NCT00253903

Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia Followed by Optional Extension up to 1 Year

Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia: a 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study Followed by an Open Treatment Phase Extension With Eplivanserin for a 40-week Period

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,155 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to assess efficacy and safety of eplivanserin in the population of patients complaining of sleep maintenance insomnia. The patients suffering from that condition frequently wake up during the night, their sleep is nonrestorative and they suffer from a significant distress or impairment in their daily activities consecutive to insomnia.

Detailed description

The study is being conducted worldwide. It consists of 4 segments: * Segment A: 7-day run-in (screening) * Segment B: 12-week double blind treatment * Segment C: 40-week open treatment extension * Segment D: 2-week run-out period

Conditions

• Sleep Initiation and Maintenance Disorders
• Insomnia

Interventions

Type	Name	Description
DRUG	eplivanserin (SR46349)	oral administration
DRUG	placebo	oral administration

Timeline

• Start date: 2005-11-01
• Primary completion: 2007-11-01
• Completion: 2008-09-01
• First posted: 2005-11-15
• Last updated: 2010-11-30

Locations

14 sites across 14 countries: United States, Argentina, Australia, Austria, Canada, Chile, Czechia, Finland, France, Germany, Mexico, Netherlands, Spain, United Kingdom