OLE Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome
NCT ID: NCT06420297
Last Updated: 2025-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE3
160 participants
INTERVENTIONAL
2024-03-11
2029-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Drug: Carbetocin
Carbetocin nasal spray 3.2 mg three times daily (TID)
Carbetocin
Carbetocin nasal spray 3.2 mg three times daily (TID)
Interventions
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Carbetocin
Carbetocin nasal spray 3.2 mg three times daily (TID)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
5 Years
30 Years
ALL
No
Sponsors
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ACADIA Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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2023-506201-19-00
Identifier Type: CTIS
Identifier Source: secondary_id
ACP-101-303
Identifier Type: -
Identifier Source: org_study_id
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