Open-Label Extension Study of DCCR in Patients With Prader-Willi Syndrome
- Conditions
- Prader-Willi Syndrome
- Interventions
- Drug: DCCR
- Registration Number
- NCT05701774
- Lead Sponsor
- Soleno Therapeutics, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 83
-
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DCCR DCCR 75 - 525 mg DCCR
- Primary Outcome Measures
Name Time Method 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 Week 262 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (22)
Boston Children's Hospital
πΊπΈBoston, Massachusetts, United States
The Queen Elizabeth University
π¬π§Glasgow, United Kingdom
Children's Hospital and Clinic Minnesota
πΊπΈSaint Paul, Minnesota, United States
Fulbourn Hospital
π¬π§Cambridge, United Kingdom
UC Irvine
πΊπΈOrange, California, United States
St. Joseph's University Medical Center
πΊπΈPaterson, New Jersey, United States
Royal London Hospital
π¬π§London, United Kingdom
Chelsea and Westminster Hospital
π¬π§London, United Kingdom
Indiana University School of Medicine
πΊπΈIndianapolis, Indiana, United States
Vanderbilt University
πΊπΈNashville, Tennessee, United States
NYU Winthrop Hospital
πΊπΈMineola, New York, United States
Stanford University
πΊπΈPalo Alto, California, United States
Emory Children's Center
πΊπΈAtlanta, Georgia, United States
Rady Children's Hospital of San Diego
πΊπΈSan Diego, California, United States
Research Institute of Dallas
πΊπΈDallas, Texas, United States
University of Utah
πΊπΈSalt Lake City, Utah, United States
Hull and East Yorkshire Hospitals NHS Trust
π¬π§Hull, United Kingdom
Seattle Children's
πΊπΈSeattle, Washington, United States
The Research Institute at Nationwide Children's Hospital
πΊπΈColumbus, Ohio, United States
Sparrow Clinical Research Institute
πΊπΈLansing, Michigan, United States
U of Florida Gainesville
πΊπΈGainesville, Florida, United States
National Institutes of Health
πΊπΈBethesda, Maryland, United States
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