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

Sleep Initiation and Maintenance Disorders Clinical Trial

— NOCTURNE907  

Official title:

Efficacy and Safety of 2 mg/Day M100907 on Sleep Maintenance Insomnia: a 6-week, Multicenter, Randomized, Double-blind, Placebo-controlled Polysomnographic Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00464243
• Other study ID #: EFC6072
• Secondary ID: EUDRACT : 2006-0
• Status: Completed
• Phase: Phase 3
• First received: April 20, 2007
• Last updated: August 4, 2017
• Start date: April 2007
• Est. completion date: January 2008

Study information

• Verified date: August 2017
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 604
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• volinanserin
oral administration
• placebo
oral administration

Locations

Country	Name	City	State
Australia	Sanofi-Aventis Administrative Office	Cove	New South Wales
Austria	Sanofi-Aventis Administrative Office	Vienna
Canada	Sanofi-Aventis Administrative Office	Laval	Quebec
France	Sanofi-Aventis Administrative Office	Paris
Germany	Sanofi-Aventis Administrative Office	Berlin
Russian Federation	Sanofi-Aventis Administrative Office	Moscow
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  France,  Germany,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to 6 weeks of treatment of the mean night polysomnographic (NPSG) wake time after sleep onset (WASO).		6 weeks
Secondary	Functional Outcomes of Sleep Questionnaire at 6 weeks		6 weeks

External Links

•   Link