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NCT00805350 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Eplivanserin 5mg/Day in Insomnia Characterized by Sleep Maintenance Difficulties
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 637
- Enrollment target
NCT00805350 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 637 participants.
The verdict
NCT00805350, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 637 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Eplivanserin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 637 participants |
| Start Date | 2008-12 |
| Est. Completion | 2009-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00805350
The ClinicalTrials.gov registry entry for NCT00805350 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 637 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00805350 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00805350 about?
NCT00805350 is a clinical study titled "Efficacy and Safety of Eplivanserin 5mg/Day in Insomnia Characterized by Sleep Maintenance Difficulties". 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 o...
What is the current status of trial NCT00805350?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 637 participants. The study started on 2008-12. Estimated completion is 2009-06.
What interventions are being tested in trial NCT00805350?
The interventions under investigation include: Placebo (DRUG), Eplivanserin (DRUG).
Who is sponsoring clinical trial NCT00805350?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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