Sleep Initiation and Maintenance Disorders
Conditions
Keywords
Sleep problems, Insomnia, Sleeplessness, Primary insomnia, Insomnia disorder
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.
Interventions
DRUGVolinanserin
oral administration
DRUGPlacebo
oral administration
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Safety: adverse events and laboratory abnormalities | during 12 months of treatment |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czechia, Germany, Hong Kong, India, Italy, Malaysia, Mexico, Russia, Singapore, South Africa, Spain, Turkey (Türkiye), United Kingdom, United States
Outcome results
None listed