6-Month Chronic Efficacy & Safety Study of Eszopiclone in Adult Subjects With Primary Insomnia
- Registration Number
- NCT00352144
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 830
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Placebo Placebo tablet 1 Eszopiclone eszopiclone 3 mg tablet
- Primary Outcome Measures
Name Time Method Average of Subjective Sleep Latency Days -14, 1, 30, 60, 90, 120, 150, 180
- Secondary Outcome Measures
Name Time Method Average of Total Sleep Time (TST) and Wake Time After Sleep Onset (WASO) Days -14, 1, 30, 60, 90, 120, 150, 180 SF-36 Days 1, 30, 90, 180 Work Limitations Questionnaire (WLQ) Days 1, 30, 90, 180 Insomnia Severity Index (ISI) Days 1, 30, 90, 180 Fatigue Severity Scale (FSS) Days 1, 30, 90, 180 Epworth Sleepiness Scale (ESS) Days 1, 30, 60, 90, 120, 150, 180 Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Day 180 Healthcare Utilization Questionnaire (HUQ) Days 1, 30, 60, 90, 120, 150, 180