NCT00495885|CompletedPhase 3DMC

Efficacy and Safety of M100907 on Sleep Maintenance Insomnia With a Sub-study in Stable Type II Diabetes Mellitus

SAMS12

Efficacy and Safety of 2 mg/Day of M100907 on Sleep Maintenance Insomnia With a Sub-study of the Effect of M100907 on Stable Type II Diabetes Mellitus: a 12-week, Multi-center, Randomized, Double-blind, Placebo-controlled Study

Sanofi ClinicalTrials.gov

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2 other identifiers

LTE6672Eudract: 2006-006677-25

Study Type

interventional

Target

848

Locations

16 countries

Sites

Timeline

RegisteredJul 2007

StartedJun 2007

CompletionOct 2008

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 Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

848

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Jun 2007

Shorter than P25 for phase_3

Geographic Reach

16 countries

16 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

Study Start

First participant enrolled

June 1, 2007

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

July 2, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

July 3, 2007

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed

Last Updated

May 26, 2016

Status Verified

April 1, 2016

Enrollment Period

1.3 years

First QC Date

July 2, 2007

Last Update Submit

April 26, 2016

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

Sleep problemsinsomniasleeplessnessprimary insomniainsomnia disorder

Outcome Measures

Primary Outcomes (1)

change from baseline to 12 weeks for Sleep Maintenance Insomnia using patient reported Wake After Sleep Onset (pr-WASO)
12 weeks

Secondary Outcomes (1)

Change from baseline to 12-week of "General Productivity" domain from Functional Outcomes of Sleep Questionnaire (FOSQ).
12 weeks

Study Arms (2)

Volinanserin

EXPERIMENTAL

Volinanserin 2 mg for a maximum of 87 days

Drug: volinanserin (M100907)

Placebo

PLACEBO COMPARATOR

Placebo for volinanserin for a maximum of 106 days

Drug: Placebo

Interventions

volinanserin (M100907)DRUG

oral, one tablet taken around bedtime

Volinanserin

PlaceboDRUG

oral, one tablet taken around bedtime

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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)

You may not qualify if:

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.

Contact the study team to confirm eligibility.