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NCT05458128 · ClinicalTrials.gov registry record · Phase 3
A Long-Term Safety and Effectiveness Study to Evaluate Pitolisant in Adult Patients With Idiopathic Hypersomnia
A Phase 3 study, sponsored by Harmony Biosciences Management.
- Completed
- Registry status
- Phase 3
- Development phase
- 119
- Enrollment target
NCT05458128 is a Phase 3 study that has completed, run by Harmony Biosciences Management. The registered enrollment target is 119 participants.
The verdict
NCT05458128, a Phase 3 study, has completed, sponsored by Harmony Biosciences Management.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 119 participants
- Enrollment target
Study Summary
The primary objective of this study is to assess the long-term safety and effectiveness of pitolisant in patients with idiopathic hypersomnia (IH) who completed the Double-Blind Randomized Withdrawal Phase of study HBS-101-CL-010.
Interventions
- DRUG Pitolisant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2022-08-19 |
| Est. Completion | 2025-10-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05458128
The ClinicalTrials.gov registry entry for NCT05458128 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 119 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 1 intervention - of which Pitolisant is the first listed.
NCT05458128 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05458128 about?
NCT05458128 is a clinical study titled "A Long-Term Safety and Effectiveness Study to Evaluate Pitolisant in Adult Patients With Idiopathic Hypersomnia". The primary objective of this study is to assess the long-term safety and effectiveness of pitolisant in patients with idiopathic hypersomnia (IH) who completed the Double-Blind Randomized Withdrawal Phase of study HBS-101-CL-010.
What is the current status of trial NCT05458128?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 119 participants. The study started on 2022-08-19. Estimated completion is 2025-10-01.
What interventions are being tested in trial NCT05458128?
The interventions under investigation include: Pitolisant (DRUG).
Who is sponsoring clinical trial NCT05458128?
This trial is sponsored by Harmony Biosciences Management, which has 10 total clinical trials registered on ClinicalTrials.gov.
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