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Keep this study
Lead
ACADIA Pharmaceuticals Inc.
This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study comparing carbetocin nasal spray 3.2 mg TID with placebo (matched placebo nasal spray TID) in subjects with PWS.
Age
5–30
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female participants aged 5 to 30 years
Diagnosis of Prader-Willi syndrome with a documented disease-causing genetic mutation
Evidence of hyperphagia, including increased appetite and decreased satiety with food-seeking behaviors
Meeting minimum severity thresholds for hyperphagia based on validated clinical assessments at Screening and Baseline
Residing with a caregiver who is able and willing to comply with study procedures and participate in study visits
You may not be if
Diagnosis of Schaaf-Yang syndrome or another genetic, hormonal, or chromosomal disorder other than Prader-Willi syndrome
Active upper respiratory infection at Screening or Baseline
Clinically significant medical conditions that could interfere with study participation or interpretation of results (e.g., cardiovascular, renal, hepatic, gastrointestinal, or respiratory disease)
History of significant neurological conditions (e.g., cerebrovascular disease, brain trauma, epilepsy, or frequent migraines), except for a history of febrile seizures
Recent or planned nasal surgery that could affect intranasal drug administration
Unwillingness to restrict use of intranasal medications that may interfere with study treatment
Recent clinically significant psychiatric instability, including irritability or agitation requiring changes in antipsychotic therapy
Use of medications or treatments that may interfere with the evaluation of hyperphagia or study endpoints within a defined period prior to Screening Active psychotic disorder or history of significant psychotic symptoms
History of suicide attempt or inpatient psychiatric hospitalization
Recent changes in food-related behavioral or environmental interventions that may confound assessment of hyperphagia
Clareo Health | Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome
