NCT00805350CompletedPhase 3
Efficacy and Safety of Eplivanserin 5mg/Day in Insomnia Characterized by Sleep Maintenance Difficulties: a 6-week, Randomized, Double-blind, Placebo-controlled, Polysomnography Study.
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 637
- Locations
- 1
- Primary Endpoint
- Change from baseline of mean PSG-NAW on N41/N42
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of primary insomnia based on DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revisions) criteria
Exclusion 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.
Arms & Interventions
Eplivanserin
Experimental
Eplivanserin 5 mg/day
Intervention: Eplivanserin (Drug)
Placebo
Placebo Comparator
Placebo of Eplivanserin 5 mg/day
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change from baseline of mean PSG-NAW on N41/N42
Time Frame: 6 weeks
Change from baseline of mean PSG-WASO on N41/N42
Time Frame: 6 weeks
Secondary Outcomes
- Patient-reported sleep parameters(6 weeks)
- Patient Global impression (PGI)(6 weeks)
- SF-36 Health Survey(6 weeks)
- 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)
- Other PSG sleep parameters: PSG-TST, PSG-SE (TST/Time in Bed), PSG-LPS(6 weeks)
Investigators
Study Sites (1)
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