Status:
COMPLETED
Efficacy and Safety of Eplivanserin 5mg/Day in Insomnia Characterized by Sleep Maintenance Difficulties
Lead Sponsor:
Sanofi
Conditions:
Primary Insomnia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 Wak...
Detailed Description
Randomized, double-blind, placebo, controlled study with 2 parallel groups Duration of treatment : 6 weeks Duration of observation: 9 weeks
Eligibility Criteria
Inclusion
- Diagnosis of primary insomnia based on DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revisions) criteria
Exclusion
- Inpatients.
- Mean screening PSG-WASO for screening night 1+ screening night 2 \< 45 mn, or screening night with PSG-WASO \< 30 mn.
- Mean screening PSG-TST for screening night 1 + screening night 2 ≥7 hours or ≤3hours.
- Mean screening PSG-LPS for screening night 1+ screening night 2 \> 30 mn.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
637 Patients enrolled
Trial Details
Trial ID
NCT00805350
Start Date
December 1 2008
End Date
June 1 2009
Last Update
March 7 2016
Active Locations (7)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Vienna, Austria
3
Sanofi-Aventis Administrative Office
Laval, Canada
4
Sanofi-Aventis Administrative Office
Paris, France