Efficacy and Safety of Eplivanserin 5mg/Day in Insomnia Characterized by Sleep Maintenance Difficulties
- Registration Number
- NCT00805350
- Lead Sponsor
- Sanofi
- Brief Summary
Primary objective:
- To assess the efficacy of eplivanserin 5mg/day in comparison to placebo after 6 weeks of treatment on sleep maintenance of insomniac patients, as measured by Polysomnography Wake Time After Sleep Onset (PSG-WASO) and Polysomnography Number of Awakenings (PSG-NAW).
Secondary objectives:
* To evaluate the effects of eplivanserin 5mg/day as compared to placebo after 6 weeks of treatment on other sleep parameters measured by PSG recordings (Total Sleep Time - PSG-TST, Sleep Efficiency - PSG-SE, Latency to Persistent Sleep - PSG-LPS) and reported by patients (Wake Time After Sleep Onset - pr-WASO, Number of Awakenings - pr-NAW, Total Sleep Time - pr-TST, Quality of Sleep - QoS and Refreshing Quality of Sleep - RqoS).
* To evaluate the effects of eplivanserin 5mg/day on sleep architecture compared to placebo.
* To evaluate the effect of eplivanserin 5mg/day on daytime functioning using the Sleep Impact Scale (SIS), as compared with placebo after 6 weeks of treatment.
* To evaluate patient's impression of treatment effects using the Patient's Global Impression questionnaire.
* To evaluate the potential for next-day residual effects (using patient's morning questionnaire and psychometric tests) with eplivanserin 5mg/day as compared to placebo.
* To evaluate the potential for rebound insomnia following abrupt discontinuation of eplivanserin 5mg/day in comparison with placebo.
* To evaluate the effect of eplivanserin, compared to placebo, on the quality of life of patients with primary insomnia using the SF-36 Health Survey.
* To evaluate the clinical safety and tolerability of eplivanserin 5mg/day compared to placebo.
- Detailed Description
Randomized, double-blind, placebo, controlled study with 2 parallel groups Duration of treatment : 6 weeks
Duration of observation: 9 weeks
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 637
- Diagnosis of primary insomnia based on DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revisions) criteria
- Inpatients.
- Mean screening PSG-WASO for screening night 1+ screening night 2 < 45 mn, or screening night with PSG-WASO < 30 mn.
- Mean screening PSG-TST for screening night 1 + screening night 2 ≥7 hours or ≤3hours.
- Mean screening PSG-LPS for screening night 1+ screening night 2 > 30 mn.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Eplivanserin Eplivanserin Eplivanserin 5 mg/day Placebo Placebo Placebo of Eplivanserin 5 mg/day
- Primary Outcome Measures
Name Time Method Change from baseline of mean PSG-WASO on N41/N42 6 weeks Change from baseline of mean PSG-NAW on N41/N42 6 weeks
- Secondary Outcome Measures
Name Time Method sleep architecture: percentage of time spent in each sleep stage (1, 2, 3-4/SWS, REM), shift to stage 1, shift to wake, stage 1 + WASO, [stages 3&4]/[stage 1 + WASO]). 6 weeks Sleep Impact Scale (SIS) 6 weeks SF-36 Health Survey 6 weeks Other PSG sleep parameters: PSG-TST, PSG-SE (TST/Time in Bed), PSG-LPS 6 weeks Patient-reported sleep parameters 6 weeks Patient Global impression (PGI) 6 weeks
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇵🇱Warszawa, Poland