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Last Updated: July 3, 2022

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 >Phase >Start Date >Summary

Clinical Trial Conditions for Pitolisant Hydrochloride

Condition Name

Condition Name for Pitolisant Hydrochloride
Intervention Trials
Excessive Daytime Sleepiness 11
Narcolepsy 4
Obstructive Sleep Apnea 4
Parkinson's Disease 3
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Condition MeSH

Condition MeSH for Pitolisant Hydrochloride
Intervention Trials
Disorders of Excessive Somnolence 16
Sleepiness 14
Narcolepsy 7
Cataplexy 5
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Clinical Trial Locations for Pitolisant Hydrochloride

Trials by Country

Trials by Country for Pitolisant Hydrochloride
Location Trials
United States 20
France 11
Switzerland 2
North Macedonia 1
Italy 1
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Trials by US State

Trials by US State for Pitolisant Hydrochloride
Location Trials
Maryland 2
Colorado 2
California 2
North Carolina 2
Pennsylvania 1
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Clinical Trial Progress for Pitolisant Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Pitolisant Hydrochloride
Clinical Trial Phase Trials
Phase 3 14
Phase 2 6
Phase 1 5
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Clinical Trial Status

Clinical Trial Status for Pitolisant Hydrochloride
Clinical Trial Phase Trials
Completed 16
Recruiting 3
Withdrawn 2
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Clinical Trial Sponsors for Pitolisant Hydrochloride

Sponsor Name

Sponsor Name for Pitolisant Hydrochloride
Sponsor Trials
Bioprojet 19
Harmony Biosciences, LLC 3
Clayton A. Dehn 1
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Sponsor Type

Sponsor Type for Pitolisant Hydrochloride
Sponsor Trials
Other 20
Industry 7
NIH 1
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