Observational Study of VYKAT™ XR in Patients With Prader-Willi Syndrome
An Observational Study of VYKAT™ XR (Diazoxide Choline Extended-Release Tablets) in Patients With Prader-Willi Syndrome (PWS)
1 other identifier
observational
200
1 country
15
Brief Summary
Prospective observational study developed to generate more evidence of the safety profile, clinical characteristics and outcomes of patients with PWS treated with VYKAT XR.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2025
Typical duration for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 26, 2025
CompletedFirst Submitted
Initial submission to the registry
February 9, 2026
CompletedFirst Posted
Study publicly available on registry
March 5, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 2, 2028
May 19, 2026
May 1, 2026
2.3 years
February 9, 2026
May 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assess safety profile of patients with PWS treated with VYKAT XR.
The safety profile will be based on adverse events, including nonserious adverse events, serious adverse events, and adverse events leading to discontinuation of VYKAT XR.
Adverse events for each patient will be collected from the time of first dose on VYKAT XR until the last contact with the patient.
Study Arms (1)
Patients with PWS who are currently receiving or initiating treatment with VYKAT XR.
All patients with PWS at participating sites who are initiating treatment or have initiated treatment with VYKAT XR at the time of enrollment into this observational study, including patients who were previously treated with DCCR in a prior clinical study, will be invited to participate. Although the overall observational study is prospective, data from treatment prior to enrollment into the observational study, either from clinical practice or from DCCR clinical trials, may be collected retrospectively.
Interventions
All prospective treatment in this protocol will be commercial VYKAT XR prescribed to patients by their physicians in addition to their standard of care; patients will not receive experimental intervention or treatment from the Sponsor as part of their participation in this study.
Eligibility Criteria
This study will enroll patients with PWS who are currently receiving or initiating treatment with VYKAT XR.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Emory Children's Center
Atlanta, Georgia, 30322, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611, United States
Indiana University
Indianapolis, Indiana, 46202, United States
University of Michigan Medical Center
Ann Arbor, Michigan, 48109, United States
Sparrow Clinical Research Institute
Lansing, Michigan, 48912, United States
Children's Minnesota
Saint Paul, Minnesota, 55102, United States
Children's Mercy Hospital
Kansas City, Missouri, 64111, United States
Saint Josephs Health
Paterson, New Jersey, 07503, United States
Long Island Jewish Valley Stream
Valley Stream, New York, 11580, United States
UNC Hospitals
Chapel Hill, North Carolina, 27514, United States
Legacy Emanuel Medical Center
Portland, Oregon, 97227, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Children's Medical Center Dallas
Dallas, Texas, 75231, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2026
First Posted
March 5, 2026
Study Start
November 26, 2025
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
March 2, 2028
Last Updated
May 19, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share