NCT06173531

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

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: ACADIA Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 5 Years – 30 Years
• Healthy volunteers: Not accepted

Summary

12-week, randomized, double-blind, placebo-controlled, parallel-group study of carbetocin nasal spray for the treatment of hyperphagia in Prader-Willi syndrome (PWS)

Detailed description

This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study comparing carbetocin nasal spray 3.2 mg TID with placebo (matched placebo nasal spray TID) in subjects with PWS.

Conditions

• Hyperphagia in Prader-Willi Syndrome

Interventions

Type	Name	Description
DRUG	Carbetocin	Carbetocin nasal spray 3.2 mg three times daily (TID)
DRUG	Placebo	Placebo given TID, identical in appearance respective to carbetocin treatment

Timeline

• Start date: 2023-11-27
• Primary completion: 2025-10-01
• Completion: 2025-11-01
• First posted: 2023-12-15
• Last updated: 2025-09-10

Locations

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

Regulatory

• FDA-regulated drug study