Clinical trials

4

Search and review clinical trials. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH)

This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled clinical study to assess the efficacy and safety of HBS-301 in adult participants (ages ≥18 years) with idiopathic hypersomnia (IH).

Participants needed: 248
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Harmony Biosciences Management, Inc.Updated: Jul 2, 2026Locations: 22
Eligibility criteria

Has a current documented diagnosis of IH per the International Classification of... [+3]

Has hypersomnia due to another medical disorder. [+5]

Status: Recruiting

A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy

This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled clinical study to assess the efficacy and safety of HBS-301 in treating excessive daytime sleepiness (EDS), cataplexy, sleepiness/wakefulness, and fatigue in adult participants (ages ≥18 years) with narcolepsy.

Participants needed: 258
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Harmony Biosciences Management, Inc.Updated: Jun 30, 2026Locations: 14
Eligibility criteria

Has a current documented diagnosis of NT1 or NT2 per the International Classific... [+2]

Has hypersomnia due to another medical disorder. [+6]

Status: Recruiting

WAKIX® (Pitolisant) Pregnancy Registry

The WAKIX (pitolisant) Pregnancy Registry is a US-based, prospective, observational cohort study designed to evaluate the association between pitolisant exposure during pregnancy and subsequent maternal, fetal, and infant outcomes.

Participants needed: 1,329
Trial details
Biological sex: FemaleType: ObservationalSponsor: Harmony Biosciences Management, Inc.Updated: Jun 12, 2026Locations: 1Duration: 21 Months
Eligibility criteria

Pregnant woman of any age [+4]

Status: Recruiting

A Study of Pitolisant in Patients With Prader-Willi Syndrome

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, global clinical study to assess the efficacy and safety of pitolisant in patients living with Prader-Willi syndrome. The primary objective of this study is to evaluate the efficacy of pitolisant in treating excessive daytime sleepiness (EDS) in patients ≥6 years of age with Prader-Willi syndrome. Secondary objectives include assessing the impact of pitolisant on: Irritable and disruptive behaviors Hyperphagia Other behavioral problems including social withdrawal, stereotypic behavior, hyperactivity/noncompliance, and inappropriate speech

Participants needed: 134
Trial details
Phase: Phase 3Age: 6+Biological sex: AllType: InterventionalSponsor: Harmony Biosciences Management, Inc.Updated: Mar 17, 2026Locations: 54
Eligibility criteria

Genetically confirmed diagnosis of PWS [+3]

Has a diagnosis of sleep apnea (OSA, CSA) that is not adequately controlled [+2]