Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome
a study on Prader-Willi Syndrome
Summary
- Eligibility
- for people ages 5-30 (full criteria)
- Location
- at UC Irvine
- Dates
- study startedcompletion around
Description
Summary
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
Details
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.
Keywords
Hyperphagia in Prader-Willi Syndrome, Randomized, Placebo-controlled, Prader-Willi Syndrome, Syndrome, Hyperphagia, Carbetocin
Eligibility
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.
Locations
- 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 - Stanford University School of Medicine
accepting new patients
Palo Alto California 94304 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- ACADIA Pharmaceuticals Inc.
- ID
- NCT06173531
- Phase
- Phase 3 Prader-Willi Syndrome Research Study
- Study Type
- Interventional
- Participants
- Expecting 170 study participants
- Last Updated