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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Weill Medical College of Cornell University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
PWSAUSA
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00603109
First received: January 15, 2008
Last updated: January 3, 2011
Last verified: January 2011
  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 3

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

Resource links provided by NLM:


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
Experimental: I
Subjects receive rimonabant 20 mg per day PO
Drug: rimonabant
rimonabant capsule 20 mg per day PO for 6 months
Other Name: Acomplia
Placebo Comparator: II
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:

  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.
  3. 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.
  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Roja Motaghedi, MD, Weill Cornell Medical Center
ClinicalTrials.gov Identifier: NCT00603109     History of Changes
Other Study ID Numbers: 0611008841
Study First Received: January 15, 2008
Last Updated: January 3, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Weill Medical College of Cornell University:
Body weight, fat mass, growth hormone, ghrelin

Additional relevant MeSH terms:
Prader-Willi Syndrome
Weight Gain
Mental Retardation
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Obesity
Overnutrition
Nutrition Disorders
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014