Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia (GEMS)

February 2, 2016 updated by: Sanofi

Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia: a 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

12 weeks for each patient (double-blind period) + 1 week of run-in (placebo), and 2 weeks of run-out (placebo)

Total Duration of observation: 15 weeks for each patient

Study Type

Interventional

Enrollment (Actual)

967

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

  • Argentina
      • Buenos Aires, Argentina
        • Sanofi-Aventis Administrative Office
  • Australia
      • Macquarie Park, Australia
        • Sanofi-Aventis Administrative Office
  • Canada
      • Laval, Canada
        • Sanofi-Aventis Administrative Office
  • Chile
      • Santiago, Chile
        • Sanofi-Aventis Administrative Office
  • Czech Republic
      • Praha, Czech Republic
        • Sanofi-Aventis Administrative Office
  • France
      • Paris, France
        • Sanofi-Aventis Administrative Office
  • Germany
      • Berlin, Germany
        • Sanofi-Aventis Administrative Office
  • Mexico
      • Mexico, Mexico
        • Sanofi-Aventis Administrative Office
  • Netherlands
      • Gouda, Netherlands
        • Sanofi-Aventis Administrative Office
  • Spain
      • Barcelona, Spain
        • Sanofi-Aventis Administrative Office
  • United Kingdom
      • Guildford, United Kingdom
        • Sanofi-Aventis Administrative Office
  • United States
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Sanofi-Aventis Administrative Office

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:

  • Out patients
  • Each patient must have primary insomnia in accordance with DSM-IV-TR-Axis I (Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition-Text Revision) criteria
  • 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)
  • Positive for hepatitis B or C
  • Serious head injury or stroke within 1 year
  • Use of OTC (over-the-counter) medications such as valerian root, kava, melatonin, St. John's Wort, or alluna; prescription sleep medications or anxiolytics within 1 week or 5 half-lives
  • Participation in another trial within two month before the screening visit
  • Use of any substance with psychotropic effects or properties known to affect sleep/wake
  • Unable to complete the study questionnaires
  • Night shift workers, and individuals who nap 3 or more times per week over the preceding month

  • History of:

    • Primary hypersomnia
    • Narcolepsy
    • Breathing-related sleep disorder (such as sleep apnea)
    • Circadian rhythm sleep disorder
    • Parasomnia (somnambulism)
    • Dyssomnia (such as periodic leg movements)

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
Experimental: Eplivanserin
Eplivanserin 5 mg/day
Drug: Eplivanserin
oral administration
Other Names:
  • (SR46349)
Placebo Comparator: Placebo
Placebo of Eplivanserin 5 mg /day
Drug: placebo
oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline of the mean pr-WASO (wake time after sleep onset using patient's sleep questionnaire)
Time Frame: at week 12
at week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline of the mean of the FOSQ (Functional Outcome of Sleep Questionnaire) items 1 and 2 (concentration/memory)
Time Frame: at week 12
at week 12
Change from baseline of the mean of the FOSQ items 4 and 10 (hobby/work)
Time Frame: at week 12
at week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

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

November 1, 2005

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

November 14, 2005

First Submitted That Met QC Criteria

November 14, 2005

First Posted (Estimate)

November 15, 2005

Study Record Updates

Last Update Posted (Estimate)

March 1, 2016

Last Update Submitted That Met QC Criteria

February 2, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LTE6217
  • 2005-003080-23 (EudraCT Number)

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.

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