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Last Updated: December 10, 2024

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
>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 12
Narcolepsy 4
Obstructive Sleep Apnea 4
Cataplexy 3
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Condition MeSH

Condition MeSH for Pitolisant Hydrochloride
Intervention Trials
Disorders of Excessive Somnolence 17
Sleepiness 15
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 44
France 11
Switzerland 2
Italy 1
Bulgaria 1
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Trials by US State

Trials by US State for Pitolisant Hydrochloride
Location Trials
Texas 3
Maryland 3
Colorado 3
California 3
North Carolina 3
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Clinical Trial Progress for Pitolisant Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Pitolisant Hydrochloride
Clinical Trial Phase Trials
Phase 4 1
Phase 3 15
Phase 2 6
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Clinical Trial Status

Clinical Trial Status for Pitolisant Hydrochloride
Clinical Trial Phase Trials
Completed 16
Recruiting 5
Not yet recruiting 3
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Clinical Trial Sponsors for Pitolisant Hydrochloride

Sponsor Name

Sponsor Name for Pitolisant Hydrochloride
Sponsor Trials
Bioprojet 19
Harmony Biosciences, LLC 5
National Institute on Alcohol Abuse and Alcoholism (NIAAA) 1
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Sponsor Type

Sponsor Type for Pitolisant Hydrochloride
Sponsor Trials
Other 22
Industry 9
NIH 1
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