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ENROLLING BY INVITATION
NCT06420297
PHASE3

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

Sponsor: ACADIA Pharmaceuticals Inc.

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

All

Age Range

5 Years - 30 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2024-03-11

Completion Date

2029-06

Last Updated

2025-12-03

Healthy Volunteers

No

Interventions

DRUG

Carbetocin

Carbetocin nasal spray 3.2 mg three times daily (TID)

Locations (30)

Children's of Alabama

Birmingham, Alabama, United States

Phoenix Children's Hospital

Phoenix, Arizona, United States

University of California Irvine

Orange, California, United States

Stanford University School of Medicine

Palo Alto, California, United States

Rady Children's Hospital San Diego

San Diego, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

University of Iowa

Iowa City, Iowa, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Children's Mercy Kansas City

Kansas City, Missouri, United States

SSM Health/Saint Louis University

St Louis, Missouri, United States

Maimonides Medical Center

Brooklyn, New York, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

UPMC-Children's Hospital Pittsburgh

Pittsburgh, Pennsylvania, United States

Vanderbilt Clinical Research Center

Nashville, Tennessee, United States

Cook Children's Health Care System

Fort Worth, Texas, United States

Christus Children's

San Antonio, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Seattle Children's Hospital

Seattle, Washington, United States

Alberta Diabetes Institute

Edmonton, Alberta, Canada

CHU Sainte-Justine

Montreal, Quebec, Canada

Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital des Enfants

Toulouse, Cedex 9 Occitanie, France

KJF Klinik Josefinum gGmbH

Augsburg, Germany

Universitätsklinikum Essen

Essen, Germany

Parc Taulí Hospital Universitari

Barcelona, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Hospital Regional Universitario de Málaga

Málaga, Spain

University Hospitals Birmingham NHS Foundation Trust - Heartlands Hospital

Birmingham, United Kingdom

Royal Hospital for Children Glasgow Clinical

Glasgow, United Kingdom

Barts Health NHS Trust - The Royal London Hospital

London, United Kingdom