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OLE Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome | Clinical Trials | Clareo Health

ENROLLING_BY_INVITATIONPHASE3

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

NCT06420297•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

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.

Eligibility

Age

5 - 30 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Has completed the Week12/EOT visit of the antecedent, Study ACP-101-302
•Met all entry criteria for the antecedent study
•May benefit from long-term treatment with open-label carbetocin in the judgment of the Investigator.
•Lives with a caregiver who understands and is willing and able to adhere to study-related procedures and is willing to participate in all study visits.

Exclusion Criteria

•History of, or current, cerebrovascular disease, brain trauma, epilepsy, or frequent migraines. A history of febrile seizures is not exclusionary.
•Active psychotic symptoms, a history of psychotic symptoms, or a psychotic disorder
•History of suicide attempt or inpatient psychiatric hospitalization
•Has a clinically significant abnormality in vital signs at Baseline
•Has an average QTcF interval of \>450 ms on the Baseline ECG performed before the first dose of carbetocin is given in the present study (i.e., the ECG performed at the EOT visit of the antecedent study)
•Has developed a clinically significant ECG finding during the antecedent study
•Subject is judged by the Investigator or the Medical Monitor to be inappropriate for the study due to AEs, medical condition, or noncompliance with investigational product or study procedures in the antecedent study

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

Key Dates

Start Date

March 11, 2024

Primary Completion Date

May 1, 2029

Completion Date

June 1, 2029

Last Updated

December 3, 2025

Enrollment

160

ESTIMATED participants

Conditions

Hyperphagia in Prader-Willi Syndrome

Interventions

Carbetocin

DRUG

The Hunger Elimination or Reduction Objective (HERO ) Open -Label Extension (OLE) Trial

NCT07197034

HyperphagiaPrader-Willi Syndrome+1 more

View study

COMPLETEDPHASE2

Treatment of Hyperphagia Behavioral Symptoms in Children and Adults Diagnosed With Prader-Willi Syndrome

NCT01968187

Hyperphagia in Prader-Willi Syndrome

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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