NCT06420297

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

A Long-term, Open-label Extension Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: ACADIA Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 5 Years – 30 Years
• Healthy volunteers: Not accepted

Summary

To evaluate long-term safety and tolerability of carbetocin nasal spray (3.2 mg TID) in subjects with PWS

Detailed description

This is a long-term, OLE study to evaluate long-term safety and tolerability of carbetocin nasal spray (3.2 mg TID) in subjects with PWS. Subjects who complete the antecedent double-blind study (ACP-101-302) will be invited to participate in the present study.

Conditions

• Hyperphagia in Prader-Willi Syndrome

Interventions

Type	Name	Description
DRUG	Carbetocin	Carbetocin nasal spray 3.2 mg three times daily (TID)

Timeline

• Start date: 2024-03-11
• Primary completion: 2029-05-01
• Completion: 2029-06-01
• First posted: 2024-05-20
• Last updated: 2025-12-03

Locations

30 sites across 6 countries: United States, Canada, France, Germany, Spain, United Kingdom

Regulatory

• FDA-regulated drug study