Clinical trials: Primary Hypersomnia
Idiopathic Hypersomnia, Narcolepsy
A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or Narcolepsy
This study will assess the safety and efficacy of JZP258 (XYWAV) on sleepiness, polysomnography, and functional outcomes in patients with idiopathic hypersomnia (IH) or narcolepsy.
- Trial name
- NCT05875974
- Testing
- JZP258 (XYWAV)
- Where
- 32 sites in United States, Canada
- Volunteers
- 199 people
- Sponsor
- Jazz Pharmaceuticals
Idiopathic Hypersomnia
A Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension
This is a study of the efficacy and safety of JZP-258, an oxybate mixed-salts oral solution being developed as a low sodium alternative product for Xyrem.
- Trial name
- NCT03533114
- Testing
- JZP-258
- Where
- 63 sites in United States, Belgium and 6 more
- Volunteers
- 154 people
- Sponsor
- Jazz Pharmaceuticals
Idiopathic Hypersomnia
A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia
The primary objective of this study is to evaluate the safety and efficacy of pitolisant compared with placebo in treating excessive daytime sleepiness (EDS) in participants with idiopathic hypersomnia (IH) age ≥18 years.
- Trial name
- NCT05156047
- Testing
- Open-label Pitolisant, Double-blind Pitolisant
- Where
- 58 sites in United States
- Volunteers
- 214 people
- Sponsor
- Harmony Biosciences Management, Inc.
Idiopathic Hypersomnia
A Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic Hypersomnia
The purpose of this study is to evaluate the safety and tolerability of administering a single intravenous (IV) infusion dose of TAK-925 to adult participants with idiopathic hypersomnia (IH).
- Trial name
- NCT04091438
- Testing
- TAK-925
- Where
- 22 sites in United States, Japan
- Volunteers
- 28 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Idiopathic Hypersomnia
Study of SDX in Patients With Idiopathic Hypersomnia (IH)
This is a study of the safety, efficacy and pharmacokinetics (PK) of Serdexmethylphenidate (SDX) compared to placebo in subjects with Idiopathic Hypersomnia (IH).
- Trial name
- NCT05668754
- Testing
- Serdexmethylphenidate
- Where
- 41 sites in United States
- Volunteers
- 66 people
- Sponsor
- Zevra Therapeutics