Prader-Willi Syndrome study: Pitolisant tablet
Official title A Study of Pitolisant in Patients With Prader-Willi Syndrome
ClinicalTrials.gov ID: NCT06366464
What this study is testing
What is Pitolisant tablet?
an investigational oral tablet being studied as a potential treatment for excessive daytime sleepiness and related symptoms in Prader-Willi syndrome is designed to block histamine H3 receptors, which increases wake‑promoting neurotransmitters in the brain
Also referred to as pitolisant.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out whether pitolisant improves excessive daytime sleepiness and also looks at its effects on behavior, appetite and other symptoms.
- Who it's for
- People who are 6 years old or older and have Prader‑Willi syndrome.
- What's involved
- Participants will be randomly given either pitolisant or a placebo, without knowing which they receive, and will have regular clinic visits for safety checks and questionnaires about sleep and behavior.
- Time commitment
- The trial runs for several months with multiple visits; exact length and visit schedule are set by the study protocol.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 and older
You may be able to join if
- 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...
- In the opinion of the Investigator, the patient/parent(s)/caregiver(s)/legal guardian(s) are capable of understanding and complying with the...
You likely can't join if
- 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 treatment research study involving another investigational medication, device, or behavioral treatment within 30 days or 5...
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- Aurora, Colorado, United States
- Wilmington, Delaware, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Baltimore, Maryland, United States
- Rochester, Minnesota, United States
- Brooklyn, New York, United States
- The Bronx, New York, United States
- Morrisville, North Carolina, United States
- Cleveland, Ohio, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Milwaukee, Wisconsin, United States
- Brisbane, Queensland, Australia
- Camperdown, Australia
- Randwick, Australia
+ 27 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; Sacramento, California, United States; San Diego, California, United States; Aurora, Colorado, United States; Wilmington, Delaware, United States; Atlanta, Georgia, United States and 41 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.