Effect of Rimonabant on Weight Gain and Body Composition in Adults With Prader Willi Syndrome

NCT ID: NCT00603109

Last Updated: 2023-03-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2009-01-31

Brief 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.

Conditions

Prader-willi Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

I

Subjects receive rimonabant 20 mg per day PO

Group Type: EXPERIMENTAL

rimonabant

Intervention Type: DRUG

rimonabant capsule 20 mg per day PO for 6 months

II

Subjects take placebo capsule one a day PO

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Subjects take 20 mg placebo capsule one a day PO for 6 months

Interventions

rimonabant

rimonabant capsule 20 mg per day PO for 6 months

Intervention Type: DRUG

placebo

Subjects take 20 mg placebo capsule one a day PO for 6 months

Intervention Type: DRUG

Other Intervention Names

Acomplia

Eligibility Criteria

Inclusion Criteria

1. Subjects will be selected if they have Prader Willi Syndrome previously confirmed by standard genetic testing (the DNA methylation test) or meet the clinical diagnostic criteria as follows :the presence of at least four of the six principal characteristics of PWS syndrome including 1) infantile hypotonia, 2) abnormal pubertal development, 3) obesity after early infancy, 4) dysfunctional central nervous system performance, 5) dysmorphic facial features, and 6) short stature. In addition, they must have one or more of the following characteristics commonly associated with PWS: 1) small hands and feet, 2) skin problems, 3) behavioral problems related to food, and 4) decreased pain sensitivity.

2. Subjects must be 18 to 35 years of age and fairly cooperative with the study protocol.

3. Subjects must have a BMI of at least 30 or more.

Exclusion Criteria

1. Presence of pulmonary disease.

2. Presence of any other abnormal endocrine findings, including abnormal thyroid function.

4. Subjects with Prader Willi Syndrome who are on other medications including growth hormone therapy, anti epileptic medications, or antipsychotic medications.

5. The presence of moderate to severe renal or liver disease. Mild elevations of liver enzymes are not exclusive.

6. Subjects who are on any other research or weight loss medication

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

PWSAUSA

UNKNOWN

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roja Motaghedi, MD

Role: PRINCIPAL_INVESTIGATOR

NYPH-Weill Cornell Medical College

Moris Angulo, MD

Role: PRINCIPAL_INVESTIGATOR

Winthrop University Hospital

Locations

New York Presbyterian Hospital-Weill Cornell Medical College

New York, New York, United States

Countries

United States

References

Deal CL, Tony M, Hoybye C, Allen DB, Tauber M, Christiansen JS; 2011 Growth Hormone in Prader-Willi Syndrome Clinical Care Guidelines Workshop Participants. GrowthHormone Research Society workshop summary: consensus guidelines for recombinant human growth hormone therapy in Prader-Willi syndrome. J Clin Endocrinol Metab. 2013 Jun;98(6):E1072-87. doi: 10.1210/jc.2012-3888. Epub 2013 Mar 29.

Reference Type: BACKGROUND

PMID: 23543664 (View on PubMed)

Motaghedi R, Lipman EG, Hogg JE, Christos PJ, Vogiatzi MG, Angulo MA. Psychiatric adverse effects of rimonobant in adults with Prader Willi syndrome. Eur J Med Genet. 2011 Jan-Feb;54(1):14-8. doi: 10.1016/j.ejmg.2010.09.015. Epub 2010 Oct 20.

Reference Type: RESULT

PMID: 20965292 (View on PubMed)

Other Identifiers

0611008841

Identifier Type: -

Identifier Source: org_study_id