Open-Label Extension Study of DCCR in PWS Followed by Double-Blind, Placebo-Controlled, Randomized Withdrawal Period
Completed · Phase 3 · Has a placebo group
Conditions studied: Prader-Willi Syndrome
In brief
This is a multi-center, multi-period study with an open-label period followed by a double-blind, placebo-controlled, randomized withdrawal period evaluating the safety and efficacy of DCCR treatment.
Key facts
- Study ID
- NCT03714373
- Run by
- Soleno Therapeutics, Inc.
- People needed
- 115
- Starts
- 2018-10-01
- Expected to finish
- 2023-08-17
- Last updated by the study team
- 2024-04-19
Who can join
Age: 4 and older. Sex: any. Healthy volunteers: not accepted.
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
- Aintree University Hospital NHS Foundation Trust — Liverpool, United Kingdom
Full record on ClinicalTrials.gov
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