Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome
NCT ID: NCT06173531
Last Updated: 2025-09-10
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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ACTIVE_NOT_RECRUITING
PHASE3
170 participants
INTERVENTIONAL
2023-11-27
2025-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Carbetocin
Carbetocin nasal spray 3.2 mg three times daily (TID)
Carbetocin
Carbetocin nasal spray 3.2 mg three times daily (TID)
Placebo
Placebo
Placebo
Placebo given TID, identical in appearance respective to carbetocin treatment
Interventions
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Carbetocin
Carbetocin nasal spray 3.2 mg three times daily (TID)
Placebo
Placebo given TID, identical in appearance respective to carbetocin treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Prader-Willi syndrome with a documented disease-causing mutation
* Increased appetite with decreased satiety accompanied by food seeking (consistent with PWS Nutritional Phase 3)
* HQ-CT total score of ≥13 at Screening and Baseline
* CGI-S score for hyperphagia in PWS of ≥4 at Screening and Baseline
* 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
* An active upper respiratory infection at the Screening visit or the Baseline visit
* Any clinically significant cardiovascular disorder, renal, hepatic, gastrointestinal, or respiratory disease, including severe asthma
* History of, or current, cerebrovascular disease, brain trauma, epilepsy, or frequent migraines. A history of febrile seizures is not exclusionary
* Nasal surgery within 1 month of Screening visit or planning to have nasal surgery during the study.
* Unwilling to abstain from nasal saline, other nasal irrigation, and other intranasal medications during the Screening period and through the treatment period of the study
* Clinically significant irritability or agitation, requiring initiation of or increase in the dose of antipsychotic medication, within the 6 months prior to the Screening visit
* Used prostaglandins, prostaglandin analogues, or prostaglandin agonists in the 3 months prior to the Baseline visit. Inhibitors of prostaglandin synthesis, such as nonsteroidal anti-inflammatory drugs, are not exclusionary.
* Started a glucagon-like peptide 1 (GLP-1) agonist within the 6 months prior to the Screening visit. Treatment with GLP-1 agonist is allowed if the subject has been taking it for more than 6 months prior to Screening.
* Used oxytocin, desmopressin (DDAVP), tesofensine, diazoxide choline, melanocortin-4 receptor (MC4R) agonists (e.g., setmelanotide), or any medication approved to treat hyperphagia within 6 months prior to the Baseline visit
* Active psychotic symptoms, a history of psychotic symptoms, or a psychotic disorder
* History of suicide attempt or inpatient psychiatric hospitalization
* New food-related interventions, including environment or dietary restrictions, within 1 month prior to the Screening visit or during the Screening period (i.e., before the Baseline visit)
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 Hospital
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 - Hôpital des Enfants
Toulouse, , 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 Research Facility
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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2023-506200-24-00
Identifier Type: CTIS
Identifier Source: secondary_id
ACP-101-302
Identifier Type: -
Identifier Source: org_study_id
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