7 completed. 5 Phase 3, 1 Phase 1, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 5 | Completed 5 |
| Phase 1 | 1 | Completed 1 |
| Phase 2 | 1 | Completed 1 |
Follow SR 46349B: new trials by email Literature Review of SR 46349B trials Research Report on SR 46349B
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Single Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Evaluation of Eplivanserin in Children With Insomnia Eplivanserin (SR46349) - Sleep Initiation and Maintenance Disorders | Phase 1 | Completed | Sanofi | 41 | 2009-06-01 | 2010-11-30 |
| Efficacy and Safety of Eplivanserin 5mg/Day in Insomnia Characterized by Sleep Maintenance Difficulties Eplivanserin, Placebo - Primary Insomnia | Phase 3 | Completed | Sanofi | 637 | 2008-12-01 | 2016-03-07 |
| Comparison of Eplivanserin and Lormetazepam in the Treatment of Insomnia Characterized by Sleep Maintenance Difficulties eplivanserin (SR46349), lormetazepam - Sleep Initiation and Maintenance Disorders | Phase 3 | Completed | Sanofi | 283 | 2008-04-01 | 2010-11-30 |
| Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia eplivanserin (SR46349), placebo - Sleep Initiation and Maintenance Disorders, Insomnia | Phase 3 | Completed | Sanofi | 608 | 2006-02-01 | 2010-11-30 |
| Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia Eplivanserin, placebo - Sleep Initiation and Maintenance Disorders, Insomnia | Phase 3 | Completed | Sanofi | 967 | 2005-11-01 | 2016-03-01 |
| Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia Followed by Optional Extension up to 1 Year eplivanserin (SR46349), placebo - Sleep Initiation and Maintenance Disorders, Insomnia | Phase 3 | Completed | Sanofi | 1155 | 2005-11-01 | 2010-11-30 |
| Efficacy and Safety of SR46349B in Patients With Sleep Disorders in Fibromyalgia eplivanserin (SR46349), placebo - Fibromyalgia, Sleep | Phase 2 | Completed | Sanofi | 205 | 2004-04-01 | 2010-11-30 |
Sleep Initiation and Maintenance Disorders (6) · Chronic Pain (1) · Fibromyalgia (1)
Sanofi (7)
United States (6) · Canada (5) · France (4) · Australia (3) · Chile (3) · Germany (3) · Netherlands (3) · Spain (3) · Argentina (2) · Austria (2) · Czechia (2) · Finland (2) · Mexico (2) · United Kingdom (2) · Estonia (1)
2005 (1), 2008 (1)