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A Study of Diazoxide Choline in Patients With Prader-Willi Syndrome
Recruiting
I'm InterestedTrial 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
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Alicia Harnett
650-723-0441