Clinical trial
A Phase 3, Randomized, Double-Blind, Placebo-controlled, Efficacy and Safety Study of Pitolisant Followed by an Open-Label Extension in Patients With Prader-Willi Syndrome
NCT06366464 is registered in ClinicalTrials.gov with Harmony Biosciences Management, Inc. as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- A Phase 3, Randomized, Double-Blind, Placebo-controlled, Efficacy and Safety Study of Pitolisant Followed by an Open-Label Extension in Patients With Prader-Willi Syndrome
- Lead sponsor
- Harmony Biosciences Management, Inc.
- Phase
- Phase 3
- Overall status
- Recruiting
- Start date
- May 28, 2024
- Completion date
- April 30, 2028
- Enrollment
- 134 (estimated)
- Sites
- 57
Conditions
As the registry lists them; a condition with its own page is linked.