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6-Month Chronic Efficacy & Safety Study of Eszopiclone in Adult Subjects With Primary Insomnia

Sponsor
Sunovion (Industry)
Overall Status
Completed
CT.gov ID
NCT00352144
Collaborator
(none)
830
Enrollment
58
Locations
2
Arms
12
Duration (Months)
14.3
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the long-term efficacy of eszopiclone administered for up to 6 months in subjects with primary insomnia on subjective sleep measures, compared to placebo.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

This is a double blind, randomized (2:1; eszopiclone : placebo), placebo-controlled, multicenter, study of eszopiclone in subjects with primary insomnia. The study will involve up to 9 visits and subject participation will be approximately 224 days. After meeting all screening criteria, subjects will be randomized to either eszopiclone 3 mg QD or placebo. 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 :
830 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Six-Month, Chronic Efficacy and Safety Study of Eszopiclone in Adult Subjects With Primary Insomnia: A Randomized Double-Blind, Placebo-Controlled Study
Study Start Date :
Oct 1, 2003
Actual Primary Completion Date :
Oct 1, 2004
Actual Study Completion Date :
Oct 1, 2004

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

eszopiclone 3 mg tablet

Drug: Eszopiclone
Eszopiclone 3 mg
Other Names:
  • Lunesta
  • S-Zopiclone

    		•
    Placebo Comparator: 2

    Placebo tablet

    Drug: Placebo
    Placebo tablet

    Outcome Measures

    Primary Outcome Measures

    1. Average of Subjective Sleep Latency [Days -14, 1, 30, 60, 90, 120, 150, 180]

    Secondary Outcome Measures

    1. Average of Total Sleep Time (TST) and Wake Time After Sleep Onset (WASO) [Days -14, 1, 30, 60, 90, 120, 150, 180]

    2. SF-36 [Days 1, 30, 90, 180]

    3. Work Limitations Questionnaire (WLQ) [Days 1, 30, 90, 180]

    4. Insomnia Severity Index (ISI) [Days 1, 30, 90, 180]

    5. Fatigue Severity Scale (FSS) [Days 1, 30, 90, 180]

    6. Epworth Sleepiness Scale (ESS) [Days 1, 30, 60, 90, 120, 150, 180]

    7. Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) [Day 180]

    8. Healthcare Utilization Questionnaire (HUQ) [Days 1, 30, 60, 90, 120, 150, 180]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria

    • Subject meets DSM-IV criteria for primary insomnia and reports sleeping no more than 6.5 hours per night and/or taking more than 30 minutes each night to fall asleep for at least one month prior to screening.

    • Male and female subjects must be between 21 and 64 years of age, inclusive, at the time of consent.

    • Female subjects of childbearing potential must sign the Women of Childbearing Potential Addendum to the informed consent form. Females considered not of childbearing potential must be surgically sterile or greater than one-year post menopausal, defined as a complete cessation of menstruation for at least one year.

    • Subject must be in general good health, based on screening physical examination (including brief neurological examination), medical history, 12-lead ECG, and clinical laboratory values (hematology, serum chemistry and urinalysis).

    Exclusion Criteria

    • Subject has any clinically significant unstable medical abnormality, chronic disease, or a history of a clinically significant abnormality of the cardiovascular, respiratory, hepatic, or renal systems.

    • Subject has a history of cancer within the past 5 years, or current malignancy except for non melanomatous skin cancer.

    • Subject has a psychiatric diagnosis with psychosis, dementia or delirium. Subjects with Sexual and Gender Identity Disorders or other non-psychotic disorders will be considered on a case-by-case basis.

    • Subject has one of the following Personality Disorders: schizotypal, schizoid, or borderline personality disorder.

    • Subject has difficulties in sleep initiation or maintenance associated with known medical diagnosis (e.g. sleep apnea, restless leg syndrome (RLS), or periodic leg movement syndrome (PLMS), or has any condition that has or may affect sleep (e.g., chronic pain, BPH, etc.).

    • Subject has participated in a previous eszopiclone clinical trial.

    • Subject has a known sensitivity to racemic zopiclone, any benzodiazepine, any sedative hypnotic, any substance that is contained in the formulation, or has been hospitalized for any allergic conditions (e.g. recurrent dermatitis, drug hypersensitivity, drug allergy, etc.).

    • Subject has history of substance abuse in the past 10 years or substance dependence at any time or positive urine drug test at screening .

    • Subject tests positive at screening for hepatitis B surface antigen, hepatitis C antibody or has a history of a positive result.

    • Subject is known to be seropositive for HIV.

    • Female subjects who are pregnant, lactating or within 6 months post partum.

    • Subject self-reports consumption of more than two alcoholic beverages daily, 14 or more alcoholic beverages weekly, or five or more alcoholic beverages on any given day.

    • Subject has taken any psychotropic medications or other medications known to affect sleep within the 3 days prior to screening visit or is anticipated to need any of these types of medications during double-blind treatment .

    • Subject has participated in any investigational study within 30 days prior to screening.

    • Subject has taken herbal supplements, purported to have central nervous system effects,(tablets, powders, extracts or tinctures) or combination products with herbs or melatonin within 14 days prior to screening or St. John's Wort within 30 days prior to screening.

    • Subject is a rotating or third/night shift worker.

    • Subject is a staff member or relative of a staff member.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Birmingham Alabama United States
    2 Huntsville Alabama United States
    3 Phoenix Arizona United States
    4 Scottsdale Arizona United States
    5 Anaheim California United States
    6 Irvine California United States
    7 Oakland California United States
    8 Redlands California United States
    9 San Diego California United States
    10 Aurora Colorado United States
    11 Denver Colorado United States
    12 Longmont Colorado United States
    13 Pueblo Colorado United States
    14 Clearwater Florida United States
    15 Jacksonville Florida United States
    16 Jupiter Florida United States
    17 Naples Florida United States
    18 Orlando Florida United States
    19 Pembroke Pines Florida United States
    20 Pinellas Park Florida United States
    21 St. Petersburg Florida United States
    22 Tampa Florida United States
    23 Atlanta Georgia United States
    24 Blairsville Georgia United States
    25 Chicago Illinois United States
    26 Elk Grove Village Illinois United States
    27 Northbrook Illinois United States
    28 Evansville Indiana United States
    29 Olathe Kansas United States
    30 Prairie Village Kansas United States
    31 Chevy Chase Maryland United States
    32 Frederick Maryland United States
    33 Newton Massachusetts United States
    34 Kansas City Missouri United States
    35 St. Louis Missouri United States
    36 Lincoln Nebraska United States
    37 Las Vegas Nevada United States
    38 Hamilton New Jersey United States
    39 New York New York United States
    40 Cary North Carolina United States
    41 Cincinatti Ohio United States
    42 Cleveland Ohio United States
    43 Columbus Ohio United States
    44 Mogadore Ohio United States
    45 Oklahoma City Oklahoma United States
    46 Eugene Oregon United States
    47 Bala Cynwyd Pennsylvania United States
    48 Anderson South Carolina United States
    49 Columbia South Carolina United States
    50 Austin Texas United States
    51 Dallas Texas United States
    52 Houston Texas United States
    53 Jackson Texas United States
    54 Lubbock Texas United States
    55 Plano Texas United States
    56 San Antonio Texas United States
    57 Brown Deer Wisconsin United States
    58 Madison Wisconsin United States

    Sponsors and Collaborators

    • Sunovion

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sunovion
    ClinicalTrials.gov Identifier:
    NCT00352144
    Other Study ID Numbers:
    • 190-050
    First Posted:
    Jul 14, 2006
    Last Update Posted:
    Feb 22, 2012
    Last Verified:
    Feb 1, 2012
    Additional relevant MeSH terms:
    Sleep Initiation and Maintenance Disorders
    Eszopiclone
    Zopiclone

    Study Results

    No Results Posted as of Feb 22, 2012