A Study of Diazoxide Choline in Patients With Prader-Willi Syndrome

Completed · Phase 3 · Has a placebo group

Conditions studied: Prader-Willi Syndrome

In brief

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.

Key facts

Study ID

NCT03440814

Run by

Soleno Therapeutics, Inc.

People needed

127

Starts

2018-05-09

Expected to finish

2020-05-01

Last updated by the study team

2023-09-21

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 (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

You may not qualify if…

• 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

Where it is running

• University of California, Irvine — Orange, California, United States
• Stanford University — Palo Alto, California, United States
• Rady Children's Hospital San Diego — San Diego, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• University of Florida Gainesville — Gainesville, Florida, United States
• Emory Children's Center — Atlanta, Georgia, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• National Institutes of Health Hatfield Clinical Research Center — Bethesda, Maryland, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Sparrow Clinical Research Institute — Lansing, Michigan, United States
• Children's 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
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, 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 Hospital — Seattle, Washington, United States
• The Queen Elizabeth University — Glasgow, Scottland, United Kingdom
• Hull and East Yorkshire Hospitals NHS Trust — Hull, Yorkshire, United Kingdom
• Birmingham Women's and Children's Hospital — Birmingham, United Kingdom
• Fulbourn Hospital — Cambridge, United Kingdom
• Alder Hey Children's Hospital NHS Foundation Trust — Liverpool, United Kingdom

Full record on ClinicalTrials.gov

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