A Study of Pitolisant in Patients With Prader-Willi Syndrome
Public ClinicalTrials.gov record NCT06366464. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official 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
Study identification
- NCT ID
- NCT06366464
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Harmony Biosciences Management, Inc.
- Industry
- Enrollment
- 134 participants
Conditions and interventions
Conditions
Interventions
- Pitolisant tablet Drug
- Placebo tablet Other
Drug · Other
Eligibility (public fields only)
- Age range
- 6 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 27, 2024
- Primary completion
- Jun 30, 2026
- Completion
- Jun 30, 2027
- Last update posted
- Mar 16, 2026
2024 – 2027
United States locations
- U.S. sites
- 21
- U.S. states
- 13
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Santa Monica Clinical Trials | Los Angeles | California | 90025 | Recruiting |
| Center of Excellence in Diabetes and Endocrinology | Sacramento | California | 95821-2123 | Recruiting |
| Rady Children's Hospital - Scan Diego | San Diego | California | 92123 | Recruiting |
| Colorado Children's Hospital | Aurora | Colorado | 80045 | Recruiting |
| Nemours Children's Hospital | Wilmington | Delaware | 19803-3607 | Recruiting |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30318 | Withdrawn |
| Emory University School of Medicine | Atlanta | Georgia | 30322 | Recruiting |
| Rare Disease Research | Atlanta | Georgia | 30329 | Withdrawn |
| Ann And Robert H Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | Recruiting |
| Riley Children's Hospital | Indianapolis | Indiana | 46202 | Recruiting |
| Johns Hopkins Hospital | Baltimore | Maryland | 21224 | Recruiting |
| Mayo Clinic-PPDS | Rochester | Minnesota | 55905 | Recruiting |
| Maimonides Medical Center | Brooklyn | New York | 11219 | Recruiting |
| Montefiore Medical Center | The Bronx | New York | 10467 | Recruiting |
| Science 37 (at-home option) | Morrisville | North Carolina | 27560 | Recruiting |
| CTI Clinical Research Center | Cincinnati | Ohio | 45212 | Withdrawn |
| Center for Human Genetics | Cleveland | Ohio | 441016 | Recruiting |
| Texas Children's Hospital | Houston | Texas | 77030 | Recruiting |
| Road Runner Research | San Antonio | Texas | 78249-3539 | Recruiting |
| Texas Valley Clinical Research | Weslaco | Texas | 78596 | Terminated |
| Childrens Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 32 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06366464, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 16, 2026 · Synced Apr 29, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06366464 live on ClinicalTrials.gov.