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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

170

Participants

Timeline

Start Date

November 27, 2023

Primary Completion Date

October 31, 2025

Study Completion Date

November 30, 2025

Conditions
Hyperphagia in Prader-Willi Syndrome
Interventions
DRUG

Carbetocin

Carbetocin nasal spray 3.2 mg three times daily (TID)

DRUG

Placebo

Placebo given TID, identical in appearance respective to carbetocin treatment

Trial Locations (30)

11219

Maimonides Medical Center, Brooklyn

15224

UPMC-Children's Hospital Pittsburgh, Pittsburgh

28009

Hospital General Universitario Gregorio Marañón, Madrid

29010

Hospital Regional Universitario de Málaga, Málaga

31059

Centre Hospitalier Universitaire (CHU) de Toulouse - Hôpital des Enfants, Toulouse

35233

Children's of Alabama, Birmingham

37232

Vanderbilt Clinical Research Center, Nashville

43205

Nationwide Children's Hospital, Columbus

45147

Universitätsklinikum Essen, Essen

52242

University of Iowa, Iowa City

60611

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

63104

SSM Health/Saint Louis University, St Louis

64108

Children's Mercy Hospital, Kansas City

78207

Christus Children's, San Antonio

79104

Cook Children's Health Care System, Fort Worth

80045

Children's Hospital Colorado, Aurora

84108

University of Utah, Salt Lake City

85006

Phoenix Children's Hospital, Phoenix

86154

KJF Klinik Josefinum gGmbH, Augsburg

92123

Rady Children's Hospital San Diego, San Diego

92697

University of California Irvine, Orange

94304

Stanford University School of Medicine, Palo Alto

98105

Seattle Children's Hospital, Seattle

02115

Boston Children's Hospital, Boston

T6G 2E1

Alberta Diabetes Institute, Edmonton

H3T 1C5

CHU Sainte Justine, Montreal

08208

Parc Taulí Hospital Universitari, Barcelona

B9 5SS

University Hospitals Birmingham NHS Foundation Trust - Heartlands Hospital, Birmingham

G51 4TF

Royal Hospital for Children Glasgow Clinical Research Facility, Glasgow

E1 1BB

Barts Health NHS Trust - The Royal London Hospital, London

Sponsors
All Listed Sponsors
lead

ACADIA Pharmaceuticals Inc.

INDUSTRY