for people ages 5-30 (full criteria)
at Orange, California and other locations
study started
completion around



12-week, randomized, double-blind, placebo-controlled, parallel-group study of carbetocin nasal spray for the treatment of hyperphagia in Prader-Willi syndrome (PWS)

Official Title

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome


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.


Hyperphagia in Prader-Willi Syndrome, Randomized, Placebo-controlled, Prader-Willi Syndrome, Syndrome, Hyperphagia, Carbetocin


You can join if…

Open to people ages 5-30

  • Male or female and 5 through 30 years of age
  • Prader-Willi syndrome with a documented disease-causing mutation
  • Increased appetite with decreased satiety accompanied by food seeking (consistent with PWS Nutritional Phase 3)
  • HQ-CT total score of ≥13 at Screening and Baseline
  • CGI-S score for hyperphagia in PWS of ≥4 at Screening and Baseline
  • Lives with a caregiver who understands and is willing and able to adhere to study-related procedures and is willing to participate in all study visits

You CAN'T join if...

  • Genetically diagnosed with Schaaf-Yang syndrome or another genetic, hormonal, or chromosomal cognitive impairment besides PWS
  • An active upper respiratory infection at the Screening visit or the Baseline visit
  • Any clinically significant cardiovascular disorder, renal, hepatic, gastrointestinal, or respiratory disease, including severe asthma
  • History of, or current, cerebrovascular disease, brain trauma, epilepsy, or frequent migraines. A history of febrile seizures is not exclusionary
  • Nasal surgery within 1 month of Screening visit or planning to have nasal surgery during the study.
  • Unwilling to abstain from nasal saline, other nasal irrigation, and other intranasal medications during the Screening period and through the treatment period of the study
  • Clinically significant irritability or agitation, requiring initiation of or increase in the dose of antipsychotic medication, within the 6 months prior to the Screening visit
  • Used prostaglandins, prostaglandin analogues, or prostaglandin agonists in the 3 months prior to the Baseline visit. Inhibitors of prostaglandin synthesis, such as nonsteroidal anti-inflammatory drugs, are not exclusionary.
  • Started a glucagon-like peptide 1 (GLP-1) agonist within the 6 months prior to the Screening visit. Treatment with GLP-1 agonist is allowed if the subject has been taking it for more than 6 months prior to Screening.
  • Used oxytocin, desmopressin (DDAVP), or tesofensine within 6 months prior to the Baseline visit
  • Active psychotic symptoms, a history of psychotic symptoms, or a psychotic disorder
  • History of suicide attempt or inpatient psychiatric hospitalization
  • New food-related interventions, including environment or dietary restrictions, within 1 month of the Screening visit

Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.


  • University of California Irvine accepting new patients
    Orange California 92697 United States
  • Rady Children's Hospital San Diego accepting new patients
    San Diego California 92123 United States


accepting new patients
Start Date
Completion Date
ACADIA Pharmaceuticals Inc.
Phase 3 Prader-Willi Syndrome Research Study
Study Type
Expecting 170 study participants
Last Updated