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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00253968
First received: November 14, 2005
Last updated: November 29, 2010
Last verified: November 2010
  Purpose

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

Detailed Description:

The study is being conducted world-wide. It consists of 3 segments:

  • Segment A: 7-day run-in (screening).
  • Segment B: 12-week double blind treatment.
  • Segment C: 2-week Run-out period

An IVR system will be used to register patients, report completion of certain phases of the trial, and to discontinue patients. In addition, a daily patient diary will be completed via the IVRS. A central laboratory for processing blood specimens will be used. Patients will be requested to complete questionnaires at each visit, including completion of the FOSQ (Functional Outcome of Sleep Questionnaire) the evening prior to each visit.

  Eligibility

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

Inclusion Criteria:

  • Out patients
  • Each patient must have primary insomnia in accordance with DSM-IV-TR-Axis I 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 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 ClinicalTrials.gov identifier: NCT00253968

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

No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00253968     History of Changes
Other Study ID Numbers: LTE6217, EudraCT: 2005-003080-23
Study First Received: November 14, 2005
Last Updated: November 29, 2010
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
Sleeplessness
Early Awakening
Chronic Insomnia

Additional relevant MeSH terms:
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 September 16, 2014