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

This study has been completed.
Information provided by (Responsible Party):
Sanofi Identifier:
First received: November 14, 2005
Last updated: February 2, 2016
Last verified: February 2016
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.

Condition Intervention Phase
Sleep Initiation and Maintenance Disorders
Drug: Eplivanserin
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 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change from baseline of the mean pr-WASO (wake time after sleep onset using patient's sleep questionnaire) [ Time Frame: at week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Change from baseline of the mean of the FOSQ items 4 and 10 (hobby/work) [ Time Frame: at week 12 ] [ Designated as safety issue: No ]

Enrollment: 967
Study Start Date: November 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eplivanserin
Eplivanserin 5 mg/day
Drug: Eplivanserin
oral administration
Other Name: (SR46349)
Placebo Comparator: Placebo
Placebo of Eplivanserin 5 mg /day
Drug: placebo
oral administration

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


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

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00253968

United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
Sanofi-Aventis Administrative Office
Macquarie Park, Australia
Sanofi-Aventis Administrative Office
Laval, Canada
Sanofi-Aventis Administrative Office
Santiago, Chile
Czech Republic
Sanofi-Aventis Administrative Office
Praha, Czech Republic
Sanofi-Aventis Administrative Office
Paris, France
Sanofi-Aventis Administrative Office
Berlin, Germany
Sanofi-Aventis Administrative Office
Mexico, Mexico
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Sanofi-Aventis Administrative Office
Barcelona, Spain
United Kingdom
Sanofi-Aventis Administrative Office
Guildford, United Kingdom
Sponsors and Collaborators
Study Director: ICD Sanofi
  More Information

Responsible Party: Sanofi Identifier: NCT00253968     History of Changes
Other Study ID Numbers: LTE6217  2005-003080-23 
Study First Received: November 14, 2005
Last Updated: February 2, 2016
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Sanofi:
Primary Insomnia
Early Awakening
Chronic 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 processed this record on October 21, 2016