Efficacy an Safety of Volinanserin on Sleep Maintenance Insomnia With a Sub-study on Stable Type II Diabetes Mellitus
Phase 3
Terminated
- Conditions
- Sleep Initiation and Maintenance Disorders
- Interventions
- Drug: Placebo
- Registration Number
- NCT00464061
- Lead Sponsor
- Sanofi
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1847
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Volinanserin Volinanserin - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Efficacy: change from baseline for Sleep Maintenance Insomnia using patient reported Wake After Sleep Onset (pr-WASO) at 3 months Efficacy (sub-study): change from baseline for glycemic measure HbA1c at 6 and 12 months
- Secondary Outcome Measures
Name Time Method Safety: adverse events and laboratory abnormalities during 12 months of treatment Efficacy: change from baseline of the pr-WASO at 6 and 12 months Efficacy: change from baseline of "General Productivity" domain score of the Functional Outcomes of Sleep Questionnaire at 3 months
Trial Locations
- Locations (2)
Sanofi-Aventis Administrative Office
🇬🇧Guildford, Surrey, United Kingdom
Anofi-Aventis Administrative Office
🇭🇰Causeway Bay, Hong Kong