Clinical Trials in the USA / NCT07450664
Enrolling by invitation
Observational
Observational Study of VYKAT™ XR in Patients With Prader-Willi Syndrome
NCT07450664 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Prader-Willi Syndrome
Investigational drug(s) / intervention(s)
VYKAT XR
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
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.
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 (25)
| Facility | City | Region | Status |
|---|---|---|---|
| Soleno Clinical Site | Phoenix | Arizona | |
| Soleno Clinical Site | Los Angeles | California | |
| Soleno Clinical Site | Sacramento | California | |
| Soleno Clinical Site | Aurora | Colorado | |
| Soleno Clinical Site | Gainesville | Florida | |
| Soleno Clinical Site | Atlanta | Georgia | |
| Soleno Clinical Site | Chicago | Illinois | |
| Soleno Clinical Site | Indianapolis | Indiana | |
| Soleno Clinical Site | Boston | Massachusetts | |
| Soleno Clinical Site | Ann Arbor | Michigan | |
| Soleno Clinical Site | Lansing | Michigan | |
| Soleno Clinical Site | Minneapolis | Minnesota | |
| Soleno Clinical Site | Rochester | Minnesota | |
| Soleno Clinical Site | Saint Paul | Minnesota | |
| Soleno Clinical Site | Kansas City | Missouri | |
| Soleno Clinical Site | Paterson | New Jersey | |
| Soleno Clinical Site | Valley Stream | New York | |
| Soleno Clinical Site | Chapel Hill | North Carolina | |
| Soleno Clinical Site | Durham | North Carolina | |
| Soleno Clinical Site | Portland | Oregon | |
| Soleno Clinical Site | Nashville | Tennessee | |
| Soleno Clinical Site | Dallas | Texas | |
| Soleno Clinical Site | Houston | Texas | |
| Soleno Clinical Site | Salt Lake City | Utah | |
| Soleno Clinical Site | Seattle | Washington |
Other trials for the same condition
A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment
Active, not recruiting
A Study of Pitolisant in Participants With Prader-Willi Syndrome
Enrolling by invitation
A Study of Setmelanotide in Patients With Prader-Willi Syndrome
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07450664 on ClinicalTrials.gov ↗ ← All trials in the USA