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

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 Followed by an Open Treatment Phase Extension With Eplivanserin for a 40-week Period

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

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 ;

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 NCT00253903
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 3
Start date November 2005
Completion date September 2008
View Details
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