Clinical trial NCT00464061: Efficacy an Safety of Volinanserin on Sleep Maintenance Insomnia With a Sub-study on Stable Type II Diabetes Mellitus
Official title: Efficacy and Safety of 2mg/Day of M100907 on Sleep Maintenance Insomnia With a Sub-study of the Effect of M100907 on Stable Type II Diabetes Mellitus: a One Year, Multi-center, Randomized, Double-blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Sleep Initiation and Maintenance Disorders
Keywords: Sleep problems
Insomnia
Sleeplessness
Primary insomnia
Insomnia disorder
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-04-20
Enrollment: 1847
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 objective of the substudy is to assess glycemic control in the subgroup of patients with type II diabetes mellitus.


Eligibility 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 participant's information related to sleep pattern during the preceding month

Sub-study :

* Participants will be included if they have an established medical diagnosis of type II Diabetes Mellitus, and have been treated either with an oral hypoglycemic agent and/or insulin for at least three months prior to the Screening Visit (with stable regimen for at least one month prior to screening)

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 participant's potential participation in a clinical trial.

Primary outcomes:
measure: Efficacy: change from baseline for Sleep Maintenance Insomnia using patient reported Wake After Sleep Onset (pr-WASO)
timeFrame: at 3 months
measure: Efficacy (sub-study): change from baseline for glycemic measure HbA1c
timeFrame: at 6 and 12 months
Secondary outcomes:
measure: Efficacy: change from baseline of the pr-WASO
timeFrame: at 6 and 12 months
measure: Efficacy: change from baseline of "General Productivity" domain score of the Functional Outcomes of Sleep Questionnaire
timeFrame: at 3 months
measure: Safety: adverse events and laboratory abnormalities
timeFrame: during 12 months of treatment
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis Administrative Office
state: New Jersey
city: Buenos Aires
country: Argentina
facility: Sanofi-Aventis Administrative Office
city: Macquarie Park
country: Australia
facility: Sanofi-Aventis Administrative Office
city: Vienna
country: Austria
facility: Sanofi-Aventis Administrative Office
city: Diegem
country: Belgium
facility: Sanofi-Aventis Administrative Office
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
city: Laval
country: Canada
facility: Sanofi-Aventis Administrative Office
city: Santiago
country: Chile
facility: Sanofi-Aventis Administrative Office
city: Santafe de Bogota
country: Colombia
facility: Sanofi-Aventis Administrative Office
city: Praha
country: Czech Republic
facility: Sanofi-Aventis Administrative Office
city: Berlin
country: Germany
facility: Sanofi-Aventis Administrative Office
city: Causeway Bay
country: Hong Kong
facility: Anofi-Aventis Administrative Office
city: Mumbai
country: India
facility: Sanofi-Aventis Administrative Office
city: Milano
country: Italy
facility: Sanofi-Aventis Administrative Office
city: Kuala Lumpur
country: Malaysia
facility: Sanofi-Aventis Administrative Office
city: Mexico
country: Mexico
facility: Sanofi-Aventis Administrative Office
city: Moscow
country: Russian Federation
facility: Sanofi-Aventis Administrative Office
city: Singapore
country: Singapore
facility: Sanofi-Aventis Administrative Office
city: Midrand
country: South Africa
facility: Sanofi-Aventis Administrative Office
city: Barcelona
country: Spain
facility: Sanofi-Aventis Administrative Office
city: Istanbul
country: Turkey
facility: Sanofi-Aventis Administrative Office
city: Guildford
country: United Kingdom
facility: Sanofi-Aventis Administrative Office
state: Surrey
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References: