CLINICAL TRIALS PROFILE FOR PITOLISANT HYDROCHLORIDE
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All Clinical Trials for PITOLISANT HYDROCHLORIDE
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00642928 ↗ | Dose Range Finding Study of BF2.649 Versus Placebo to Treat Excessive Daytime Sleepiness in Parkinson's Disease Patients | Completed | Bioprojet | Phase 2 | 2007-10-01 | The objective of this trial is to define the minimum effective dose of BF 2.649 between 5 mg, 10 mg, 20 mg or 40 mg versus placebo in reducing the Excessive Daytime Sleepiness of Parkinson's disease patients |
| NCT01036139 ↗ | Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease | Completed | Bioprojet | Phase 3 | 2009-12-01 | To compare the efficacy of BF2.649 over placebo (12 week Double-Blind Phase) and assess the long term safety and the efficacy maintenance(9 months Open-Label Extension Phase) of BF2.649 in the improvement of excessive daytime sleepiness in patients diagnosed with Parkinson's Disease. |
| NCT01066442 ↗ | Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease | Completed | Bioprojet | Phase 3 | 2010-03-01 | To compare the efficacy of BF2.649 over placebo (12 week Double-Blind Phase) and assess the long term safety and the efficacy maintenance(9 months Open-Label Extension Phase) of BF2.649 in the improvement of excessive daytime sleepiness in patients diagnosed with Parkinson's Disease. |
| NCT01067222 ↗ | Efficacy and Safety Study of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy | Completed | Bioprojet | Phase 3 | 2009-05-01 | The objective of this study is to evaluate the efficacy and safety of BF2.649 administered by individual titration in narcoleptic patients with excessive daytime sleepiness (EDS) |
| NCT01067235 ↗ | Efficacy and Safety Study of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolespy | Completed | Bioprojet | Phase 3 | 2009-10-01 | The objective of this study is to evaluate and compare the efficacy and safety of escalating doses of BF2.649 and BF2.649 add on Modafinil on cataplexy in patients with narcolepsy |
| NCT01071876 ↗ | BF2.649 in Patients With OSA and Treated by CPAP But Still Complaining of EDS | Completed | Bioprojet | Phase 3 | 2011-08-01 | Multicenter randomized double blind study versus placebo during 12 weeks with at first, an escalating dose period followed by stable dose period at the selected dose. This double-blind period can be followed by a 9 months open-label period if the patient wishes to continue with the study product. |
| NCT01072968 ↗ | BF2.649 in Patients With OSA, Still Complaining of EDS and Refusing to be Treated by CPAP. | Completed | Bioprojet | Phase 3 | 2011-10-01 | Multicenter randomized double blind study versus placebo during 12 weeks with at first, an escalating dose period followed by stable dose period at the selected dose. This double-blind period can be followed by a 9 months open-label period if the patient wishes to continue with the study product. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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