Treatment of Hyperphagia in Patients with Prader-Willi Syndrome
Summary: The study will consist of two parts:
Part 1: Two dose levels of XXXX or matching placebo will be administered.
Patients will be randomized in a 1:1:1 ratio to one of the following treatment arms.
Treatment Arm A: XXXX 200 mg administered twice a day (BID) for 12 weeks (n=12)
Treatment Arm B: XXXX 800 mg administered BID for 12 weeks (n=12)
Treatment Arm C: Matching placebo administered BID for 12 weeks (n=12)
Randomization will be stratified by:
• TBD
Following an independent Data and Safety Monitoring Committee (DSMC) review, the study will continue with one active dose level per DSMC recommendation.
Part 2: One dose level of XXXX or matching placebo will be administered.
Patients will be randomized in a 1:1 ratio to one of the following treatment arms.
Treatment Arm A: DSMC recommended XXXX dose administered BID for 12 weeks (n=57)
Treatment Arm B: Matching placebo administered BID for 12 weeks (n=57)
Type of study (PIC, Recruiting): Recruiting
Commercial Study - Site Identification form required to be completed, please find Site ID form uploaded to study documents link below.
Recruitment Duration: 16/12/2024 - 15/08/2025
Practice Activity: See part B and Schedule of Events
Practice Eligibility Criteria: GP practices within East Midlands
Practice Target: None at this time
Is this Study Applicable for RSI Scheme?
Yes, applicable for RSI scheme