Observational Study of VYKAT™ XR in Patients With Prader-Willi Syndrome
Enrolling by invitation
Conditions studied: Prader-Willi Syndrome
In brief
Prospective observational study developed to generate more evidence of the safety profile, clinical characteristics and outcomes of patients with PWS treated with VYKAT XR.
Key facts
- Study ID
- NCT07450664
- Run by
- Soleno Therapeutics, Inc.
- People needed
- 200
- Starts
- 2025-11-26
- Expected to finish
- 2028-03-02
- Last updated by the study team
- 2026-05-19
Who can join
Age: 4 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients currently receiving or initiating treatment with VYKAT XR, including patients who previously received DCCR or are transitioning from DCCR to VYKAT XR in the context of a prior DCCR clinical trial.
- Patients and/or caregivers must provide written informed consent.
Where it is running
- Children's Hospital Los Angeles — Los Angeles, California, United States
- Emory Children's Center — Atlanta, Georgia, United States
- Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
- Indiana University — Indianapolis, Indiana, United States
- University of Michigan Medical Center — Ann Arbor, Michigan, United States
- Sparrow Clinical Research Institute — Lansing, Michigan, United States
- Children's Minnesota — Saint Paul, Minnesota, United States
- Children's Mercy Hospital — Kansas City, Missouri, United States
- Saint Josephs Health — Paterson, New Jersey, United States
- Long Island Jewish Valley Stream — Valley Stream, New York, United States
- UNC Hospitals — Chapel Hill, North Carolina, United States
- Legacy Emanuel Medical Center — Portland, Oregon, United States
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
- Children's Medical Center Dallas — Dallas, Texas, United States
- Seattle Children's Hospital — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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