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A Study of Pitolisant in Patients With Prader-Willi Syndrome

RecruitingPhase 3Ages 6 Years - anyAllHarmony Biosciences Management, Inc.
NCT06366464 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Pitolisant tablet
  • Placebo tablet
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Where

57 sites
Santa Monica Clinical Trials
Los Angeles, United States
Center of Excellence in Diabetes and Endocrinology
Sacramento, United States
Rady Children's Hospital - Scan Diego
San Diego, United States
Colorado Children's Hospital
Aurora, United States
Nemours Children's Hospital
Wilmington, United States
Atlanta Diabetes Associates
Atlanta, United States
Emory University School of Medicine
Atlanta, United States
Rare Disease Research
Atlanta, United States

…and 49 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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