Effect of Rimonabant on Weight Gain and Body Composition in Adults With Prader Willi Syndrome - Full Text View

Sponsors and Collaborators:	Weill Medical College of Cornell University National Institutes of Health (NIH) PWSAUSA
Information provided by:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT00603109

Purpose

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.

Condition	Intervention	Phase
Prader-Willi Syndrome	Drug: rimonabant Drug: placebo	Phase III

Genetics Home Reference related topics: Prader-Willi syndrome

MedlinePlus related topics: Prader-Willi Syndrome

Drug Information available for: Somatotropin Somatropin Rimonabant SR 141716A Ghrelin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Rimonabant, a Cannabinoid Receptor 1 Antagonist on Weight Gain and Body Composition in Adults With Prader Willi Syndrome.

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:

Body Weight and Body fat mass [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

IGF-1, Leptin, Ghrelin, Serum Lipids and insulin sensitivity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	18
Study Start Date:	August 2007
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Experimental Subjects receive rimonabant 20 mg per day PO	Drug: rimonabant rimonabant capsule 20 mg per day PO for 6 months
II: Placebo Comparator Subjects take placebo capsule one a day PO	Drug: placebo Subjects take 20 mg placebo capsule one a day PO for 6 months

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.
Subjects must be 18 to 35 years of age and fairly cooperative with the study protocol.
Subjects must have a BMI of at least 30 or more.

Exclusion Criteria:

Presence of pulmonary disease.
Presence of any other abnormal endocrine findings, including abnormal thyroid function.
Presence of significant behavioral problems or psychiatric illness including anxiety disorder and depression, interfering with the follow up of protocol. Any degree of depression and moderate to severe anxiety will be exclusion criteria for this study.
Subjects with Prader Willi Syndrome who are on other medications including growth hormone therapy, anti epileptic medications, or antipsychotic medications.
The presence of moderate to severe renal or liver disease. Mild elevations of liver enzymes are not exclusive.
Subjects who are on any other research or weight loss medication

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00603109

Contacts

Contact: Roja Motaghedi, MD	212-746-3462	rom9027@med.cornell.edu
Contact: Moris Angulo, MD	516-663-3090	MAngulo@Winthrop.org

Locations

United States, New York
New York Presbyterian Hospital-Weill Cornell Medical College	Recruiting
New york, New York, United States, 10065
Contact: Roja Motaghedi, MD 212-746-3462 rom9027@med.cornell.edu
Contact: Elizabeth G Diaz, CPNP 212-746-3462 egl2002@med.cornell.edu
Principal Investigator: Roja Motaghedi, MD
Sub-Investigator: Elizabeth G Diaz, CPNP

Sponsors and Collaborators

Weill Medical College of Cornell University

National Institutes of Health (NIH)

PWSAUSA

Investigators

Principal Investigator:	Roja Motaghedi, MD	NYPH-Weill Cornell Medical College
Principal Investigator:	Moris Angulo, MD	Winthrop University Hospital

More Information

Description of the study This link exits the ClinicalTrials.gov site

Responsible Party:	Weill Cornell Medical Center ( Roja Motaghedi, MD )
Study ID Numbers:	0611008841
Study First Received:	January 15, 2008
Last Updated:	January 26, 2008
ClinicalTrials.gov Identifier:	NCT00603109
Health Authority:	United States: Food and Drug Administration

Keywords provided by Weill Medical College of Cornell University:

Body weight, fat mass, growth hormone, ghrelin

Study placed in the following topic categories:

Chromosomal abnormalities
Obesity
Chromosome Disorders
Prader-Willi syndrome
Weight Gain
Body Weight
Mental Retardation
Signs and Symptoms
Genetic Diseases, Inborn

Body Weight Changes
Abnormalities, Multiple
Neurologic Manifestations
Nutrition Disorders
Overnutrition
Prader-Willi Syndrome
Congenital Abnormalities
Neurobehavioral Manifestations

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome
Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009