Study Details
Testing the Study Drug ACP-101 for People with Prader-Willi syndrome
(IRB#: IRB_00171100)
Prader-Willi syndrome (PWS) is caused by a defective gene in a persons body. This causes hyperphagia (extreme hunger) and behavioral symptoms (such as obsessive-compulsive symptoms). This study will test the study drug ACP-101 to treat people with PWS. This study wants to see if the medication will help people and is safe. People in the study will be randomly chosen to be treated with the study drug ACP-101 or a placebo. A placebo looks like the study drug but does not have the medication. The study drug is taken as a nasal (nose) spray. Being in the study requires attending in-person visits at the study clinic. Study participation lasts about 16 weeks. Medical tests will be done during the study to track the health of participants.
- All genders
- All Ages
- Volunteers with special conditions
- In Person
- Paid
Who can participate?
Gender: All genders
Age: All Ages
Volunteers: Volunteers with special conditions
Location: In Person
Inclusion Criteria
- Ages 5 to 30 years and older
- Prader-Willi syndrome (PWS) diagnosis
- On a stable dose of allowed medications for at least 3 months before participation
- Lives with a caregiver who will participate in the study
- Able to attend in-person study visits
Exclusion Criteria
- Pregnant or breastfeeding
- Active upper respiratory infection such as a common cold with a runny nose, sore throat, and cough
- Current or history of brain trauma and other specific conditions that affect the brain
- Severe uncorrected visual or hearing issue
- Major surgery within 1 month before participation
Will I be paid for my time?
Yes
IRB#: IRB_00171100
PI: David Viskochil
Department: PEDIATRICS
Approval Date: 2024-07-03 06:00:00
Specialties: Pediatric Genetics