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NCT06420297·Phase 3·INTERVENTIONAL

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

CarbetocinOtherEnrolling by invitation

Status

Enrolling by invitation

Phase

Phase 3

Enrollment

160

Locations

30

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Full 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.

Interventions

Treatment arms and agents.

DRUG

Carbetocin

Carbetocin nasal spray 3.2 mg three times daily (TID)

Timeline

From registration to results.

  1. First posted

    May 20, 2024

  2. Study start

    Mar 11, 2024

  3. Primary completion

    May 2029

  4. Study completion

    Jun 2029

  5. Results posted

    Not reported

  6. Registry updated

    Dec 3, 2025

Outcomes

What the study measures.

Primary outcomes

Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), withdrawals due to adverse events (AEs), potentially clinically important changes in other safety assessments, device incidents or device malfunctions

Time frame · Baseline to 36 months

Treatment-emergent adverse events (TEAEs) and device incidents or device malfunctions, TEAEs leading to discontinuation, TEAEs related to study drug, TEAEs by maximum severity, fatal TEAEs, treatment-emergent SAEs, and treatment-emergent SAEs related to study drug will all be summarized for all subjects as well as by previous treatment group.

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
5 Years
Maximum age
30 Years
Sex
ALL
Healthy volunteers
No

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 Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.

Study locations

30 registered sites.

Canada · France · Germany · Spain · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.

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

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

Related trials

More studies on Carbetocin.

Related PeptideStat pages

Put the record in context.

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