A Phase 2 Study to Evaluate the Safety and Efficacy of Pitolisant in Patients With Prader-Willi Syndrome, Followed by an Open Label Extension
Public ClinicalTrials.gov record NCT04257929. 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 Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Pitolisant in Patients With Prader-Willi Syndrome, Followed by an Open Label Extension
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this study is to evaluate the safety and efficacy of pitolisant compared with placebo in treating excessive daytime sleepiness (EDS) in patients with Prader Willi syndrome (PWS) ages 6 to 65 years.
Study identification
- NCT ID
- NCT04257929
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 65 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Years to 65 Years
- 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
- Dec 9, 2020 (Actual)
- Primary completion
- Aug 17, 2022 (Actual)
- Completion
- Jan 21, 2026 (Actual)
- Last update posted
- May 12, 2026
2020 – 2026
United States locations
- U.S. sites
- 13
- U.S. states
- 10
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Rady Children's Hospital - San Diego | San Diego | California | 92123 | — |
| Sleep Medicine Specialists of California | San Ramon | California | 94583 | — |
| Santa Monica Clinical Trials | Santa Monica | California | 90404 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Nemours Alfred I duPont Hospital for Children | Wilmington | Delaware | 19803 | — |
| University of Florida College of Medicine | Gainesville | Florida | 32608 | — |
| Ann and Robert H Lurie Children's Hospital | Chicago | Illinois | 60611 | — |
| Johns Hopkins School of Medicine | Baltimore | Maryland | 21205 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68114 | — |
| CTI | Cincinnati | Ohio | 45212 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37203 | — |
| Texas Children's Hospital/Baylor College of Medicine | Houston | Texas | 77030 | — |
| Road Runner Research | San Antonio | Texas | 78249 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04257929, 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 May 12, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04257929 live on ClinicalTrials.gov.