Clin2
NCT07348601Possibly a fitRecruiting

Study of CSTI-500 for people with Prader-Willi syndrome

Prader-Willi Syndrome

Part of Brain & nervous system, Genetic & congenital, Hormones & metabolism clinical trials.

This trial tests an investigational drug called CSTI-500 for people with Prader-Willi syndrome who are in the hyperphagia (constant hunger) phase. It aims to see if the drug can improve behavior and reduce overeating. You and your caregiver will need to visit the clinic regularly and answer questions about symptoms.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 2
Enrollment
12 people
Ages
13 years to 50 years
Study type
Interventional

Who can take part

  • Must be 13 to 50 years old and generally healthy.
  • Must have a confirmed genetic diagnosis of Prader-Willi syndrome (not the UPD type) and be in the hyperphagia phase (Nutritional Phase 3).
  • Must have at least a moderate level of behavioral symptoms (CGI-S score 4 or higher) and hyperphagia (HQ-CT total score 13 or higher).
  • Must stop taking most psychiatric medications (like antidepressants, stimulants, or antipsychotics) at least 30 days before starting and not take them during the study.
  • Must have a caregiver who can come to visits, stay with you, and answer questions.
  • Women who can get pregnant must use birth control during the study and for 30 days after.

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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