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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00464243




Registration number
NCT00464243
Ethics application status
Date submitted
20/04/2007
Date registered
23/04/2007
Date last updated
8/08/2017

Titles & IDs
Public title
Efficacy and Safety of Volinanserin on Sleep Maintenance Insomnia - Polysomnographic Study
Scientific title
Efficacy and Safety of 2 mg/Day M100907 on Sleep Maintenance Insomnia: a 6-week, Multicenter, Randomized, Double-blind, Placebo-controlled Polysomnographic Study
Secondary ID [1] 0 0
EUDRACT : 2006-005303-34
Secondary ID [2] 0 0
EFC6072
Universal Trial Number (UTN)
Trial acronym
NOCTURNE907
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Initiation and Maintenance Disorders 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - volinanserin
Treatment: Drugs - placebo

Experimental: Volinanserin - 2 mg volinanserin tablets orally once daily

Placebo comparator: Placebo - tablets orally once daily


Treatment: Drugs: volinanserin
oral administration

Treatment: Drugs: placebo
oral administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline to 6 weeks of treatment of the mean night polysomnographic (NPSG) wake time after sleep onset (WASO).
Timepoint [1] 0 0
6 weeks
Secondary outcome [1] 0 0
Functional Outcomes of Sleep Questionnaire at 6 weeks
Timepoint [1] 0 0
6 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2008
Sample size
Target
Accrual to date
Final
604
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Sanofi-Aventis Administrative Office - Cove
Recruitment postcode(s) [1] 0 0
- Cove
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Jersey
Country [2] 0 0
Austria
State/province [2] 0 0
Vienna
Country [3] 0 0
Canada
State/province [3] 0 0
Quebec
Country [4] 0 0
France
State/province [4] 0 0
Paris
Country [5] 0 0
Germany
State/province [5] 0 0
Berlin
Country [6] 0 0
Russian Federation
State/province [6] 0 0
Moscow

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
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 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.
Trial website
https://clinicaltrials.gov/study/NCT00464243
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ICD CSD
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00464243