A Study of Diazoxide Choline in Patients With Prader-Willi Syndrome
Trial ID or NCT#
NCT03440814
Status
RECRUITING
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
Eligibility Criteria
Ages Eligible for Study: Older than 4 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Investigator(s)
David Stevenson
Diane Stafford
Contact us to find out if this trial is right for you.
Contact
Alicia Harnett
650-723-0441
View on ClinicalTrials.gov
