Observational Study of VYKAT™ XR in Patients With Prader-Willi Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VYKAT XR.
- Who it may be relevant to
- Registry conditions: Prader-Willi Syndrome. Basic parameters: from 4 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Observational Study of VYKAT™ XR (Diazoxide Choline Extended-Release Tablets) in Patients With Prader-Willi Syndrome (PWS)
Overview
Prospective observational study developed to generate more evidence of the safety profile, clinical characteristics and outcomes of patients with PWS treated with VYKAT XR.
Detailed description
Patients with PWS at participating sites who are initiating treatment or have initiated treatment with VYKAT XR, including patients who were previously treated with DCCR in a prior clinical study, will be invited to participate. Data from treatment prior to enrollment either from clinical practice or from previous DCCR clinical trials may be collected retrospectively.
Clinical care will not be mandated by the protocol.
Interventions
- Drug VYKAT XR
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.
Primary outcome measures
- Assess safety profile of patients with PWS treated with VYKAT XR. [Time frame: Adverse events for each patient will be collected from the time of first dose on VYKAT XR until the last contact with the patient.]
Eligibility criteria
Inclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 15 centers
- Children's Hospital Los Angeles — Los Angeles
- Emory Children's Center — Atlanta
- Northwestern University Feinberg School of Medicine — Chicago
- Indiana University — Indianapolis
- University of Michigan Medical Center — Ann Arbor
- Sparrow Clinical Research Institute — Lansing
- Children's Minnesota — Saint Paul
- Children's Mercy Hospital — Kansas City
- … and 7 more centers
Identifiers
NCT: NCT07450664 · C623