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NCT06420297 · ClinicalTrials.gov record · last posted 2026-08-17

OLE Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome

StatusTerminated
PhasePhase 3
Started2024-03-11
View on ClinicalTrials.gov ↗
Why the trial stopped
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.
from the ClinicalTrials.gov record
To evaluate long-term safety and tolerability of carbetocin nasal spray (3.2 mg TID) in subjects with PWS

Protocol amendment history 4 changes detected by DataLookout

2026-08-18
Trial status changed: Enrolling by Invitation → Terminated
2026-08-18
Trial terminated: Primary efficacy endpoint was not met in the parent study (ACP-101-302). Based on review of available data, continued a...
2026-08-18
Primary completion moved earlier: 2029-05 → 2025-12-19
2026-08-18
Completion moved earlier: 2029-06 → 2025-12-19
Trial Details
NCT Number NCT06420297
Lead Sponsor ACADIA Pharmaceuticals Inc.
Conditions Hyperphagia in Prader-Willi Syndrome
Enrollment 168 participants
Start Date 2024-03-11
Primary Completion 2025-12-19 (estimated)
Study Completion 2025-12-19 (estimated)
Updated on ClinicalTrials.gov 2026-08-17