CLINICAL TRIALS PROFILE FOR EPLIVANSERIN

Clinical Trials for Eplivanserin

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00253903 ↗	Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia Followed by Optional Extension up to 1 Year	Completed	Sanofi	Phase 3	The purpose of the study is to assess efficacy and safety of eplivanserin 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 nonrestorative and they suffer from a significant distress or impairment in their daily activities consecutive to insomnia.
NCT00253968 ↗	Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia	Completed	Sanofi	Phase 3	The purpose of the study is to assess efficacy and safety of eplivanserin 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 nonrestorative and they suffer from a significant distress or impairment in their daily activities consecutive to insomnia.
NCT00308503 ↗	Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia	Completed	Sanofi	Phase 3	The aim of the study is to confirm the efficacy of eplivanserin 5mg/day on sleep maintenance of patients with primary insomnia using night polysomnography recordings over a 6-week treatment period corresponding to a stabilization of improvement of sleep.
NCT00313885 ↗	Efficacy and Safety of SR46349B in Patients With Sleep Disorders in Fibromyalgia	Completed	Sanofi	Phase 2	Fibromyalgics frequently report sleep disturbances, in particular poor and unrefreshing sleep. Additionally, studies have reported that sleep problems, pain and mood disturbances are associated in patients with fibromyalgia. By improving the quality of sleep, complaints of poor and unrefreshing sleep, fatigue, pain, which are among the main components of this chronic pain disorder may be improved.
NCT00679900 ↗	Comparison of Eplivanserin and Lormetazepam in the Treatment of Insomnia Characterized by Sleep Maintenance Difficulties	Completed	Sanofi	Phase 3	The primary objective is to compare the potential for next-day residual effects of eplivanserin 5 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. The 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 Eplivanserin

Condition Name

Condition Name
Intervention	Trials
Sleep Initiation and Maintenance Disorders	5
Insomnia	3
Primary Insomnia	1
Sleep	1

Condition MeSH

Condition MeSH
Intervention	Trials
Sleep Initiation and Maintenance Disorders	6
Sleep Wake Disorders	1
Parasomnias	1
Myofascial Pain Syndromes	1

Clinical Trial Locations for Eplivanserin

Trials by Country

Trials by Country
Location	Trials
United States	14
Canada	5
France	4
Netherlands	3
Germany	3

Trials by US State

Trials by US State
Location	Trials
New Jersey	4
Washington	1
Utah	1
Nebraska	1
Kansas	1

Clinical Trial Progress for Eplivanserin

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 3	5
Phase 2	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Completed	7

Clinical Trial Sponsors for Eplivanserin

Sponsor Name

Sponsor Name
Sponsor	Trials
Sanofi	7

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	7