A Study of Pitolisant in Patients With Prader-Willi Syndrome
Prader-Willi SyndromeThis 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
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Participation Requirements
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Sex:
ALL -
Eligible Ages:
6 and up
Participation 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
Study Location
Jodha Tishon Inc.
Jodha Tishon Inc.Toronto, Ontario
Canada
Contact Study Team
AMNDX Inc.
AMNDX Inc.Thornhill, Ontario
Canada
Contact Study Team
- Study Sponsored By
- Harmony Biosciences Management, Inc.
- Participants Required
- More Information
- Study ID:
NCT06366464