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ACTIVE NOT RECRUITING
NCT05701774
PHASE3

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

Sponsor: Soleno Therapeutics, Inc.

View on ClinicalTrials.gov

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.

Official title: An Open-Label Study of DCCR (Diazoxide Choline) Extended-Release Tablets in Patients With Prader-Willi Syndrome

Key Details

Gender

All

Age Range

4 Years - Any

Study Type

INTERVENTIONAL

Enrollment

83

Start Date

2023-01-31

Completion Date

2028-06

Last Updated

2025-04-02

Healthy Volunteers

No

Interventions

DRUG

DCCR

Once daily oral administration

Locations (22)

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

Sparrow Clinical Research Institute

Lansing, Michigan, 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

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