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

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ClinicalTrials.gov Identifier: NCT00308503
Recruitment Status : Completed
First Posted : March 29, 2006
Last Update Posted : November 30, 2010
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Sleep Initiation and Maintenance Disorders Insomnia Drug: eplivanserin (SR46349) Drug: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 608 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : February 2006
Primary Completion Date : August 2007
Study Completion Date : August 2007

Arm Intervention/treatment
Experimental: 1
5 mg/day
Drug: eplivanserin (SR46349)
oral administration
Placebo Comparator: 2 Drug: placebo
oral administration

Primary Outcome Measures :
  1. Change from baseline of night polysomnography Wake Time After Sleep Onset (PSG WASO) [ Time Frame: week 6 ]

Secondary Outcome Measures :
  1. Change from baseline in general productivity domain of the FOSQ (Functional Outcome of Sleep Questionnaire) [ Time Frame: week 6 ]
  2. Change from baseline in patient reported wake after sleep onset (pr-WASO) [ Time Frame: week 6 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00308503

United States, New York
Bridgewater, New York, United States, 08807
Australia, New South Wales
Macquarie Park, New South Wales, Australia
Laval, Canada
Sponsors and Collaborators
Study Director: ICD CSD Sanofi

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00308503     History of Changes
Other Study ID Numbers: EFC6220
First Posted: March 29, 2006    Key Record Dates
Last Update Posted: November 30, 2010
Last Verified: November 2010

Keywords provided by Sanofi:
Primary Insomnia
Sleep Maintenance Insomnia

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
SR 46349B
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Physiological Effects of Drugs