WUH: A randomized double-blind placebo-controlled study of diazoxide choline controlled-relealese tablet (DCCR) in patients with prader-Willi Syndrome.

Brief description of study

The purpose of this research is to evaluate if diazoxide choline controlled-release (DCCR) tablet has an effect on hyperphagia (increased appetite) and other aspects of Prader-Willi syndrome (PWS) in PWS patients. DCCR contains diazoxide, which has been approved in the US as a treatment for babies, children, and adults with low levels of sugar in their blood. The researchers developed DCCR, to allow a slow release in the body. The researchers want to find out if DCCR has a positive effect in reducing PWS patients' appetite, amount of body fat, aggressive and destructive behaviors, and improving other aspects related to PWS. DCCR has not been approved by the FDA as a treatment for any of these conditions. The study treatments evaluated in this study, DCCR or placebo, and some of the evaluations that may be used to evaluate DCCR or placebo and are not part of your standard of care, are experimental.

Clinical Study Identifier: s18-01439
ClinicalTrials.gov Identifier: NCT02034071
Principal Investigator: Jorge Mejia-Corletto.

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