Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia (EPOCH)

This study has been completed.

Sponsor:

Information provided by:

Sanofi

ClinicalTrials.gov Identifier:

NCT00308503

First received: March 28, 2006

Last updated: November 29, 2010

Last verified: November 2010

History of Changes

Purpose

The aim of the study is to confirm the efficacy of eplivanserin 5mg/day on sleep maintenance of patients with primary insomnia using night polysomnography recordings over a 6-week treatment period corresponding to a stabilization of improvement of sleep.

Condition	Intervention	Phase
Sleep Initiation and Maintenance Disorders Insomnia	Drug: eplivanserin (SR46349) Drug: placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia: A 6 Week, Multicenter, Randomized, Double -Blind, Placebo-controlled Study

Resource links provided by NLM:

MedlinePlus related topics: Insomnia

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:

Change from baseline of night polysomnography Wake Time After Sleep Onset (PSG WASO) [ Time Frame: week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in general productivity domain of the FOSQ (Functional Outcome of Sleep Questionnaire) [ Time Frame: week 6 ] [ Designated as safety issue: No ]
Change from baseline in patient reported wake after sleep onset (pr-WASO) [ Time Frame: week 6 ] [ Designated as safety issue: No ]

Enrollment:	608
Study Start Date:	February 2006
Study Completion Date:	August 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 5 mg/day	Drug: eplivanserin (SR46349) oral administration
Placebo Comparator: 2	Drug: placebo oral administration

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of primary insomnia based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for at least one month preceding the study visit.
Disturbance of sleep maintenance:
- Based on patient' s information:
  - Patient has spent at least 6.5 hours and not more than 9.0 hours, in bed, each night, over the preceding two weeks,
  - 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 on daytime functioning associated with sleep maintenance insomnia

Inclusion will be based on the nocturnal polysomnography (NPSG) recordings performed at the sleep laboratory during the two screening nights.

Exclusion Criteria:

Females who are lactating or who are pregnant, or of childbearing potential not using an acceptable form of contraception
Patients presenting with acute or chronic pain resulting in insomnia
Patients with current psychiatric disturbances
Body mass index > 32
Evidence of any clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder, or any condition that may interfere with the absorption, metabolism, distribution or excretion of the study drug, or may affect patient safety
Clinically significant and abnormal electrocardiogram (ECG) (including QTc B > 500ms),
A positive test for hepatitis B (hepatitis B surface [HBs] antigens) or C (hepatitis C virus [HCV] antibodies)
Positive qualitative urine drug screen at screening
Consumption of xanthine-containing beverages (i.e. tea, coffee, or cola) comprising usually more than 5 cups or glasses per day
Use of any over-the-counter or prescription sleep medication, or of any substance with psychotropic effects or properties known to affect sleep/wake, within one week or five half-lives (whichever is longer), prior to screening
Night shift workers, and individuals who nap 3 or more times per week over the preceding month
Based on medical history and/or NPSG:
- primary hypersomnia
- narcolepsy
- breathing-related sleep disorder (apnea-hypopnea index > 10/hour of sleep)
- circadian rhythm sleep disorder
- parasomnia (e.g. somnambulism)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00308503

Locations

United States, New York
Sanofi-Aventis
Bridgewater, New York, United States, 08807
Australia, New South Wales
Sanofi-Aventis
Macquarie Park, New South Wales, Australia
Canada
Sanofi-Aventis
Laval, Canada

Sponsors and Collaborators

Sanofi

Investigators

Study Director:

ICD CSD

Sanofi

More Information

No publications provided

Responsible Party:	ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00308503 History of Changes
Other Study ID Numbers:	EFC6220
Study First Received:	March 28, 2006
Last Updated:	November 29, 2010
Health Authority:	United States: Food and Drug Administration Canada: Ethics Review Committee Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Sanofi:

Primary Insomnia
Sleep Maintenance Insomnia
Awakening

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
SR 46349B
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013

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