The purpose of this is study is to evaluate the long-term safety of DCCR (diazoxide choline) extended-release tablets) in patients with Prader-Willi syndrome.
Eligibility
Sex
ALL
Min age
4 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Provide voluntary, written informed consent (parent(s) / legal guardian(s) of patient); provide voluntary, written assent (subjects, as appropriate)
2. Participant must:
1. Have participated in and completed the Study C602 Randomized Withdrawal (RW) Period;
2. Have participated in but discontinued from the Study C602 RW Period and at least 16 weeks have elapsed since the date of their randomization into the C602 RW Period; or
3. Have participated in Study C602 OLE period, did not consent to participate in the RW Period, and at least 16 weeks have elapsed since the date of their C602 Open-Label Extension End of Treatment Visit.
Exclusion Criteria:
1. Positive urine pregnancy test (in females of child-bearing potential)
2. Females who are pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed during or within 30 days after study participation.
3. Participation in a clinical study of an investigational drug (including approved drugs for unapproved uses), investigational device, or therapeutic intervention subsequent to the C602 Open-Label Extension End of Treatment Visit.
Primary outcome measure(s)
Safety of DCCR (adverse events. Safety analyses will be conducted in all subjects who receive at least one dose of DCCR in the C614 study. ( Adverse events) — Baseline to End of Study or until resolution of certain adverse events Assess the safety of DCCR by evaluating the incidence and severity of adverse events.
Safety analyses will be conducted in all subjects who receive at least one dose of DCCR in the C614 study. Adverse events will be described by type and level of severity.
Trial sites (22)
Facility
City
Region
Status
UC Irvine
Orange
California
Stanford University
Palo Alto
California
Rady Children's Hospital of San Diego
San Diego
California
U of Florida Gainesville
Gainesville
Florida
Emory Children's Center
Atlanta
Georgia
Indiana University School of Medicine
Indianapolis
Indiana
National Institutes of Health
Bethesda
Maryland
Boston Children's Hospital
Boston
Massachusetts
Sparrow Clinical Research Institute
Lansing
Michigan
Children's Hospital and Clinic Minnesota
Saint Paul
Minnesota
St. Joseph's University Medical Center
Paterson
New Jersey
NYU Winthrop Hospital
Mineola
New York
The Research Institute at Nationwide Children's Hospital
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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