- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00308503
Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia (EPOCH)
November 29, 2010 updated by: Sanofi
Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia: A 6 Week, Multicenter, Randomized, Double -Blind, Placebo-controlled Study
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
608
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New South Wales
-
Macquarie Park, New South Wales, Australia
- Sanofi-Aventis
-
-
-
-
-
Laval, Canada
- Sanofi-Aventis
-
-
-
-
New York
-
Bridgewater, New York, United States, 08807
- Sanofi-Aventis
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
|
oral administration
|
Experimental: 1
5 mg/day
|
oral administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline of night polysomnography Wake Time After Sleep Onset (PSG WASO)
Time Frame: week 6
|
week 6
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in general productivity domain of the FOSQ (Functional Outcome of Sleep Questionnaire)
Time Frame: week 6
|
week 6
|
Change from baseline in patient reported wake after sleep onset (pr-WASO)
Time Frame: week 6
|
week 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2006
Primary Completion (Actual)
August 1, 2007
Study Completion (Actual)
August 1, 2007
Study Registration Dates
First Submitted
March 28, 2006
First Submitted That Met QC Criteria
March 28, 2006
First Posted (Estimate)
March 29, 2006
Study Record Updates
Last Update Posted (Estimate)
November 30, 2010
Last Update Submitted That Met QC Criteria
November 29, 2010
Last Verified
November 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Sleep Initiation and Maintenance Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Serotonin Agents
- Serotonin Antagonists
- SR 46349B
Other Study ID Numbers
- EFC6220
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Insomnia
-
Leiden UniversityBioClock Consortium; Caring UniveristiesCompleted
-
National Science Council, TaiwanCompleted
-
Sunshine Lake Pharma Co., Ltd.Unknown
-
Pfizer's Upjohn has merged with Mylan to form Viatris...Completed
-
Massachusetts General HospitalNational Institutes of Health (NIH)Completed
-
IpsenCompletedThe Effectiveness of Circadin in Improving Quality of Sleep in Patients Aged 55 or Over (QUALISLEEP)InsomniaRussian Federation
-
Charite University, Berlin, GermanyCompleted
-
Roxane LaboratoriesCompleted
-
Butler HospitalSunovionCompleted
Clinical Trials on placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States