CLINICAL TRIALS PROFILE FOR VOLINANSERIN

Clinical Trials for Volinanserin

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00464061 ↗	Efficacy an Safety of Volinanserin on Sleep Maintenance Insomnia With a Sub-study on Stable Type II Diabetes Mellitus	Terminated	Sanofi	Phase 3	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.
NCT00464243 ↗	Efficacy and Safety of Volinanserin on Sleep Maintenance Insomnia - Polysomnographic Study	Completed	Sanofi	Phase 3	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.
NCT00495885 ↗	Efficacy and Safety of M100907 on Sleep Maintenance Insomnia With a Sub-study in Stable Type II Diabetes Mellitus	Completed	Sanofi	Phase 3	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.
NCT00788515 ↗	Comparison of Volinanserin and Lormetazepam in the Treatment of Insomnia Characterized by Sleep Maintenance Difficulties	Terminated	Sanofi	Phase 3	The primary objective is to compare the potential for next-day residual effects of volinanserin 2 mg/day and lormetazepam 1 mg/day by measuring the sleepiness in the morning using the patient's sleep questionnaire during 4 weeks of treatment in patients with chronic primary insomnia and sleep maintenance difficulties. Secondary objectives are to compare the clinical safety of both products, including the potential for rebound insomnia and withdrawal symptoms after treatment discontinuation, to compare the efficacy of both products on subjective sleep parameters and to compare the effects of both products on patient's daytime functioning.

Clinical Trial Conditions for Volinanserin

Condition Name

Condition Name for
Intervention	Trials
Sleep Initiation and Maintenance Disorders	4

Condition MeSH

Condition MeSH for
Intervention	Trials
Sleep Initiation and Maintenance Disorders	4
Diabetes Mellitus	2
Diabetes Mellitus, Type 2	2

Clinical Trial Locations for Volinanserin

Trials by Country

Trials by Country for
Location	Trials
France	3
Canada	3
United States	3
Russian Federation	3
Australia	2

Trials by US State

Trials by US State for
Location	Trials
New Jersey	3

Clinical Trial Progress for Volinanserin

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 3	4

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Completed	2
Terminated	2

Clinical Trial Sponsors for Volinanserin

Sponsor Name

Sponsor Name for
Sponsor	Trials
Sanofi	4

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	4