Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Efficacy an Safety of Volinanserin on Sleep Maintenance Insomnia With a Sub-study on Stable Type II Diabetes Mellitus (SAMS)

This study has been terminated.
(Sponsor's decision due to absence of demonstration of efficacy of volinanserin in primary insomnia with predominant sleep maintenance problems)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00464061
First received: April 19, 2007
Last updated: August 27, 2009
Last verified: August 2009

April 19, 2007
August 27, 2009
April 2007
March 2009   (final data collection date for primary outcome measure)
  • Efficacy: change from baseline for Sleep Maintenance Insomnia using patient reported Wake After Sleep Onset (pr-WASO) [ Time Frame: at 3 months ] [ Designated as safety issue: No ]
  • Efficacy (sub-study): change from baseline for glycemic measure HbA1c [ Time Frame: at 6 and 12 months ] [ Designated as safety issue: No ]
  • Efficacy: change from baseline to 3 months for Sleep Maintenance Insomnia using patient reported Wake After Sleep Onset (pr-WASO)
  • Efficacy (sub-study): change from baseline to 6 and 12 months for glycemic measure HbA1c
Complete list of historical versions of study NCT00464061 on ClinicalTrials.gov Archive Site
  • Efficacy: change from baseline of the pr-WASO [ Time Frame: at 6 and 12 months ] [ Designated as safety issue: No ]
  • Efficacy: change from baseline of "General Productivity" domain score of the Functional Outcomes of Sleep Questionnaire [ Time Frame: at 3 months ] [ Designated as safety issue: No ]
  • Safety: adverse events and laboratory abnormalities [ Time Frame: during 12 months of treatment ] [ Designated as safety issue: Yes ]
  • Efficacy: change from baseline to 6 and 12 months of the pr-WASO, change from baseline to 3 months of "General Productivity" domain score of the Functional Outcomes of Sleep Questionnaire
  • Safety: adverse events and laboratory abnormalities during 12 months of treatment
Not Provided
Not Provided
 
Efficacy an Safety of Volinanserin on Sleep Maintenance Insomnia With a Sub-study on Stable 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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Sleep Initiation and Maintenance Disorders
  • Drug: volinanserin (M100907)
    oral administration
  • Drug: placebo
    oral administration
  • Experimental: 1
    Intervention: Drug: volinanserin (M100907)
  • Placebo Comparator: 2
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1847
March 2009
March 2009   (final data collection date for primary outcome measure)

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

Sub-study :

  • Patients 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 patient's potential participation in a clinical trial.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Chile,   Colombia,   Czech Republic,   Germany,   Hong Kong,   India,   Italy,   Malaysia,   Mexico,   Russian Federation,   Singapore,   South Africa,   Spain,   Turkey,   United Kingdom
 
NCT00464061
LTE6673, EudraCT : 2006-004942-18
Not Provided
ICD Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: ICD CSD Sanofi
Sanofi
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP