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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00464061




Registration number
NCT00464061
Ethics application status
Date submitted
19/04/2007
Date registered
20/04/2007
Date last updated
26/05/2016

Titles & IDs
Public title
Efficacy an Safety of Volinanserin on Sleep Maintenance Insomnia With a Sub-study on Stable Type II Diabetes Mellitus
Scientific 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
Secondary ID [1] 0 0
EudraCT : 2006-004942-18
Secondary ID [2] 0 0
LTE6673
Universal Trial Number (UTN)
Trial acronym
SAMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Initiation and Maintenance Disorders 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Volinanserin
Treatment: Drugs - Placebo

Experimental: Volinanserin -

Placebo Comparator: Placebo -


Treatment: Drugs: Volinanserin
oral administration

Treatment: Drugs: Placebo
oral administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Efficacy: change from baseline for Sleep Maintenance Insomnia using patient reported Wake After Sleep Onset (pr-WASO)
Timepoint [1] 0 0
at 3 months
Primary outcome [2] 0 0
Efficacy (sub-study): change from baseline for glycemic measure HbA1c
Timepoint [2] 0 0
at 6 and 12 months
Secondary outcome [1] 0 0
Efficacy: change from baseline of the pr-WASO
Timepoint [1] 0 0
at 6 and 12 months
Secondary outcome [2] 0 0
Efficacy: change from baseline of "General Productivity" domain score of the Functional Outcomes of Sleep Questionnaire
Timepoint [2] 0 0
at 3 months
Secondary outcome [3] 0 0
Safety: adverse events and laboratory abnormalities
Timepoint [3] 0 0
during 12 months of treatment

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2009
Sample size
Target
Accrual to date
Final
1847
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-Aventis Administrative Office - Macquarie Park
Recruitment postcode(s) [1] 0 0
- Macquarie Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Jersey
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Austria
State/province [3] 0 0
Vienna
Country [4] 0 0
Belgium
State/province [4] 0 0
Diegem
Country [5] 0 0
Brazil
State/province [5] 0 0
Sao Paulo
Country [6] 0 0
Canada
State/province [6] 0 0
Laval
Country [7] 0 0
Chile
State/province [7] 0 0
Santiago
Country [8] 0 0
Colombia
State/province [8] 0 0
Santafe de Bogota
Country [9] 0 0
Czech Republic
State/province [9] 0 0
Praha
Country [10] 0 0
Germany
State/province [10] 0 0
Berlin
Country [11] 0 0
Hong Kong
State/province [11] 0 0
Causeway Bay
Country [12] 0 0
India
State/province [12] 0 0
Mumbai
Country [13] 0 0
Italy
State/province [13] 0 0
Milano
Country [14] 0 0
Malaysia
State/province [14] 0 0
Kuala Lumpur
Country [15] 0 0
Mexico
State/province [15] 0 0
Mexico
Country [16] 0 0
Russian Federation
State/province [16] 0 0
Moscow
Country [17] 0 0
Singapore
State/province [17] 0 0
Singapore
Country [18] 0 0
South Africa
State/province [18] 0 0
Midrand
Country [19] 0 0
Spain
State/province [19] 0 0
Barcelona
Country [20] 0 0
Turkey
State/province [20] 0 0
Istanbul
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00464061
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ICD CSD
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00464061