Efficacy an Safety of Volinanserin on Sleep Maintenance Insomnia With a Sub-study on Stable Type II Diabetes Mellitus (SAMS)
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ClinicalTrials.gov Identifier: NCT00464061
(Sponsor's decision due to absence of demonstration of efficacy of volinanserin in primary insomnia with predominant sleep maintenance problems)
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.
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 Start Date
Actual Primary Completion Date
Actual Study Completion Date
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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)
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.