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NCT05156047 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia
A Phase 3 study, sponsored by Harmony Biosciences Management.
- Completed
- Registry status
- Phase 3
- Development phase
- 214
- Enrollment target
NCT05156047 is a Phase 3 study that has completed, run by Harmony Biosciences Management. The registered enrollment target is 214 participants.
The verdict
NCT05156047, a Phase 3 study, has completed, sponsored by Harmony Biosciences Management.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 214 participants
- Enrollment target
Study Summary
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 patients with idiopathic hypersomnia (IH) age ≥18 years. Key secondary objectives of this study are to assess the impact of pitolisant on: * Overall symptoms of IH * Patient impression of overall change in their symptoms of IH * Investigator assessment of overall disease severity of IH Other secondary objectives of this study are to assess the impact of pitolisant in patients with IH on: * Patient impression of overall severity of their EDS * Functional status and activities of daily living * Sleep-related impairment * Sleep inertia * Cognitive function
Interventions
- DRUG Open-label pitolisant
- DRUG Double-blind placebo
- DRUG Double-blind pitolisant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 214 participants |
| Start Date | 2022-05-25 |
| Est. Completion | 2023-09-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05156047
The ClinicalTrials.gov registry entry for NCT05156047 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 214 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Harmony Biosciences Management, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Open-label pitolisant is the first listed.
NCT05156047 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05156047 about?
NCT05156047 is a clinical study titled "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 patients with idiopathic hypersomnia (IH) age ≥18 years. Key secondary objectives of this study are to assess the impact of pitolisant on:...
What is the current status of trial NCT05156047?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 214 participants. The study started on 2022-05-25. Estimated completion is 2023-09-08.
What interventions are being tested in trial NCT05156047?
The interventions under investigation include: Open-label pitolisant (DRUG), Double-blind placebo (DRUG), Double-blind pitolisant (DRUG).
Who is sponsoring clinical trial NCT05156047?
This trial is sponsored by Harmony Biosciences Management, which has 10 total clinical trials registered on ClinicalTrials.gov.
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