Open-Label Extension Study of DCCR in Patients With Prader-Willi Syndrome

Running, not enrolling · Phase 3

Conditions studied: Prader-Willi Syndrome

In brief

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.

Key facts

Study ID

NCT05701774

Run by

Soleno Therapeutics, Inc.

People needed

83

Starts

2023-01-31

Expected to finish

2028-06-01

Last updated by the study team

2025-04-02

Who can join

Age: 4 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• UC Irvine — Orange, California, United States
• Stanford University — Palo Alto, California, United States
• Rady Children's Hospital of San Diego — San Diego, California, United States
• U of Florida Gainesville — Gainesville, Florida, United States
• Emory Children's Center — Atlanta, Georgia, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• National Institutes of Health — Bethesda, Maryland, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Children's Hospital and Clinic Minnesota — Saint Paul, Minnesota, United States
• St. Joseph's University Medical Center — Paterson, New Jersey, United States
• NYU Winthrop Hospital — Mineola, New York, United States
• The Research Institute at Nationwide Children's Hospital — Columbus, Ohio, United States
• Vanderbilt University — Nashville, Tennessee, United States
• Research Institute of Dallas — Dallas, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• Seattle Children's — Seattle, Washington, United States
• Fulbourn Hospital — Cambridge, United Kingdom
• Sparrow Clinical Research Institute — Lansing, Michigan, United States
• The Queen Elizabeth University — Glasgow, United Kingdom
• Hull and East Yorkshire Hospitals NHS Trust — Hull, United Kingdom
• Royal London Hospital — London, United Kingdom
• Chelsea and Westminster Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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