NCT00253968

Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia

Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia: a 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 967 (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

12 weeks for each patient (double-blind period) + 1 week of run-in (placebo), and 2 weeks of run-out (placebo) Total Duration of observation: 15 weeks for each patient

Conditions

• Sleep Initiation and Maintenance Disorders
• Insomnia

Interventions

Type	Name	Description
DRUG	Eplivanserin	oral administration
DRUG	placebo	oral administration

Timeline

• Start date: 2005-11-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2005-11-15
• Last updated: 2016-03-01

Locations

12 sites across 12 countries: United States, Argentina, Australia, Canada, Chile, Czechia, France, Germany, Mexico, Netherlands, Spain, United Kingdom