Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00495885 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of M100907 on Sleep Maintenance Insomnia With a Sub-study in Stable Type II Diabetes Mellitus
A Phase 3 study of Sleep Initiation and Maintenance Disorders, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 848
- Enrollment target
- 16
- Study locations
NCT00495885: Completed Phase 3 study of Sleep Initiation and Maintenance Disorders, sponsored by Sanofi.
NCT00495885 is a Phase 3 study of Sleep Initiation and Maintenance Disorders that has completed, run by Sanofi. The registered enrollment target is 848 participants, above the 245-participant average among 19 other Sleep Initiation and Maintenance Disorders trials with a reported enrollment target (246% higher). The trial reports 16 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00495885, a Phase 3 study of Sleep Initiation and Maintenance Disorders, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 848 participants
- Enrollment target
- 16
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG volinanserin (M100907)
Study Locations (16)
Other
- Sanofi-Aventis Administrative Office - São Paulo
- Sanofi-Aventis Administrative Office - Laval
- Sanofi-Aventis Administrative Office - Bogotá
- Sanofi-Aventis Administrative Office - Prague
- Sanofi-Aventis Administrative Office - Helsinki
- Sanofi-Aventis Administrative Office - Paris
- Sanofi-Aventis Administrative Office - Athens
- Sanofi-Aventis Administrative Office - Milan
- Sanofi-Aventis Administrative Office - Kuala Lumpur
- Sanofi-Aventis Administrative Office - Gouda
- Sanofi-Aventis Administrative Office - Moscow
- Sanofi-Aventis Administrative Office - Midrand
- Sanofi-Aventis Administrative Office - Geneva
- Sanofi-Aventis Administrative Office - Taipei
- Sanofi-Aventis Administrative Office - Istanbul
New Jersey
- Sanofi-Aventis Administrative Office - Bridgewater
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 848 participants |
| Start Date | 2007-06 |
| Est. Completion | 2008-10 |
| Phase | Phase 3 |
What the finished NCT00495885 record still lists
NCT00495885 is an interventional study that assigns participants to a tested intervention. The registered 848 participants enrollment target is mid-sized for trials with a published cap, above the 245-participant average among 19 other Sleep Initiation and Maintenance Disorders trials with a reported enrollment target (246% higher).
The record links to 1 condition, with Sleep Initiation and Maintenance Disorders appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00495885 lists 16 locations in 2 states (Other, New Jersey).
Frequently Asked Questions
What is clinical trial NCT00495885 about?
NCT00495885 is a clinical study titled "Efficacy and Safety of M100907 on Sleep Maintenance Insomnia With a Sub-study in Stable Type II Diabetes Mellitus". 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.
What is the current status of trial NCT00495885?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 848 participants. The study started on 2007-06. Estimated completion is 2008-10.
What conditions does trial NCT00495885 study?
This clinical trial studies the following conditions: Sleep Initiation and Maintenance Disorders.
What interventions are being tested in trial NCT00495885?
The interventions under investigation include: Placebo (DRUG), volinanserin (M100907) (DRUG).
Who is sponsoring clinical trial NCT00495885?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00495885 being conducted?
This trial has 16 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Sleep Initiation and Maintenance Disorders
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00495885's enrollment target sits among peer trials
848 3rd of 19 higher than 17 of 19 other Sleep Initiation and Maintenance Disorders trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sleep Initiation and Maintenance Disorders trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Efficacy of Ramelteon in Subjects With Chronic Insomnia
COMPLETED · Phase 3
-
Mindfulness Meditation for Insomnia
RECRUITING · Phase 1
-
Optimizing Sleep Health in Nurses
RECRUITING · NA
-
Sleep Healthy Using the Internet Mitigating Insomnia to Address Neurocognitive Difficulties (SHUTi MIND)
RECRUITING · Phase 2
-
Sleep for Health Study on the Effects of Cognitive Behavioral Therapy for Insomnia on Diabetes Risk
RECRUITING · NA
-
Suvorexant: A Dual Orexin Receptor Antagonist for Treating Sleep Disturbance in Posttraumatic Stress
RECRUITING · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT07142408 · 848 participants · Phase 3
The Effect of Bacterial Decolonization Before Skin Cancer Surgery on Infection Rate of Lower Extremity Wounds Left Open to Heal
- NCT03507257 · 850 participants
Longitudinal Early-onset Alzheimer's Disease Study Protocol
- NCT05846841 · 850 participants · NA
Personalized Tobacco Treatment in Primary Care (MOTIVATE)
- NCT05987059 · 850 participants · Phase 2
Involving Communities in Addressing the Maternal Health Crisis: Making an IMPACT
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia