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

N/AEnrolling By InvitationNCT07450664

Soleno Therapeutics, Inc.200 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Prader-Willi Syndrome

Interventions

VYKAT XRDRUG

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

Sex: ALLMin age: 4 Years

Medical Language ↔ Plain English

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.

Locations (15)

Children's Hospital Los Angeles

Los Angeles, California, United States

Emory Children's Center

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

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.

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.

Data from ClinicalTrials.gov

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