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Generalized Anxiety Disorder Proof of Concept Efficacy and Safety Study of SEP-225441 (Eszopiclone) In GAD Subjects

Sponsor
Sunovion (Industry)
Overall Status
Completed
CT.gov ID
NCT00616655
Collaborator
(none)
456
Enrollment
57
Locations
3
Arms
11
Duration (Months)
8
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine the safety and efficacy of SEP-225441 (eszopiclone) in subjects with generalized anxiety disorder (GAD).

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

This is a multicenter, randomized, double blind, placebo controlled study of the safety and efficacy of SEP-225441 (eszopiclone) in male and female adult subjects with a diagnosis of generalized anxiety disorder (GAD). The study consists of a screening period of 7-10 days, 8 weeks of treatment, and a 7 day follow-up period. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Study Design

Study Type:
Interventional
Actual Enrollment :
456 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Double Blind, Randomized, Placebo Controlled, Multicenter Study Examining the Efficacy and Safety of SEP-225441 in Subjects With Generalized Anxiety Disorder.
Study Start Date :
Jan 1, 2008
Actual Primary Completion Date :
Dec 1, 2008
Actual Study Completion Date :
Dec 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

SEP-225441 (eszopiclone) total daily dose of 1.5 mg

Drug: eszopiclone
SEP-225441 (eszopiclone) total daily dose of 1.5 mg
Other Names:
  • SEP-225441

    		•
    Active Comparator: 2

    SEP-225441 (eszopiclone) total daily dose of 0.9 mg

    Drug: eszopiclone
    SEP-225441 (eszopiclone) total daily dose of 0.9 mg
    Other Names:
  • SEP-225441

    		•
    Placebo Comparator: 3

    Placebo total daily dose 0.9 mg

    Drug: Placebo
    Placebo total daily dose 0.9 mg

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline to Week 8 in the Total Score on the Hamilton Anxiety Scale (HAM-A), as Assessed by the Site-trained Rater [Baseline to Week 8]

      THe HAM-M was administered by a site-trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-M rating scale. These items included: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. All items are measured on a 5-point scale (0-4). The Ham-A total score can range from 0 to 56 with higher scores indicating higher severity of anxiety symptoms.

    Secondary Outcome Measures

    1. Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score (Except for Week 8) [Baseline, Weeks 2, 4, 6 based on last observation carried forward (LOCF)]

      The HAM-A was administered by a site-trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-A rating scale. These items included: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. all items are measured on a 5-point scale (0-4). Ham-A total score can range from 0 to 56 with higher scores indicating higher severity of anxiety symptoms.

    2. Change in Individual Item Scores on HAM-A [Baseline, Weeks 2, 4, 6, 8]

      The HAM-A was administered by a site trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-A rating scale. These items include: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. All items are measured on a t5-point scale (0-4). Each HAM-A individual item score can range from 0 to 4 with higher scores indicating higher severity of anxiety questions.

    3. Change From Baseline in Clinician Global Impression of Severity (CGI-S) [Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF)]

      The CGI-Swas completed by a board certified psychiatrist and represents the clinician's subjective assessment of severity of the subject's anxiety symptoms as assessed by a 7-scale score for a single question, "Considering your total clinical experience with this particular population, how anxious is the subject at this time?" The score was based on the following scale: 1=normal, not at all anxious; 2=borderline anxious; 3=mildly anxious; 4=moderately anxious; 5=markedly anxious; 6=severly anxious; 7=among the most extremely anxious subjects. CGI-S score can range from 0 to 7, with higher values indicating higher severity.

    4. Clinical Global Impression- Improvement (CGI-I) [Weeks 2, 4, 6, 8, and 9, based on last observation carried forward (LOCF)]

      CGI-I was completed by a board certified psychiatrist and represented the clinician's subjective assessment of improvement of the subject's anxiety symptoms based on the following question, "Compared to his/her condition at Visit 2, how much has he/she changed?" The score was based on the following scale: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. CGI-I score can range from 0 to 7, with higher values indicating less improvement.

    5. Hamilton Anxiety Scale (HAM-A) 50% Anxiolytic Response [Week 2, 4, 6, 8]

      The HAM-A was administered by a site-trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-A rating scale. These items include: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. All items are measured on a 5-point scale (0-4). A 50% anxiolytic response was defined as a 50% or greater reduction from baseline in the HAM-A total score. The Ham-A total score can range from 0 to 56 with higher scores indicating higher severity of anxiety symptoms.

    6. Hamilton Anxiety Scale (HAM-A) Remission [Week 2, 4, 6, 8 based on last observation carried forward (LOCF)]

      The HAM-A was administered by a site-trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-A rating scale. These items include: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. All items are measured on a 5-point scale (0-4). Remission was defined as a HAM-A total score of 7 or less. The Ham-A total score can range from 0 to 56 with higher scores indicating higher severity of anxiety symptoms.

    7. Change From Baseline on Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form [Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF)]

      The Q-LES-Q was completed by the subject and assessed quaility of life based on 16 items, each evaluated on a 5-point scale of overall level of enjoyment/satisfaction: 1=very poor; 2=poor; 3=fair; 4=good; 5=very good. The overall percentage score was computed as a sum of items 1 to 14 as expressed as a percentage of the maximum possible score: Overall Percentage Score = Sum [item 1... item 14]-14)/(70-14 ) *100%. Q-LES-Q overall percentage score can range from 0 to 100, with higher values indicating higher quality of life.

    8. Change From Baseline Insomnia Severity Index (ISI) Total Score [Baseline, Weeks 2, 4, 6, 8, based on lst observation carried forward (LOCF)]

      The ISI was completed by the subject and is an assessment of the severity of insomnia. The administered extended ISI questionnaire consists of 5 items (containing 7 questions, as item 1 contains 3 questions) comprising the original ISI questionnaire, plus 6 quality of life related items (sleep quality, restedness/refreshness upon arising, daytime fatigue, attention/concentration, relationships and mood disturbances), and 2 items assessing duration and frequency of sleep problems. All items, except for the insomnia duration and frequency questions, are measured on a Likert-type 5-point scale (0-4). ISI total score can range from 0 to 28, with higher scores indicating more severe insomnia.

    9. Change From Baseline Sheehan Disability Scale (SDS) [Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF)]

      The SDS was completed by the subject and captured the subject's level of disability. The subject rated the extent to which his or her work, social life or leisure activities, and home life or family responsibilities were impaired by his or her symptoms on a 10-point visual analog scale. SDS total score can range from 0 to 30, with higher scores indicating higher functional impairment.

    10. Change From Baseline Epworth Sleepiness Scale (ESS) [Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF)]

      ESS was completed by the subject and assessed daytime sedation based on 8 items, each presenting a situation for which the subject needed to evaluate how likely he/she is to doze off or fall asleep in contrast to feeling just tired. Each item was evaluated on the following scale: 0 = would never doze; 1 = slight chance of dozing; 2 = moderate chance of dozing; 3 = high chance of dozing. ESS total score can range from 0 to 24, with higher scores indicating higher levels of daytime sleepiness.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Male and female subjects must be between 18 and 50 years of age

    • Subjects must have GAD

    • Subjects must be in otherwise good general health

    Exclusion Criteria:

    • Subject has a documented history of HIV, hepatitis B or hepatitis C.

    • Subject has a recent history (within 6 months of study entry) or current diagnosis of Major Depressive Disorder, panic disorder (or 3 or more panic attacks in the past month). Post Traumatic Stress Disorder, body dysmorphic disorder, eating disorder, or other disorder.

    • Subject has a history or presence of Obsessive-Compulsive Disorder (OCD), any psychotic, bipolar or schizophrenic disorder.

    • Subject has presence or history of antisocial personality or other severe disorder

    • Subject has refractory GAD (previously unresponsive to 2 or more adequate courses of SSRI, SNRI, benzodiazepine or non-benzodiazepine treatment for GAD).

    • Subject has history of seizures, including febrile seizures.

    • Subject has initiated psychotherapeutic intervention with 30 days; however, continued psychotherapy is allowed if stable and not specifically directed at GAD.

    • Subject is undergoing or has undergone electroconvulsive therapy.

    • Subject is a current smoker or has smoked within the last 12 months.

    • Subject has donated blood within the past 30 days or plans to donate during and within 30 days after study participation.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Birmingham Psychiatry Pharaceutical Studies, Inc. Birmingham Alabama United States 35226
    2 Arcadia California United States 91007
    3 Southwestern Research, Inc. Beverly Hills California United States 90210
    4 Southwestern Research, Inc. Burbank California United States 91506
    5 California Clinical Trials Medical Group Glendale California United States 91202
    6 California clinical Trials Medical Group Glendale California United States 91206
    7 Newport Beach California United States 92660
    8 Excell Research Oceanside California United States 92056
    9 California Clinical Trials Medical Group Paramount California United States 90723
    10 Southwestern Research, Inc. Pasadena California United States 91107
    11 California clinical Trials Medical Group San Diego California United States 92123
    12 Stanford Universtiy Medical center Stanford California United States 94302
    13 University of CT Health Center Farmington Connecticut United States 06032
    14 Comprehensive Psychiatric Care, PC Norwich Connecticut United States 06360
    15 Florida Clinical Research Center LLC Bradenton Florida United States 34208
    16 Sarkis Clinical Trials Gainsville Florida United States 32607
    17 Clinical Neuroscience Solutions, Inc. Jacksonville Florida United States 32216
    18 Clinical Neuroscience Solutions, Inc. Orlando Florida United States 32806
    19 Comprehensive NeuroScience, Inc. St. Petersburg Florida United States 33702
    20 Stedman Clinical Trials, LLC Tampa Florida United States 33613
    21 Janus Center for Psychiatric Research West Palm Beach Florida United States 33407
    22 Comprehensive NeuroScience, Inc. Atlanta Georgia United States 30328
    23 Carmen Research Smyrna Georgia United States 30080
    24 Alexian Brothers Center for Psychiatric Research Hoffman Estates Illinois United States 60194
    25 Comprehensive NeuroScience, Inc. Park Ridge Illinois United States 60068
    26 Vince and Associats Clinical Research Overland Park Kansas United States 66212
    27 Clinical Trials Technology, Inc. Prairie Village Kansas United States 66206
    28 Pedia Research, LLC Owensboro Kentucky United States 42301
    29 Pharasite Research, Inc. Baltimore Maryland United States 21208
    30 Massachusetts General Hospital Boston Massachusetts United States 02114
    31 Coastal Research Associates, Inc. Braintree Massachusetts United States 02184
    32 Center for Emotional Fitness Cherry Hill New Jersey United States 08002
    33 CRI Worldwide, LLC Clementon New Jersey United States 08021
    34 Social Psychiatry Research Institute Brooklyn New York United States 11235
    35 Neurobehavioral Research, Inc. Cedarhurst New York United States 11516
    36 Comprehensive NeuroScience, Inc. Fresh Meadows New York United States 11366
    37 Fieve Clinica Services, Inc. New York New York United States 10021
    38 Medical & Behavioral Health Research, PC New York New York United States 10021
    39 Medical & Behavioral Health Research, P.C. New York New York United States 10023
    40 Richmond Behavioral Associates Staten Island New York United States 10312
    41 Glenwood Psychiatric Associates, P.L.L.C. Raleigh North Carolina United States 27609
    42 Horizon Medical Services Bismarck North Dakota United States 58501
    43 North Coast Clinical Trials Beachwood Ohio United States 44122
    44 Patient Priority Clinical Sties, LLC Cincinnati Ohio United States 45242
    45 Midwest Clinical Research Center Dayton Ohio United States 45408
    46 North Star Mdical Research, LLC Middleburg Heights Ohio United States 44130
    47 IPS Research Company Oklahoma City Oklahoma United States 73103
    48 Oregon Center for Clinical Investigations, Inc. Eugene Oregon United States 97401
    49 Oregon Center for Clinical Investigations, Inc. Salem Oregon United States 97301
    50 CRI Worldwide, LLC Philadelphia Pennsylvania United States 19139
    51 rhode Island Mood & Memory Research Institute East Providence Rhode Island United States 02915
    52 Clinical Neuroscience Solutions, Inc. Memphis Tennessee United States 38119
    53 Future Search Trials Austin Texas United States 78756
    54 Carolos Guerra, Jr., M.D. Houston Texas United States 77042
    55 San Antonio Psychiatric Research Center San Antonio Texas United States 78229
    56 Grayline Clinical Drug Trials Wichita Falls Texas United States 76309
    57 University of Virginia, Center for Psychiatric Clinical Research Charlottesville Virginia United States 22903

    Sponsors and Collaborators

    • Sunovion

    Investigators

    • Study Director: CNS Medical Director, Sunovion

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sunovion
    ClinicalTrials.gov Identifier:
    NCT00616655
    Other Study ID Numbers:
    • 194-027
    First Posted:
    Feb 15, 2008
    Last Update Posted:
    Apr 8, 2016
    Last Verified:
    Mar 1, 2016
    Keywords provided by Sunovion
    Anxiety
    Additional relevant MeSH terms:
    Anxiety Disorders
    Eszopiclone

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Placebo Arm Eszopiclone Low Dose Arm Eszopiclone High Dose Arm
    Arm/Group Description Placebo SEP-225441 (eszopiclone) total daily dose of 0.9 mg SEP-225441 (eszopiclone) total daily dose of 1.5 mg
    Period Title: Overall Study
    STARTED 152 153 151
    COMPLETED 117 112 103
    NOT COMPLETED 35 41 48

    Baseline Characteristics

    Arm/Group Title Placebo Arm Eszopiclone Low Dose Arm Eszopiclone High Dose Arm Total
    Arm/Group Description Placebo SEP-225441 (eszopiclone) total daily dose of 0.9 mg SEP-225441 (eszopiclone) total daily dose of 1.5 mg Total of all reporting groups
    Overall Participants 149 146 145 440
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    149
    100%
    146
    100%
    145
    100%
    440
    100%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Sex: Female, Male (Count of Participants)
    Female
    111
    74.5%
    108
    74%
    102
    70.3%
    321
    73%
    Male
    38
    25.5%
    38
    26%
    43
    29.7%
    119
    27%
    Region of Enrollment (participants) [Number]
    United States
    149
    100%
    146
    100%
    145
    100%
    440
    100%

    Outcome Measures

    1. Primary Outcome
    Title Change From Baseline to Week 8 in the Total Score on the Hamilton Anxiety Scale (HAM-A), as Assessed by the Site-trained Rater
    Description THe HAM-M was administered by a site-trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-M rating scale. These items included: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. All items are measured on a 5-point scale (0-4). The Ham-A total score can range from 0 to 56 with higher scores indicating higher severity of anxiety symptoms.
    Time Frame Baseline to Week 8

    Outcome Measure Data

    Analysis Population Description
    ITT Population: /The ITT population will include all randomized subjects who received at least one does of study medication during the double-blind period.
    Arm/Group Title Placebo Arm Eszopiclone Low Dose Arm Eszopiclone High Dose Arm
    Arm/Group Description Placebo SEP-225441 (eszopiclone) total daily dose of 0.9 mg SEP-225441 (eszopiclone) total daily dose of 1.5 mg
    Measure Participants 149 146 145
    Mean (Standard Deviation) [Units on a scale]
    -10.0
    (7.0)
    -9.3
    (7.4)
    -9.5
    (8.1)
    2. Secondary Outcome
    Title Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score (Except for Week 8)
    Description The HAM-A was administered by a site-trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-A rating scale. These items included: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. all items are measured on a 5-point scale (0-4). Ham-A total score can range from 0 to 56 with higher scores indicating higher severity of anxiety symptoms.
    Time Frame Baseline, Weeks 2, 4, 6 based on last observation carried forward (LOCF)

    Outcome Measure Data

    Analysis Population Description
    ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.
    Arm/Group Title Placebo Arm Eszopiclone Low Dose Arm Eszopiclone High Dose Arm
    Arm/Group Description Placebo SEP-225441 (eszopiclone) total daily dose of 0.9 mg SEP-225441 (eszopiclone) total daily dose of 1.5 mg
    Measure Participants 149 146 145
    Baseline
    24.2
    (3.4)
    24.0
    (3.4)
    24.0
    (3.7)
    Week 2 - Change from baseline
    -5.7
    (5.7)
    -4.8
    (5.0)
    -6.0
    (6.1)
    Week 4-Change from baseline
    -8.1
    (6.0)
    -7.6
    (6.3)
    -8.0
    (6.8)
    Week 6- Change from baseline
    -8.9
    (6.3)
    -8.7
    (7.2)
    -8.5
    (7.4)
    3. Secondary Outcome
    Title Change in Individual Item Scores on HAM-A
    Description The HAM-A was administered by a site trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-A rating scale. These items include: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. All items are measured on a t5-point scale (0-4). Each HAM-A individual item score can range from 0 to 4 with higher scores indicating higher severity of anxiety questions.
    Time Frame Baseline, Weeks 2, 4, 6, 8

    Outcome Measure Data

    Analysis Population Description
    ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.
    Arm/Group Title Placebo Arm Eszopiclone Low Dose Arm Eszopiclone High Dose Arm
    Arm/Group Description Placebo SEP-225441 (eszopiclone) total daily dose of 0.9 mg SEP-225441 (eszopiclone) total daily dose of 1.5 mg
    Measure Participants 149 146 145
    Anxious Mood-Baseline
    2.8
    (0.5)
    2.8
    (0.5)
    2.8
    (0.5)
    Anxious Mood-Week 2 -Change from baseline
    -0.6
    (0.8)
    -0.5
    (0.7)
    -0.6
    (0.9)
    Anxious Mood-Week 4 - Change from baseline
    -0.8
    (0.9)
    -0.8
    (0.8)
    -0.9
    (1.0)
    Anxious Mood-Week 6 - Change from baseline
    -1.0
    (0.9)
    -0.8
    (0.8)
    -1.0
    (1.0)
    Anxious Mood-Week 8- Change from baseline
    -1.0
    (1.0)
    -0.9
    (0.9)
    -1.1
    (1.1)
    Tension - Baseline
    2.7
    (0.5)
    2.6
    (0.5)
    2.7
    (0.5)
    Tension - Week 2 -Change from baseline
    -0.5
    (0.9)
    -0.4
    (0.7)
    -0.6
    (0.9)
    Tension - Week 4 - Change from baseline
    -0.8
    (1.0)
    -0.6
    (0.9)
    -0.8
    (0.9)
    Tension - Week 6- Change from baseline
    -0.9
    (1.0)
    -0.8
    (1.0)
    -1.0
    (1.0)
    Tension - Week 8- Change from baseline
    -0.9
    (1.0)
    -0.9
    (1.0)
    -1.0
    (1.0)
    Fears- Baseline
    1.1
    (1.1)
    1.2
    (1.0)
    1.0
    (0.9)
    Fears- Week 2- Change from baseline
    -0.3
    (0.9)
    -0.4
    (0.8)
    -0.2
    (0.8)
    Fears- Week 4- Change from baseline
    -0.4
    (0.9)
    -0.5
    (0.9)
    -0.3
    (0.8)
    Fears- Week 6- Change from baseline
    -0.4
    (1.0)
    -0.5
    (0.9)
    -0.4
    (0.9)
    Fears- Week 8- Change from baseline
    -0.5
    (0.9)
    -0.7
    (1.0)
    -0.4
    (0.9)
    Insomnia- Baseline
    2.5
    (0.7)
    2.5
    (0.7)
    2.6
    (0.8)
    Insomnia- Week 2- Change from baseline
    -0.5
    (0.9)
    -0.5
    (1.0)
    -0.8
    (1.0)
    Insomnia- Week 4- Change from baseline
    -0.8
    (1.1)
    -0.8
    (1.0)
    -0.9
    (1.0)
    Insomnia- Week 6- Change from baseline
    -0.8
    (1.0)
    -0.8
    (1.0)
    -0.9
    (1.1)
    insomnia- Week 8- Change from baseline
    -0.9
    (1.1)
    -0.8
    (1.0)
    -1.0
    (1.2)
    Intellectual- Baseline
    2.1
    (0.8)
    2.1
    (0.8)
    2.2
    (0.8)
    Intellectual- Week 2- Change from baseline
    -0.4
    (0.9)
    -0.4
    (0.9)
    -0.5
    (0.9)
    Intellectual- Week 4- Change from baseline
    -0.8
    (1.0)
    -0.6
    (0.9)
    -0.7
    (0.9)
    Intellectual- Week 6- Change from baseline
    -0.7
    (1.1)
    -0.7
    (1.0)
    -0.8
    (1.1)
    Intellectual- Week 8- Change from baseline
    -0.9
    (1.1)
    -0.8
    (1.1)
    -0.9
    (1.1)
    Depressed Mood- Baseline
    1.1
    (0.8)
    1.2
    (0.7)
    1.0
    (0.7)
    Depressed Mood- Week 2- Change from baseline
    -0.3
    (0.8)
    -0.2
    (0.8)
    -0.2
    (0.8)
    Depressed Mood- Week 4- Change in baseline
    -0.4
    (0.9)
    -0.3
    (0.9)
    -0.3
    (0.8)
    Depressed Mood- Week 6- Change from baseline
    -0.3
    (0.9)
    -0.3
    (0.9)
    -0.3
    (0.8)
    Depressed Mood- Week 8- Change from baseline
    -0.4
    (0.9)
    -0.4
    (0.9)
    -0.3
    (0.9)
    Somatic Complaints-Muscular-Baseline
    2.0
    (0.8)
    1.9
    (0.8)
    1.8
    (0.8)
    Somatic Complaints-Muscular-Wk 2-Chg from baseline
    -0.5
    (1.0)
    -0.3
    (0.8)
    -0.5
    (0.8)
    Somatic Complaints-Muscular-Wk 4-Chg from baseline
    -0.7
    (0.9)
    -0.5
    (1.0)
    -0.6
    (0.9)
    Somatic Complaints-Muscular-Wk 6-Chg from baseline
    -0.8
    (1.1)
    -0.7
    (1.1)
    -0.6
    (1.0)
    Somatic Complaints-Muscular-Wk 8-Chg from baseline
    -0.9
    (1.1)
    -0.7
    (1.1)
    -0.7
    (1.1)
    Somatic Complaints-Sensory-Baseline
    1.0
    (0.9)
    1.0
    (0.9)
    1.2
    (0.9)
    Somatic Complaints-Sensory-Wk 2-Chg from baseline
    -0.3
    (0.9)
    -0.2
    (0.8)
    -0.5
    (1.0)
    Somatic Complaints-Sensory-Wk 4-Chg from baseline
    -0.4
    (0.9)
    -0.3
    (1.0)
    1.0
    (0.9)
    Somatic Complaints-Sensory-Wk 6-Chg from baseline
    -0.4
    (0.9)
    -0.4
    (0.9)
    -0.5
    (1.0)
    Somatic Complaints-Sensory-Wk 8-Chg from baseline
    -0.5
    (1.0)
    -0.4
    (1.0)
    -0.5
    (1.0)
    Cardiovascular symptoms-baseline
    1.1
    (1.0)
    1.2
    (1.0)
    1.3
    (1.0)
    Cardiovascular symptoms-Wk 2-Chg. from baseline
    -0.4
    (1.0)
    -0.4
    (0.9)
    -0.5
    (1.0)
    Cardiovascular symptoms-Wk 4-Chg. from baseline
    -0.5
    (1.0)
    -0.7
    (1.0)
    -0.6
    (1.0)
    Cardiovascular symptoms-Wk 6-Chg. from baseline
    -0.6
    (1.0)
    -0.6
    (1.0)
    -0.6
    (1.0)
    Cardiovascular symptoms-Wk 8-Chg. from baseline
    -0.7
    (1.0)
    -0.8
    (1.0)
    -0.7
    (1.1)
    Respiratory Symptoms-Baseline
    1.2
    (0.9)
    1.2
    (0.9)
    1.3
    (0.9)
    Respiratory Symptoms-Wk 2 Change from baseline
    -0.4
    (0.9)
    -0.3
    (0.8)
    -0.4
    (0.9)
    Respiratory Symptoms-Wk 4 Change from baseline
    -0.5
    (0.9)
    -0.5
    (0.9)
    -0.5
    (1.0)
    Respiratory Symptoms-Wk 6 Change from baseline
    -0.6
    (0.9)
    -0.5
    (1.0)
    -0.5
    (1.1)
    Respiratory Symptoms-Wk 8 Change from baseline
    -0.6
    (0.9)
    -0.6
    (0.9)
    -0.7
    (1.0)
    Gastrointestinal Symptoms- Baseline
    1.4
    (1.0)
    1.4
    (1.0)
    1.3
    (0.9)
    Gastrointestinal Symptoms-Wk2-Change from baseline
    -0.3
    (1.1)
    -0.4
    (1.0)
    -0.3
    (1.1)
    Gastrointestinal Symptoms-Wk4-Change from baseline
    -0.5
    (1.0)
    -0.5
    (1.0)
    -0.4
    (1.1)
    Gastrointestinal Symptoms-Wk6-Change from baseline
    -0.6
    (1.0)
    -0.6
    (1.0)
    -0.5
    (1.1)
    Gastrointestinal Symptoms-Wk8-Change from baseline
    -0.6
    (1.0)
    -0.6
    (1.0)
    -0.5
    (1.1)
    Genitourinary Symptoms-Baseline
    1.5
    (1.0)
    1.4
    (1.0)
    1.4
    (1.1)
    Genitourinary Symptoms-Wk 2-Change from baseline
    -0.4
    (1.0)
    -0.2
    (1.0)
    -0.3
    (1.0)
    Genitourinary Symptoms-Wk 4-Change from baseline
    -0.4
    (1.1)
    -0.4
    (1.1)
    -0.4
    (1.1)
    Genitourinary Symptoms-Wk 6-Change from baseline
    -0.5
    (1.1)
    -0.4
    (1.1)
    -0.3
    (1.0)
    Genitourinary Symptoms-Wk 8-Change from baseline
    -0.6
    (1.1)
    -0.5
    (1.1)
    -0.4
    (1.1)
    Autonomic Symptoms-Baseline
    1.8
    (0.9)
    1.8
    (0.8)
    1.8
    (0.8)
    Autonomic Symptoms-Wk 2-Change from baseline
    -0.4
    (0.9)
    -0.3
    (0.9)
    -0.4
    (1.0)
    Autonomic Symptoms-Wk 4-Change from baseline
    -0.5
    (1.0)
    -0.5
    (1.2)
    -0.5
    (0.9)
    Autonomic Symptoms-Wk 6-Change from baseline
    -0.6
    (1.0)
    -0.6
    (1.1)
    -0.6
    (1.0)
    Autonomic Symptoms-Wk 8-Change from baseline
    -0.8
    (1.1)
    -0.7
    (1.2)
    -0.6
    (1.0)
    Behavior at Interview-Baseline
    1.8
    (0.7)
    1.8
    (0.6)
    1.8
    (0.6)
    Behavior at Interview-Wk 2- Change from baseline
    -0.4
    (0.8)
    -0.3
    (0.7)
    -0.4
    (0.8)
    Behavior at Interview-Wk 4- Change from baseline
    -0.6
    (0.7)
    -0.6
    (0.8)
    -0.5
    (0.7)
    Behavior at Interview-Wk 6- Change from baseline
    -0.7
    (0.8)
    -0.7
    (0.8)
    -0.7
    (0.8)
    Behavior at Interview-Wk 8- Change from baseline
    -0.8
    (0.8)
    -0.6
    (0.9)
    -0.7
    (0.9)
    4. Secondary Outcome
    Title Change From Baseline in Clinician Global Impression of Severity (CGI-S)
    Description The CGI-Swas completed by a board certified psychiatrist and represents the clinician's subjective assessment of severity of the subject's anxiety symptoms as assessed by a 7-scale score for a single question, "Considering your total clinical experience with this particular population, how anxious is the subject at this time?" The score was based on the following scale: 1=normal, not at all anxious; 2=borderline anxious; 3=mildly anxious; 4=moderately anxious; 5=markedly anxious; 6=severly anxious; 7=among the most extremely anxious subjects. CGI-S score can range from 0 to 7, with higher values indicating higher severity.
    Time Frame Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF)

    Outcome Measure Data

    Analysis Population Description
    ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.
    Arm/Group Title Placebo Arm Eszopiclone Low Dose Arm Eszopiclone High Dose Arm
    Arm/Group Description Placebo SEP-225441 (eszopiclone) total daily dose of 0.9 mg SEP-225441 (eszopiclone) total daily dose of 1.5 mg
    Measure Participants 149 146 145
    Baseline
    4.4
    (0.5)
    4.3
    (0.5)
    4.4
    (0.6)
    Week 2 - Change from baseline
    -0.6
    (0.9)
    -0.4
    (0.6)
    -0.7
    (0.9)
    Week 4- Change from baseline
    -0.9
    (0.9)
    -0.8
    (0.8)
    -1.0
    (1.1)
    Week 6- Change from baseline
    -1.1
    (1.0)
    -1.0
    (1.0)
    -1.2
    (1.2)
    Week 8- Change from baseline
    -1.3
    (1.1)
    -1.2
    (1.1)
    -1.3
    (1.3)
    5. Secondary Outcome
    Title Clinical Global Impression- Improvement (CGI-I)
    Description CGI-I was completed by a board certified psychiatrist and represented the clinician's subjective assessment of improvement of the subject's anxiety symptoms based on the following question, "Compared to his/her condition at Visit 2, how much has he/she changed?" The score was based on the following scale: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. CGI-I score can range from 0 to 7, with higher values indicating less improvement.
    Time Frame Weeks 2, 4, 6, 8, and 9, based on last observation carried forward (LOCF)

    Outcome Measure Data

    Analysis Population Description
    ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.
    Arm/Group Title Placebo Arm Eszopiclone Low Dose Arm Eszopiclone High Dose Arm
    Arm/Group Description Placebo SEP-225441 (eszopiclone) total daily dose of 0.9 mg SEP-225441 (eszopiclone) total daily dose of 1.5 mg
    Measure Participants 149 146 145
    Week 2
    3.2
    (1.0)
    3.2
    (0.9)
    3.1
    (1.0)
    Week 4
    2.9
    (1.0)
    2.9
    (0.9)
    2.7
    (1.2)
    Week 6
    2.7
    (1.0)
    2.6
    (1.1)
    2.7
    (1.2)
    Week 8
    2.6
    (1.1)
    2.6
    (1.1)
    2.6
    (1.2)
    Week 9
    2.4
    (1.1)
    2.5
    (1.1)
    2.4
    (1.2)
    6. Secondary Outcome
    Title Hamilton Anxiety Scale (HAM-A) 50% Anxiolytic Response
    Description The HAM-A was administered by a site-trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-A rating scale. These items include: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. All items are measured on a 5-point scale (0-4). A 50% anxiolytic response was defined as a 50% or greater reduction from baseline in the HAM-A total score. The Ham-A total score can range from 0 to 56 with higher scores indicating higher severity of anxiety symptoms.
    Time Frame Week 2, 4, 6, 8

    Outcome Measure Data

    Analysis Population Description
    ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.
    Arm/Group Title Placebo Arm Eszopiclone Low Dose Arm Eszopiclone High Dose Arm
    Arm/Group Description Placebo SEP-225441 (eszopiclone) total daily dose of 0.9 mg SEP-225441 (eszopiclone) total daily dose of 1.5 mg
    Measure Participants 149 146 145
    Week 2
    21
    14.1%
    16
    11%
    27
    18.6%
    Week 4
    39
    26.2%
    41
    28.1%
    49
    33.8%
    Week 6
    51
    34.2%
    52
    35.6%
    53
    36.6%
    Week 8
    63
    42.3%
    57
    39%
    66
    45.5%
    7. Secondary Outcome
    Title Hamilton Anxiety Scale (HAM-A) Remission
    Description The HAM-A was administered by a site-trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-A rating scale. These items include: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. All items are measured on a 5-point scale (0-4). Remission was defined as a HAM-A total score of 7 or less. The Ham-A total score can range from 0 to 56 with higher scores indicating higher severity of anxiety symptoms.
    Time Frame Week 2, 4, 6, 8 based on last observation carried forward (LOCF)

    Outcome Measure Data

    Analysis Population Description
    ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.
    Arm/Group Title Placebo Arm Eszopiclone Low Dose Arm Eszopiclone High Dose Arm
    Arm/Group Description Placebo SEP-225441 (eszopiclone) total daily dose of 0.9 mg SEP-225441 (eszopiclone) total daily dose of 1.5 mg
    Measure Participants 149 146 145
    Week 2
    7
    4.7%
    2
    1.4%
    9
    6.2%
    Week 4
    11
    7.4%
    10
    6.8%
    24
    16.6%
    Week 6
    22
    14.8%
    19
    13%
    23
    15.9%
    Week 8
    31
    20.8%
    29
    19.9%
    34
    23.4%
    8. Secondary Outcome
    Title Change From Baseline on Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form
    Description The Q-LES-Q was completed by the subject and assessed quaility of life based on 16 items, each evaluated on a 5-point scale of overall level of enjoyment/satisfaction: 1=very poor; 2=poor; 3=fair; 4=good; 5=very good. The overall percentage score was computed as a sum of items 1 to 14 as expressed as a percentage of the maximum possible score: Overall Percentage Score = Sum [item 1... item 14]-14)/(70-14 ) *100%. Q-LES-Q overall percentage score can range from 0 to 100, with higher values indicating higher quality of life.
    Time Frame Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF)

    Outcome Measure Data

    Analysis Population Description
    ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.
    Arm/Group Title Placebo Arm Eszopiclone Low Dose Arm Eszopiclone High Dose Arm
    Arm/Group Description Placebo SEP-225441 (eszopiclone) total daily dose of 0.9 mg SEP-225441 (eszopiclone) total daily dose of 1.5 mg
    Measure Participants 149 146 145
    Baseline
    52.4
    (14.9)
    52.2
    (13.5)
    52.0
    (14.8)
    Week 2- Change from baseline
    3.1
    (10.6)
    2.1
    (13.2)
    1.5
    (12.1)
    Week 4- Change from baseline
    4.7
    (12.4)
    5.4
    (12.7)
    4.6
    (12.8)
    Week 6- Change from baseline
    5.8
    (13.7)
    6.7
    (13.4)
    5.0
    (13.6)
    Week 8- Change from baseline
    7.0
    (14.8)
    6.8
    (13.2)
    5.8
    (14.6)
    9. Secondary Outcome
    Title Change From Baseline Insomnia Severity Index (ISI) Total Score
    Description The ISI was completed by the subject and is an assessment of the severity of insomnia. The administered extended ISI questionnaire consists of 5 items (containing 7 questions, as item 1 contains 3 questions) comprising the original ISI questionnaire, plus 6 quality of life related items (sleep quality, restedness/refreshness upon arising, daytime fatigue, attention/concentration, relationships and mood disturbances), and 2 items assessing duration and frequency of sleep problems. All items, except for the insomnia duration and frequency questions, are measured on a Likert-type 5-point scale (0-4). ISI total score can range from 0 to 28, with higher scores indicating more severe insomnia.
    Time Frame Baseline, Weeks 2, 4, 6, 8, based on lst observation carried forward (LOCF)

    Outcome Measure Data

    Analysis Population Description
    ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.
    Arm/Group Title Placebo Arm Eszopiclone Low Dose Arm Eszopiclone High Dose Arm
    Arm/Group Description Placebo SEP-225441 (eszopiclone) total daily dose of 0.9 mg SEP-225441 (eszopiclone) total daily dose of 1.5 mg
    Measure Participants 149 146 145
    Baseline
    14.6
    (5.3)
    14.3
    (5.3)
    14.1
    (6.0)
    Week 2- Change from baseline
    -2.4
    (4.4)
    -1.5
    (5.0)
    -2.7
    (5.3)
    Week 4- Change from baseline
    -3.6
    (4.8)
    -3.1
    (5.4)
    -3.4
    (5.3)
    Week 6- Change from baseline
    -4.0
    (5.6)
    -3.6
    (5.5)
    -3.6
    (5.6)
    Week 8- Change from baseline
    -4.3
    (5.6)
    -3.5
    (6.2)
    -4.1
    (5.8)
    10. Secondary Outcome
    Title Change From Baseline Sheehan Disability Scale (SDS)
    Description The SDS was completed by the subject and captured the subject's level of disability. The subject rated the extent to which his or her work, social life or leisure activities, and home life or family responsibilities were impaired by his or her symptoms on a 10-point visual analog scale. SDS total score can range from 0 to 30, with higher scores indicating higher functional impairment.
    Time Frame Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF)

    Outcome Measure Data

    Analysis Population Description
    ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.
    Arm/Group Title Placebo Arm Eszopiclone Low Dose Arm Eszopiclone High Dose Arm
    Arm/Group Description Placebo SEP-225441 (eszopiclone) total daily dose of 0.9 mg SEP-225441 (eszopiclone) total daily dose of 1.5 mg
    Measure Participants 149 146 145
    Baseline
    15.3
    (6.7)
    14.0
    (6.4)
    14.8
    (6.4)
    Week 2- Change from baseline
    -2.5
    (5.5)
    -0.9
    (6.3)
    -2.7
    (5.3)
    Week 4- Change from baseline
    -3.6
    (6.1)
    -2.5
    (6.3)
    -3.5
    (6.1)
    Week 6- Change from baseline
    -4.2
    (6.5)
    -3.4
    (6.3)
    -4.1
    (6.2)
    Week 8- Change from baseline
    -5.1
    (6.6)
    -4.1
    (6.5)
    -4.4
    (6.2)
    11. Secondary Outcome
    Title Change From Baseline Epworth Sleepiness Scale (ESS)
    Description ESS was completed by the subject and assessed daytime sedation based on 8 items, each presenting a situation for which the subject needed to evaluate how likely he/she is to doze off or fall asleep in contrast to feeling just tired. Each item was evaluated on the following scale: 0 = would never doze; 1 = slight chance of dozing; 2 = moderate chance of dozing; 3 = high chance of dozing. ESS total score can range from 0 to 24, with higher scores indicating higher levels of daytime sleepiness.
    Time Frame Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF)

    Outcome Measure Data

    Analysis Population Description
    ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.
    Arm/Group Title Placebo Arm Eszopiclone Low Dose Arm Eszopiclone High Dose Arm
    Arm/Group Description Placebo SEP-225441 (eszopiclone) total daily dose of 0.9 mg SEP-225441 (eszopiclone) total daily dose of 1.5 mg
    Measure Participants 149 146 145
    Baseline
    7.4
    (4.5)
    8.4
    (4.5)
    8.5
    (4.8)
    Week 2- Change from baseline
    -0.1
    (4.0)
    -0.5
    (3.8)
    -0.4
    (3.6)
    Week 4- Change from baseline
    -0.2
    (4.6)
    -1.0
    (4.1)
    -0.7
    (4.5)
    Week 6- Change from baseline
    -0.6
    (4.0)
    -1.3
    (4.0)
    -0.9
    (4.5)
    Week 8- Change from baseline
    -0.8
    (4.0)
    -1.4
    (4.2)
    -1.3
    (4.5)

    Adverse Events

    Time Frame 10 weeks
    Adverse Event Reporting Description
    Arm/Group Title Placebo Arm Eszopiclone Low Dose Arm Eszopiclone High Dose Arm
    Arm/Group Description Placebo SEP-225441 (eszopiclone) total daily dose of 0.9 mg SEP-225441 (eszopiclone) total daily dose of 1.5 mg
    All Cause Mortality
    Placebo Arm Eszopiclone Low Dose Arm Eszopiclone High Dose Arm
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Placebo Arm Eszopiclone Low Dose Arm Eszopiclone High Dose Arm
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/149 (0%) 3/146 (2.1%) 0/145 (0%)
    Infections and infestations
    Amniotic Cavity Infection 0/149 (0%) 0 1/146 (0.7%) 1 0/145 (0%) 0
    Injury, poisoning and procedural complications
    Traumatic Brain Injury 0/149 (0%) 0 1/146 (0.7%) 1 0/145 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon Cancer 0/149 (0%) 0 1/146 (0.7%) 1 0/145 (0%) 0
    Pregnancy, puerperium and perinatal conditions
    Abortion Spontaneous 0/149 (0%) 0 1/146 (0.7%) 1 0/145 (0%) 0
    Psychiatric disorders
    Self Injurious Behavior 0/149 (0%) 0 1/146 (0.7%) 1 0/145 (0%) 0
    Other (Not Including Serious) Adverse Events
    Placebo Arm Eszopiclone Low Dose Arm Eszopiclone High Dose Arm
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 104/149 (69.8%) 111/146 (76%) 116/145 (80%)
    Gastrointestinal disorders
    Nausea 14/149 (9.4%) 19 7/146 (4.8%) 8 18/145 (12.4%) 21
    Diarrhoea 11/149 (7.4%) 11 5/146 (3.4%) 5 13/145 (9%) 16
    Dry Mouth 6/149 (4%) 7 8/146 (5.5%) 8 12/145 (8.3%) 12
    Abdominal Pain Upper 10/149 (6.7%) 11 9/146 (6.2%) 12 14/145 (9.7%) 20
    General disorders
    Fatigue 12/149 (8.1%) 14 12/146 (8.2%) 12 4/145 (2.8%) 4
    Infections and infestations
    Upper Respiratory Tract Infection 6/149 (4%) 7 12/146 (8.2%) 12 4/145 (2.8%) 4
    Nasaopharyngitis 5/149 (3.4%) 6 6/146 (4.1%) 6 8/145 (5.5%) 9
    Musculoskeletal and connective tissue disorders
    Back Pain 3/149 (2%) 3 10/146 (6.8%) 11 4/145 (2.8%) 5
    Nervous system disorders
    Headache 27/149 (18.1%) 47 26/146 (17.8%) 44 24/145 (16.6%) 41
    Dysgeusia 3/149 (2%) 3 10/146 (6.8%) 16 35/145 (24.1%) 37
    Dizziness 6/149 (4%) 7 11/146 (7.5%) 15 16/145 (11%) 20
    Somnolence 7/149 (4.7%) 7 8/146 (5.5%) 8 10/145 (6.9%) 11
    Respiratory, thoracic and mediastinal disorders
    Pharyngolaryngeal Pain 3/149 (2%) 3 8/146 (5.5%) 8 1/145 (0.7%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish

    Results Point of Contact

    Name/Title Eszopiclone Medical Director
    Organization Sunovion
    Phone 866-503-7813
    Email clinicaltrialdisclosure@sunovion.com
    Responsible Party:
    Sunovion
    ClinicalTrials.gov Identifier:
    NCT00616655
    Other Study ID Numbers:
    • 194-027
    First Posted:
    Feb 15, 2008
    Last Update Posted:
    Apr 8, 2016
    Last Verified:
    Mar 1, 2016