Observational Study of VYKAT™ XR in Patients With Prader-Willi Syndrome

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Assess safety profile of patients with PWS treated with 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.
  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.

Trial sites (24)

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