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 patients suffering from that condition frequently wake up during the night, their sleep is non restorative and they suffer from a significant distress or impairment in their daily activities consecutive to insomnia.

Trial Health

On Track

Trial Health Score

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

Enrollment

604

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Apr 2007

Shorter than P25 for phase_3

Geographic Reach

6 countries

6 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

9 months study duration

Study Start

First participant enrolled

April 1, 2007

Completed

19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2007

Completed

3 days until next milestone

First Posted

Study publicly available on registry

April 23, 2007

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed

Last Updated

August 8, 2017

Status Verified

August 1, 2017

Enrollment Period

9 months

First QC Date

April 20, 2007

Last Update Submit

August 4, 2017

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

Sleep problemsInsomniaSleeplessnessPolysomnographic

Outcome Measures

Primary Outcomes (1)

Change from baseline to 6 weeks of treatment of the mean night polysomnographic (NPSG) wake time after sleep onset (WASO).
6 weeks

Secondary Outcomes (1)

Functional Outcomes of Sleep Questionnaire at 6 weeks
6 weeks

Study Arms (2)

Volinanserin

EXPERIMENTAL

2 mg volinanserin tablets orally once daily

Drug: volinanserin

Placebo

PLACEBO COMPARATOR

tablets orally once daily

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 patient's information related to sleep pattern during the preceding month
Specific criteria based on the NPSG recordings during the screening nights

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.