This study is testing a medication called pitolisant to see if it can help people aged 6 and older with Prader-Willi syndrome who experience excessive daytime sleepiness. Researchers also want to see if pitolisant can improve irritable behaviors, hyperphagia (extreme hunger), and other behavioral problems. You may be able to join if you have a confirmed diagnosis of Prader-Willi syndrome and excessive daytime sleepiness. The main way success will be measured is by looking at changes in how severe your sleepiness is, as reported by you. The current status of this study is unclear, but it plans to enroll 134 participants.

Study design

This is a Phase 3, randomized, double-blind (meaning neither you nor your doctor will know if you're receiving the study drug or placebo), placebo-controlled study. You will either receive pitolisant or a placebo tablet.

What's involved

After an initial screening period of up to 45 days, you will receive either pitolisant or placebo for a "Double-Blind Treatment Period" with in-person visits on Day 29, Day 57, and Day 77. There is also an optional "Open-Label Extension Period" with additional visits.

Compensation

Not stated in the trial record.

Follow-up

If you do not enter the optional Open-Label Extension Period, there will be follow-up visits 15 and 30 days after your last dose of the study drug. If you enter the Open-Label Extension, there will be follow-up visits 15 and 30 days after your final dose of pitolisant.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.