Status:
COMPLETED
Efficacy and Safety of Volinanserin on Sleep Maintenance Insomnia - Polysomnographic Study
Lead Sponsor:
Sanofi
Conditions:
Sleep Initiation and Maintenance Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess efficacy and safety of volinanserin in the population of patients complaining of sleep maintenance insomnia. The patients suffering from that condition frequentl...
Eligibility Criteria
Inclusion
- Diagnosis of primary insomnia based on Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) criteria
- Disturbances of sleep maintenance criteria based on patient's information related to sleep pattern during the preceding month
- Specific criteria based on the NPSG recordings during the screening nights
Exclusion
- Females who are lactating or who are pregnant
- Night shift workers, and individuals who nap 3 or more times per week over the preceding month
- Consumption of xanthine-containing beverages (i.e. tea, coffee, cola) comprising more than 5 cups/day
- Participation in another trial having received study medication within 1 month before the screening visit
- Body Mass Index ≥ 33
- Use of over-the-counter medications such as tryptophan, valerian root, kava, melatonin, St. John's Wort, Alluna or prescription sleep medication
- Use of any substance with psychotropic effects or properties know to affect sleep/wake
- History of primary hypersomnia, narcolepsy, breathing-related sleep disorder, circadian rhythm sleep disorder, parasomnia, dyssomnia
- Clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder
- Positive qualitative urine drug screen (opiates, cocaine, amphetamine…)
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
604 Patients enrolled
Trial Details
Trial ID
NCT00464243
Start Date
April 1 2007
End Date
January 1 2008
Last Update
August 8 2017
Active Locations (7)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Cove, New South Wales, Australia
3
Sanofi-Aventis Administrative Office
Vienna, Austria
4
Sanofi-Aventis Administrative Office
Laval, Quebec, Canada