Harmony Biosciences Management, Inc. — Biomedical Watch V2

Traitements2programmes

Essais1liés

Publications2liées

SourceDBlocale

Traitements

2

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
Pitolisant Oral TabletThe primary objective of this study is to evaluate the safety and efficacy of pitolisant compared with placebo in treating excessive daytime sleepiness (EDS) in patients with Myotonic Dystrophy Type 1 ages 18 to 65 years. The secondary objectives of this study are to assess the impact of pitolisant on fatigue, cognitive function and the burden of disease along with assessing the long-term safety and effectiveness of pitolisant in patients with Myotonic Dystrophy Type 1 ages 18 to 65 years.	Myopathies	Phase 2	Traitement symptomatique	United States, Canada	À vérifier
Pitolisant Oral TabletThe primary objective of this study is to evaluate the safety and efficacy of pitolisant compared with placebo in treating excessive daytime sleepiness (EDS) in patients with Myotonic Dystrophy Type 1 ages 18 to 65 years. The secondary objectives of this study are to assess the impact of pitolisant on fatigue, cognitive function and the burden of disease along with assessing the long-term safety and effectiveness of pitolisant in patients with Myotonic Dystrophy Type 1 ages 18 to 65 years.	Myopathies	Phase 2	Traitement symptomatique	United States, Canada	À vérifier

Essais cliniques

1

Molécule	Indication / population	Phase	NCT	Titre	Statut
Pitolisant Oral Tablet	Myopathies	Phase 2	NCT04886518	Safety and Efficacy of Pitolisant on Excessive Daytime Sleepiness and Other Non-Muscular Symptoms in Patients With Myotonic Dystrophy Type 1	COMPLETED

Publications

2

Molécule	Indication / population	Titre	Journal	Date
Pitolisant Oral Tablet		New pharmacologic agents for insomnia and hypersomnia.	Current opinion in pulmonary medicine
Pitolisant Oral Tablet		Evaluating pitolisant as a narcolepsy treatment option.	Expert opinion on pharmacotherapy