ACTIVE_NOT_RECRUITING

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

Conditions

Hyperphagia in Prader-Willi Syndrome Randomized Placebo-controlled

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

12-week, randomized, double-blind, placebo-controlled, parallel-group study of carbetocin nasal spray for the treatment of hyperphagia in Prader-Willi syndrome (PWS)

Official Title

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome

Quick Facts

Study Start:2023-11-27

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06173531

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years to 30 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* Male or female and 5 through 30 years of age * 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	* Genetically diagnosed with Schaaf-Yang syndrome or another genetic, hormonal, or chromosomal cognitive impairment besides PWS * 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), or tesofensine 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 of the Screening visit

Inclusion Criteria

Exclusion Criteria

* Male or female and 5 through 30 years of age
* 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

* Genetically diagnosed with Schaaf-Yang syndrome or another genetic, hormonal, or chromosomal cognitive impairment besides PWS
* 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), or tesofensine 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 of the Screening visit

Contacts and Locations

Study Locations (Sites)

Children's of Alabama

Birmingham, Alabama, 35233

United States

Phoenix Children's Hospital

Phoenix, Arizona, 85006

United States

University of California Irvine

Orange, California, 92697

United States

Stanford University School of Medicine

Palo Alto, California, 94304

United States

Rady Children's Hospital San Diego

San Diego, California, 92123

United States

Children's Hospital Colorado

Aurora, Colorado, 80045

United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611

United States

University of Iowa

Iowa City, Iowa, 52242

United States

Boston Children's Hospital

Boston, Massachusetts, 02115

United States

Children's Mercy Hospital

Kansas City, Missouri, 64108

United States

SSM Health/Saint Louis University

Saint Louis, Missouri, 63104

United States

Maimonides Medical Center

Brooklyn, New York, 11219

United States

Nationwide Children's Hospital

Columbus, Ohio, 43205

United States

UPMC-Children's Hospital Pittsburgh

Pittsburgh, Pennsylvania, 15224

United States

Vanderbilt Clinical Research Center

Nashville, Tennessee, 37232

United States

Cook Children's Health Care System

Fort Worth, Texas, 79104

United States

Christus Children's

San Antonio, Texas, 78207

United States

University of Utah

Salt Lake City, Utah, 84108

United States

Seattle Children's Hospital

Seattle, Washington, 98105

United States

Collaborators and Investigators

Sponsor: ACADIA Pharmaceuticals Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-27

Study Completion Date2026-06

Study Record Updates

Study Start Date2023-11-27

Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

Randomized
Placebo-controlled

Additional Relevant MeSH Terms

Hyperphagia in Prader-Willi Syndrome