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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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27 March 2023 |
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Main ID: |
NCT00603109 |
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Date of registration:
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15/01/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Rimonabant on Weight Gain and Body Composition in Adults With Prader Willi Syndrome
PWS |
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Scientific title:
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Effect of Rimonabant, a Cannabinoid Receptor 1 Antagonist on Weight Gain and Body Composition in Adults With Prader Willi Syndrome. |
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Date of first enrolment:
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August 2007 |
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Target sample size:
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10 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT00603109 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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United States
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Contacts
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Name:
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Moris Angulo, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Winthrop University Hospital |
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Name:
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Roja Motaghedi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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NYPH-Weill Cornell Medical College |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
35 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Prader-willi Syndrome
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Intervention(s)
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Drug: placebo
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Drug: rimonabant
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Primary Outcome(s)
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Body Weight and Body fat mass
[Time Frame: 6 months]
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Secondary Outcome(s)
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IGF-1, Leptin, Ghrelin, Serum Lipids and insulin sensitivity
[Time Frame: 6 months]
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Secondary ID(s)
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0611008841
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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