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Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia Followed by Optional Extension up to 1 Year | Clinical Trials | Clareo Health

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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

NCT00253903•Sanofi

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Out patients
•Each patient must have primary insomnia in accordance with DSM-IV-TR-Axis I criteria
•Based on patient's information, the patient has spent at least 6.5 hours and not more than 9.0 hours, in bed, each night, over the preceding two weeks.
•Based on patient's information, the patient must complain of at least one hour of wakefulness after sleep onset for at least 3 nights per week over the preceding month
•Patient must report impact daytime functioning associated with sleep maintenance insomnia as measured by question 3 of Insomnia Severity Index at screening visit and randomization visit.

Exclusion Criteria

•Females who are lactating or pregnant
•Woman of childbearing potential with a positive serum beta human chorionic gonadotropin pregnancy test at screening and not using an acceptable form of contraception
•Patients presenting with acute or chronic pain resulting in insomnia
•Patients with history of epilepsy or seizures
•Consumption of xanthine containing beverage (i.e. tea, coffee, or cola) comprising more than 5 glasses/day
•Evidence of any clinically significant, severe, or unstable acute or chronically progressive medical or surgical disorder which may affect patient safety
•BMI \>32
•Acute or chronic pain resulting in insomnia
•Patients with current psychiatric disorders according to DSM-IV-TR criteria, mental retardation, or dementia
•Clinically significant and abnormal EKG (QTc interval \>500 msec)
+14 more criteria

Locations (14)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Sanofi-Aventis Administrative Office

Buenos Aires, Argentina

Sanofi-Aventis Administrative Office

Macquarie Park, New South Wales, Australia

Sanofi-Aventis Administrative Office

Vienna, Austria

Sanofi-Aventis Administrative Office

Laval, Quebec, Canada

Sanofi-Aventis Administrative Office

Santiago, Chile

Sanofi-Aventis Administrative Office

Prague, Czechia

Sanofi-Aventis Administrative Office

Helsinki, Finland

Sanofi-Aventis Administrative Office

Paris, France

Sanofi-Aventis Administrative Office

Berlin, Germany

Key Dates

Start Date

November 1, 2005

Primary Completion Date

November 1, 2007

Completion Date

September 1, 2008

Last Updated

November 30, 2010

Enrollment

1,155

ACTUAL participants

Conditions

Sleep Initiation and Maintenance DisordersInsomnia

Interventions

eplivanserin (SR46349)

DRUG

placebo

DRUG

Sponsors

Lead Sponsor

Sanofi

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 30, 2010Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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