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A Study of Pitolisant in Patients With Prader-Willi Syndrome

Join a Pitolisant study for Prader-Willi Syndrome patients.

Recruiting
6 years and older
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Phase 3
Study of Pitolisant in Prader-Willi Syndrome

This study examines pitolisant, a medicine for Prader-Willi syndrome (PWS), a genetic disorder that affects many parts of the body. The study checks if pitolisant helps with excessive daytime sleepiness (EDS) in children aged 6 and older with PWS. It also looks at how pitolisant affects other problems like irritability, eating too much, and behavior issues.

Participants will have different phases: a Screening/Baseline phase of up to 45 days, a Double-Blind Treatment Period where neither doctors nor patients know who gets the real medicine or a placebo (a fake treatment), and an optional Open-Label Extension Period where all get the real medicine. Visits are needed on specific days throughout the study.

  • The study involves several visits, including optional follow-up periods.
  • Participants must have PWS and EDS and a caregiver to help with study tasks.
  • People with uncontrolled sleep apnea or other sleep disorders can't join.
Study details
    Prader-Willi Syndrome

NCT06366464

Harmony Biosciences Management, Inc.

14 June 2025

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What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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