Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06420297 | OLE Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome | PHASE3 | ENROLLING BY_INVITATION | 160 | — | — | Mar 11, 2024 | Jun 1, 2029 | Dec 3, 2025 | 30 | United States, Canada +4 |
| NCT06173531 | Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome | PHASE3 | ACTIVE NOT_RECRUITING | 170 | — | — | Nov 27, 2023 | Nov 1, 2025 | Sep 10, 2025 | 30 | United States, Canada +4 |
Treatment-emergent adverse events (TEAEs) and device incidents or device malfunctions, TEAEs leading to discontinuation, TEAEs related to study drug, TEAEs by maximum severity, fatal TEAEs, treatment-emergent SAEs, and treatment-emergent SAEs related to study drug will all be summarized for all subjects as well as by previous treatment group.
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 |
|---|---|---|
| Drug: Carbetocin | EXPERIMENTAL | Carbetocin nasal spray 3.2 mg three times daily (TID) |
| 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: * Has completed the Week12/EOT visit of the antecedent, Study ACP-101-302 * Met all entry criteria for the antecedent study * May benefit from long-term treatment with open-label carbetocin in the judgment of the Investigator. * Lives with a caregiver who understands and is will...