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Cannabinoid Receptor-1 Blocker

I for Prader-Willi Syndrome (PWS Trial)

Phase 3
Waitlist Available
Led By Roja Motaghedi, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

PWS Trial Summary

The purpose of this study is to evaluate the effect of rimonabant, a cannabinoid receptor-1 blocking drug, on the appetite, body weight, body fat and growth hormone level of subjects with Prader-Willi Syndrome (PWS). This will be a double blind placebo controlled clinical trial involving a total of 18 young adults aged 18 to 35 years with PWS. Patients will be divided in to the two groups of control and intervention, and treated with either placebo (inactive drug), or rimonabant 20 mg once a day for a total duration of 6 months. Body weight, fat distribution, objective and subjective assessment of the hunger, fasting blood sample for measurement of ghrelin and leptin (two hormones regulating appetite), serum lipids , IGF-1(growth hormone related protein), insulin and glucose concentrations will be measured upon enrollment, at 3 months, and at the end of the study. The proportion of body fat to muscle will be determined using a radiological technique, whole body dual-energy x-ray absorptiometry (DEXA) scan, and also by measurement of skin fold thickness, waist and hip circumference at the enrollment prior to the intervention, and at the end of the study.

Eligible Conditions
  • Prader-Willi Syndrome

PWS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Body Weight and Body fat mass
Secondary outcome measures
Lipids

Side effects data

From 2011 Phase 2 trial • 66 Patients • NCT00656487
22%
Headache
17%
Decreased appetite
17%
Nausea
13%
Back pain
9%
Dyspepsia
9%
Fatigue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rimonabant
Placebo
Control

PWS Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: IExperimental Treatment1 Intervention
Subjects receive rimonabant 20 mg per day PO
Group II: IIPlacebo Group1 Intervention
Subjects take placebo capsule one a day PO
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rimonabant
FDA approved

Find a Location

Who is running the clinical trial?

PWSAUSAUNKNOWN
National Institutes of Health (NIH)NIH
2,705 Previous Clinical Trials
7,507,276 Total Patients Enrolled
3 Trials studying Prader-Willi Syndrome
57 Patients Enrolled for Prader-Willi Syndrome
Weill Medical College of Cornell UniversityLead Sponsor
1,055 Previous Clinical Trials
1,316,288 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~1 spots leftby May 2025