CLINICAL TRIALS PROFILE FOR EPLIVANSERIN
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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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
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