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Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia — GEMS  

Insomnia Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

  • Insomnia
  • Sleep Initiation and Maintenance Disorders
Clinical Trial Details
NCT number NCT00253968
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 3
Start date November 2005
Completion date January 2008
View Details
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