NCT00464061|TerminatedPhase 3

Study Stopped

Sponsor's decision due to absence of demonstration of efficacy of volinanserin in primary insomnia with predominant sleep maintenance problems

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

SAMS

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

Sanofi ClinicalTrials.gov

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2 other identifiers

LTE6673EudraCT : 2006-004942-18

Study Type

interventional

Target

1,847

Locations

21 countries

Sites

Timeline

RegisteredApr 2007

StartedApr 2007

CompletionMar 2009

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

Monitor

Trial Health Score

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

Enrollment

1,847

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Apr 2007

Geographic Reach

21 countries

21 active sites

Status

terminated

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

1.9 years study duration

Study Start

First participant enrolled

April 1, 2007

Completed

18 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

April 20, 2007

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed

Last Updated

May 26, 2016

Status Verified

April 1, 2016

Enrollment Period

1.9 years

First QC Date

April 19, 2007

Last Update Submit

April 26, 2016

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

Sleep problemsInsomniaSleeplessnessPrimary insomniaInsomnia disorder

Outcome Measures

Primary Outcomes (2)

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 Outcomes (3)

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

Study Arms (2)

Volinanserin

EXPERIMENTAL

Drug: Volinanserin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

VolinanserinDRUG

oral administration

Also known as: M100907

Volinanserin

PlaceboDRUG

oral administration

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 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)

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 participant's potential participation in a clinical trial.

Contact the study team to confirm eligibility.