OLE Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome
Enrolling by invitation · Phase 3
Conditions studied: Hyperphagia in Prader-Willi Syndrome
In brief
To evaluate long-term safety and tolerability of carbetocin nasal spray (3.2 mg TID) in subjects with PWS
Key facts
- Study ID
- NCT06420297
- Run by
- ACADIA Pharmaceuticals Inc.
- People needed
- 160
- Starts
- 2024-03-11
- Expected to finish
- 2029-06-01
- Last updated by the study team
- 2025-12-03
Who can join
Age: 5 and older, up to 30. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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