Status:
RECRUITING
A Study of Pitolisant in Patients With Prader-Willi Syndrome
Lead Sponsor:
Harmony Biosciences Management, Inc.
Conditions:
Prader-Willi Syndrome
Eligibility:
All Genders
6+ years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
The study will consist of an up to 45-day Screening/Baseline Period, a Double-Blind Treatment Period, and an optional Open-Label Extension Period. After completion of all Baseline assessments, patien...
Eligibility Criteria
Inclusion Criteria:
- Genetically confirmed diagnosis of PWS
- Excessive daytime sleepiness
- Has a consistent parent/caregiver (preferably the same person throughout the study) who is willing and able to complete the required study assessments.
- In the opinion of the Investigator, the patient/parent(s)/caregiver(s)/legal guardian(s) are capable of understanding and complying with the requirements of the protocol and administration of oral study drug.
Exclusion Criteria:
- Has a diagnosis of sleep apnea (OSA, CSA) that is not adequately controlled
- Has a diagnosis of hypersomnia due to another sleep/medical disorder
- Participation in an interventional research study involving another investigational medication, device, or behavioral treatment within 30 days or 5 half-lives (whichever is longer) of the investigational medication prior to Screening
Key Trial Info
Start Date :
May 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT06366464
Start Date
May 28 2024
End Date
July 1 2027
Last Update
March 17 2026
Active Locations (54)
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1
Santa Monica Clinical Trials
Los Angeles, California, United States, 90025
2
Center of Excellence in Diabetes and Endocrinology
Sacramento, California, United States, 95821-2123
3
Rady Children's Hospital - Scan Diego
San Diego, California, United States, 92123
4
Colorado Children's Hospital
Aurora, Colorado, United States, 80045