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

Trial Profile

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, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 19 Jun 2025

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At a glance

  • Drugs Carbetocin (Primary)
  • Indications Prader-Willi syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms COMPASS PWS
  • Sponsors Acadia Pharmaceuticals

Most Recent Events

  • 13 Jun 2025 Status changed from recruiting to active, no longer recruiting.
  • 08 May 2025 According to Acadia Pharmaceuticals media release, if results of this trial are positive, the Company anticipates submitting an NDA to the USFDA in Q1 2026.
  • 08 May 2025 According to Acadia Pharmaceuticals media release, as a result of favorable enrollment trends in this trial, the company has accelerated the timing for this study and topline results are now expected in early Q4 2025.

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