Prader-Willi Syndrome
Conditions
Keywords
Prader-Willi Syndrome, PWS
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.
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
DRUGVYKAT 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.
Sponsors
Soleno Therapeutics, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed