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Hormone Therapy

Carbetocin Nasal Spray for Prader-Willi Syndrome

Phase 3
Recruiting
Research Sponsored by ACADIA Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female and 5 through 30 years of age
Prader-Willi syndrome with a documented disease-causing mutation
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up score at week 12
Awards & highlights

Summary

This trial tested a nasal spray to treat overeating in Prader-Willi Syndrome, a genetic disorder. It was randomized, double-blind, and placebo-controlled.

Who is the study for?
This trial is for males and females aged 5-30 with Prader-Willi syndrome, experiencing intense hunger and food-seeking behavior. Participants must have a caregiver able to follow study procedures. Exclusions include other cognitive impairments, recent nasal surgery, severe respiratory diseases, use of certain medications like prostaglandins or oxytocin recently, and new dietary interventions within the last month.
What is being tested?
The study tests Carbetocin nasal spray against a placebo over 12 weeks to see if it can reduce excessive eating (hyperphagia) in those with Prader-Willi syndrome. It's randomized and double-blind, meaning neither participants nor researchers know who gets the real treatment versus the placebo.
What are the potential side effects?
While specific side effects are not listed here, typical nasal spray reactions may include irritation or discomfort in the nose, sneezing, runny nose or congestion. Systemic side effects could potentially arise from carbetocin's action similar to oxytocin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 5 and 30 years old.
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I have Prader-Willi syndrome with a confirmed genetic mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I currently have an upper respiratory infection.
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I do not have any serious heart, kidney, liver, stomach, or lung conditions.
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I have a genetic condition affecting my cognitive abilities, not including Prader-Willi syndrome.
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I have not had nasal surgery in the last month and do not plan to during the study.
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I am willing to stop using nasal treatments during the study.
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I needed more medication for irritability or agitation in the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~score at week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and score at week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from Baseline at Week 12 in caregiver-rated Hyperphagia Questionnaire for Clinical Trials (HQ-CT) score
Secondary study objectives
Change from Baseline at Week 12 in caregiver-rated Clinical Global Impression-Severity (CGI-S) score for PWS
Clinical Global Impression-Change (CGI-C) for PWS score at Week 12

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CarbetocinExperimental Treatment1 Intervention
Carbetocin nasal spray 3.2 mg three times daily (TID)
Group II: PlaceboPlacebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carbetocin
2019
Completed Phase 4
~8290

Find a Location

Who is running the clinical trial?

ACADIA Pharmaceuticals Inc.Lead Sponsor
47 Previous Clinical Trials
11,426 Total Patients Enrolled
1 Trials studying Prader-Willi Syndrome
160 Patients Enrolled for Prader-Willi Syndrome
~111 spots leftby May 2026
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