OLE Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome
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Phase
Phase 3
Status
Terminated
Study type
Interventional
Design
Na · None · Treatment
Enrollment
168actual
Sites
30
Countries
Canada, France, Germany +3
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Why the sponsor stopped it
Primary efficacy endpoint was not met in the parent study (ACP-101-302). Based on review of available data, continued administration of investigational product in ACP-101-303 was not considered likely to provide significant clinical benefit.
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-03-11 | actual | When the study began enrolling |
| Primary completion | 2025-12-19 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-12-19 | actual | The whole study's end, after follow-up |
| First posted | 2024-05-20 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-17 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Hyperphagia in Prader-Willi Syndrome
Intervention
- Drug: Carbetocin — also filed as ACP-101
Primary outcome
what the primary-completion date above is the date OFTreatment-emergent adverse events (TEAEs), serious adverse events (SAEs), withdrawals due to adverse events (AEs), potentially clinically important changes in other safety assessments, device incidents or device malfunctions
measured Baseline to 36 months
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