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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: Completed Phase 3 study, sponsored by Harmony Biosciences Management.
NCT05458128 is a Phase 3 study that has completed, run by Harmony Biosciences Management. The registered enrollment target is 119 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Incidence of adverse events (AEs)
Interventions
- DRUG Pitolisant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2022-08-19 |
| Est. Completion | 2025-10-01 |
| Phase | Phase 3 |
What the finished NCT05458128 record still lists
NCT05458128 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which Pitolisant is the first listed.
NCT05458128 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05458128's enrollment target sits among peer trials
119 1640th of 2000 higher than 360 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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