    All Cause Mortality
    SPD489 20 mg SPD489 50 mg SPD489 70 mg Armodafinil 250 mg Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    SPD489 20 mg SPD489 50 mg SPD489 70 mg Armodafinil 250 mg Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/27 (0%) 0/27 (0%) 0/27 (0%) 0/27 (0%) 0/27 (0%)
    Other (Not Including Serious) Adverse Events
    SPD489 20 mg SPD489 50 mg SPD489 70 mg Armodafinil 250 mg Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/27 (3.7%) 5/27 (18.5%) 4/27 (14.8%) 3/27 (11.1%) 1/27 (3.7%)
    Gastrointestinal disorders
    Nausea 1/27 (3.7%) 1/27 (3.7%) 2/27 (7.4%) 1/27 (3.7%) 0/27 (0%)
    Vomiting 0/27 (0%) 2/27 (7.4%) 0/27 (0%) 0/27 (0%) 0/27 (0%)
    Nervous system disorders
    Headache 0/27 (0%) 4/27 (14.8%) 2/27 (7.4%) 2/27 (7.4%) 1/27 (3.7%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.

    Results Point of Contact

    Name/Title Study Director
    Organization Shire
    Phone +1 866 842 5335
    Email ClinicalTransparency@shire.com
    Responsible Party:
    Shire
    ClinicalTrials.gov Identifier:
    NCT01096680
    Other Study ID Numbers:
    • SPD489-207
    First Posted:
    Mar 31, 2010
    Last Update Posted:
    Jun 14, 2021
    Last Verified:
    Jun 1, 2021