Efficacy and Safety of Volinanserin on Sleep Maintenance Insomnia - Polysomnographic Study

Completed · Phase 3 · Has a placebo group

Conditions studied: Sleep Initiation and Maintenance Disorders

In brief

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 frequently wake up during the night, their sleep is non restorative and they suffer from a significant distress or impairment in their daily activities consecutive to insomnia.

Key facts

Study ID

NCT00464243

Run by

Sanofi

People needed

604

Starts

2007-04-01

Expected to finish

2008-01-01

Last updated by the study team

2017-08-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States
• Sanofi-Aventis Administrative Office — Cove, New South Wales, Australia
• Sanofi-Aventis Administrative Office — Vienna, Austria
• Sanofi-Aventis Administrative Office — Laval, Quebec, Canada
• Sanofi-Aventis Administrative Office — Paris, France
• Sanofi-Aventis Administrative Office — Berlin, Germany
• Sanofi-Aventis Administrative Office — Moscow, Russia

Full record on ClinicalTrials.gov

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