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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, global clinical study to assess the efficacy and safety of pitolisant in patients living with Prader-Willi syndrome. The primary objective of this study is to evaluate the efficacy of pitolisant in treating excessive daytime sleepiness (EDS) in patients ≥6 years of age with Prader-Willi syndrome. Secondary objectives include assessing the impact of pitolisant on: Irritable and disruptive behaviors Hyperphagia Other behavioral problems including social withdrawal, stereotypic behavior, hyperactivity/noncompliance, and inappropriate speech
Study identification
- NCT ID
- NCT06366464
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 134 participants
Conditions and interventions
Conditions
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
- Mar 31, 2027
- Completion
- Mar 31, 2028
- Last update posted
- Aug 24, 2026
2024 – 2028
United States locations
- U.S. sites
- 23
- 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 University Hospital | Baltimore | Maryland | 21205 | 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 |
| Science 37 | 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 33 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 Aug 24, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06366464 live on ClinicalTrials.gov.