Open-Label Extension Study of DCCR in Patients With Prader-Willi Syndrome
An Open-Label Study of DCCR (Diazoxide Choline) Extended-Release Tablets in Patients With Prader-Willi Syndrome
1 other identifier
interventional
83
2 countries
22
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2023
Longer than P75 for phase_3
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2023
CompletedFirst Posted
Study publicly available on registry
January 27, 2023
CompletedStudy Start
First participant enrolled
January 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
April 2, 2025
March 1, 2025
5.3 years
January 18, 2023
March 28, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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)
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.
Baseline to End of Study or until resolution of certain adverse events
Study Arms (1)
DCCR
EXPERIMENTAL75 - 525 mg DCCR
Interventions
Eligibility Criteria
You may qualify if:
- Provide voluntary, written informed consent (parent(s) / legal guardian(s) of patient); provide voluntary, written assent (subjects, as appropriate)
- Participant must:
- Have participated in and completed the Study C602 Randomized Withdrawal (RW) Period;
- 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
- 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.
You may not qualify if:
- Positive urine pregnancy test (in females of child-bearing potential)
- Females who are pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed during or within 30 days after study participation.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
UC Irvine
Orange, California, 92868, United States
Stanford University
Palo Alto, California, 94304, United States
Rady Children's Hospital of San Diego
San Diego, California, 92123, United States
U of Florida Gainesville
Gainesville, Florida, 32608, United States
Emory Children's Center
Atlanta, Georgia, 30329, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
National Institutes of Health
Bethesda, Maryland, 20892, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Sparrow Clinical Research Institute
Lansing, Michigan, 48912, United States
Children's Hospital and Clinic Minnesota
Saint Paul, Minnesota, 55102, United States
St. Joseph's University Medical Center
Paterson, New Jersey, 07503, United States
NYU Winthrop Hospital
Mineola, New York, 11501, United States
The Research Institute at Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Vanderbilt University
Nashville, Tennessee, 37212, United States
Research Institute of Dallas
Dallas, Texas, 75231, United States
University of Utah
Salt Lake City, Utah, 84112, United States
Seattle Children's
Seattle, Washington, 98105, United States
Fulbourn Hospital
Cambridge, CB21 5EF, United Kingdom
The Queen Elizabeth University
Glasgow, G51 4TF, United Kingdom
Hull and East Yorkshire Hospitals NHS Trust
Hull, HU3 2JZ, United Kingdom
Royal London Hospital
London, E1 1BB, United Kingdom
Chelsea and Westminster Hospital
London, SW10 9NH, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2023
First Posted
January 27, 2023
Study Start
January 31, 2023
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2028
Last Updated
April 2, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share