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A Study Of VYKATTM XR (Diazoxide Choline Extended-Release Tablets) For Hyperphagia In 4 Years Of Age And Older With Prader-Willi Syndrome (PWS)

Overview

About this study

The purpose of this study is to gain a better understanding of the safety profile, clinical characteristics, and outcomes in patients with Prader-Willi syndrome (PWS) treated with VYKAT XR in a real-world setting.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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. This would include patients who completed their clinical trial participation or who withdrew from a DCCR clinical trial prior to the initiation of the observational study.

  • Patients and/or caregivers must provide written informed consent.

Exclusion Criteria:

  • None

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 12/22/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kalpana Muthusamy, M.D.

Contact us for the latest status

Contact information:

Emily Oldham

oldham.emmett@mayo.edu

More information

Publications

Publications are currently not available

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CLS-20599556

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