Efficacy and Safety of Volinanserin on Sleep Maintenance Insomnia - Polysomnographic Study (NOCTURNE907)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00464243
First received: April 20, 2007
Last updated: February 16, 2009
Last verified: February 2009
  Purpose

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.


Condition Intervention Phase
Sleep Initiation and Maintenance Disorders
Drug: volinanserin (M100907)
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change from baseline to 6 weeks of treatment of the mean night polysomnographic (NPSG) wake time after sleep onset (WASO). [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional Outcomes of Sleep Questionnaire at 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 604
Study Start Date: April 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: volinanserin (M100907)
oral administration
Placebo Comparator: 2 Drug: placebo
oral administration

  Eligibility

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

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.

  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: NCT00464243

Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Australia, New South Wales
Sanofi-Aventis Administrative Office
Cove, New South Wales, Australia
Austria
Sanofi-Aventis Administrative Office
Vienna, Austria
Canada, Quebec
Sanofi-Aventis Administrative Office
Laval, Quebec, Canada
France
Sanofi-Aventis Administrative Office
Paris, France
Germany
Sanofi-Aventis Administrative Office
Berlin, Germany
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

Additional Information:
No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00464243     History of Changes
Other Study ID Numbers: EFC6072, EUDRACT : 2006-005303-34
Study First Received: April 20, 2007
Last Updated: February 16, 2009
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Sanofi:
Sleep problems
Insomnia
Sleeplessness
Polysomnographic

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
MDL 100907
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 20, 2014