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A Study of Diazoxide Choline in Patients With Prader-Willi Syndrome
Not Recruiting
Trial ID: NCT03440814
Purpose
The purpose of this is study is to evaluate the effects of DCCR (diazoxide choline controlled release tablets) in children and adults with Prader-Willi syndrome.
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients With Prader-Willi Syndrome
Stanford Investigator(s)
Eligibility
Inclusion Criteria:
* Provide voluntary, written informed consent (parent(s) / legal guardian(s) of patient); provide voluntary, written assent (patients, as appropriate)
* Genetically-confirmed Prader-Willi syndrome and hyperphagic
* In a stable care setting for at least 6 months prior to Visit 1
* Caregiver must have been caring for the patient for at least 6 months prior to Visit 1
Exclusion Criteria:
* Have participated in an interventional clinical study (i.e., investigational drug or device, approved drugs or device evaluated for unapproved use) within prior 3 months
* Positive urine pregnancy test (in females of child-bearing potential) or females who are pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed during or within 30 days after study participation
* Any other known disease and/or condition, which would prevent, in the opinion of the Investigator, the patient from completing all study visits and assessments required by the protocol
Intervention(s):
drug: DCCR
drug: Placebo for DCCR
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Alicia Harnett
650-723-0441