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Hormone Therapy

Carbetocin 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up score at week 12
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline at Week 12 in caregiver-rated Hyperphagia Questionnaire for Clinical Trials (HQ-CT) score
Secondary outcome measures
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
46 Previous Clinical Trials
10,770 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you elaborate on the security of Carbetocin for human use?

"The safety of Carbetocin has been supported by ample clinical research, thus our team gave the drug a score of 3."

Answered by AI

Does this trial accept applicants aged 50 and above?

"This clinical trial is exclusively for participants aged 5 to 30. Patients below the age of 18 have 379 other studies available, and those older than 65 can access 1039 different trials."

Answered by AI

Is enrollment open for this research project?

"Unfortunately, the clinical trial hosted on clinicaltrials.gov does not currently have any openings for enrolment. The original posting was on November 27th 2023 and last modified December 8th of the same year. However, 1472 other trials are actively recruiting participants at this time."

Answered by AI

To whom is this experiment open for participation?

"A prerequisite for entry into this research trial is a diagnosis of Prader-Willi Syndrome, and being aged between 5 to 30. 170 people will be admitted in total."

Answered by AI

Who else is applying?

What site did they apply to?
Stanford University School of Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome
2023. "Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06173531.
All > Kansas City > Binge Eating
~113 spots leftby May 2026
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