Prader-willi Syndrome Clinical Trial
Official title:
Effect of Rimonabant, a Cannabinoid Receptor 1 Antagonist on Weight Gain and Body Composition in Adults With Prader Willi Syndrome.
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05032326 -
Long-term Interventional Follow-up Study of Children With Prader-Willi Syndrome Included in the OTBB3 Clinical Trial
|
Phase 3 | |
| Completed |
NCT04526379 -
Study of Emotion and Cognition Abilities of Children With PWS and Proposition of an Innovative Remediation
|
N/A | |
| Terminated |
NCT03458416 -
A Study to Assess the Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Participants With Prader-Willi Syndrome
|
Phase 2 | |
| Completed |
NCT03718416 -
Natural History Study of Serious Medical Events in PWS
|
||
| Active, not recruiting |
NCT05322096 -
Study to Evaluate Efficacy, Safety, and Tolerability of RGH-706 in Prader-Willi Syndrome
|
Phase 2 | |
| Completed |
NCT02205450 -
Growth Hormone in Children Under 2 Years With Prader-Willi in Hospital of Sabadell
|
||
| Terminated |
NCT02179151 -
Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Beloranib) in Obese Subjects With Prader-Willi Syndrome
|
Phase 3 | |
| Completed |
NCT00375089 -
Characteristics of Prader-Willi Syndrome and Early-onset Morbid Obesity
|
N/A | |
| Completed |
NCT00004351 -
Study of Phenotype and Genotype Correlations in Patients With Contiguous Gene Deletion Syndromes
|
N/A | |
| Recruiting |
NCT05879614 -
An Open-Label Study of Oral NNZ-2591 in Prader-Willi Syndrome (PWS-001)
|
Phase 2 | |
| Recruiting |
NCT05938543 -
Cerebellar TMS and Satiety in Prader-Willi Syndrome
|
N/A | |
| Recruiting |
NCT03031626 -
Oxygen Versus Medical Air for Treatment of CSA in Prader Will Syndrome
|
Phase 4 | |
| Withdrawn |
NCT04086810 -
An Open-Label Study of DCCR Tablet in Patients With PWS
|
Phase 3 | |
| Completed |
NCT02629991 -
Oxytocin vs. Placebo for the Treatment Hyperphagia in Children and Adolescents With Prader-Willi Syndrome
|
Phase 2 | |
| Recruiting |
NCT02297022 -
Deep Brain Stimulation for the Treatment of Obesity in Patients With Prader-Willi Syndrome
|
Phase 1 | |
| Not yet recruiting |
NCT02263781 -
PREPL in Health and Disease
|
N/A | |
| Completed |
NCT00551343 -
Gut Derived Hormones, Body Composition and Metabolism in Prader-Willi Syndrome
|
N/A | |
| Enrolling by invitation |
NCT03655223 -
Early Check: Expanded Screening in Newborns
|
||
| Recruiting |
NCT05939453 -
Impact of Bright Light Therapy on Prader-Willi Syndrome
|
N/A | |
| Recruiting |
NCT04463316 -
GROWing Up With Rare GENEtic Syndromes
|