Status:
COMPLETED
Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia
Lead Sponsor:
Sanofi
Conditions:
Sleep Initiation and Maintenance Disorders
Insomnia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
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
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
967 Patients enrolled
Trial Details
Trial ID
NCT00253968
Start Date
November 1 2005
End Date
January 1 2008
Last Update
March 1 2016
Active Locations (12)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
3
Sanofi-Aventis Administrative Office
Macquarie Park, Australia
4
Sanofi-Aventis Administrative Office
Laval, Canada