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Carbetocin · 1 trial · 1 indication
The HQ-CT is a nine-item questionnaire designed to be completed by caregivers of subjects with PWS. It is a revision of the 11-item HPWSQ-R and has been further validated. The Foundation for Prader-Willi Research has made the HQ-CT available for clinical studies in PWS, and it is the consensus instrument within the PWS research community for measuring observable behaviors that stem from subjects' excessive drive to eat. The HQ-CT should be completed by the same caregiver throughout the study. The HQ-CT will be administered to the caregiver by a rater using standardized prompts. The Food Safe Zone should be administered immediately before administration of the HQ-CT. A higher score on the HQ-CT indicates greater severity of hyperphagia.
| Arm | Type | Description |
|---|---|---|
| Carbetocin | EXPERIMENTAL | Carbetocin nasal spray 3.2 mg three times daily (TID) |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| Carbetocin | DRUG | Carbetocin nasal spray 3.2 mg three times daily (TID) |
| Placebo | DRUG | Placebo given TID, identical in appearance respective to carbetocin treatment |
Inclusion Criteria * 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...
Carbetocin is an investigational small molecule being developed for the treatment of hyperphagia in Prader-Willi Syndrome. Hyperphagia is a hallmark symptom of the condition characterized by an insatiable appetite. Carbetocin is administered as a nasal spray and is currently in Phase 3 clinical development.
Carbetocin is a synthetic analog of oxytocin, a hormone involved in social bonding and appetite regulation. It is designed to target pathways related to hyperphagia in Prader-Willi Syndrome, potentially reducing the excessive hunger and food-seeking behaviors associated with the condition. The exact mechanism is under investigation in clinical trials.
Carbetocin is being developed by ACADIA Pharmaceuticals Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ACAD. ACADIA is conducting a Phase 3 clinical trial to evaluate the safety and efficacy of Carbetocin nasal spray for hyperphagia in Prader-Willi Syndrome.
Carbetocin is in Phase 3 clinical development for the treatment of hyperphagia in Prader-Willi Syndrome. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 3 trial is active but not recruiting participants, with an enrollment target of 170 patients.
Carbetocin is being studied in a Phase 3 clinical trial with the identifier NCT06173531, titled 'Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome.' The trial is randomized, double-blind, and placebo-controlled, enrolling 170 participants aged 5 years and older across the United States, Canada, France, Germany, Spain, and the United Kingdom.