[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07450664":3,"trial-entities:NCT07450664":178,"trial-summary:NCT07450664":181},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":35,"secondary_outcomes":40,"sex":41,"minimum_age":42,"maximum_age":23,"healthy_volunteers":15,"eligibility_criteria":43,"std_ages":49,"locations":53,"central_contacts":174,"overall_officials":175,"references":176,"see_also_links":177},"NCT07450664","C623","Observational Study of VYKAT™ XR in Patients With Prader-Willi Syndrome","An Observational Study of VYKAT™ XR (Diazoxide Choline Extended-Release Tablets) in Patients With Prader-Willi Syndrome (PWS)","ENROLLING_BY_INVITATION","2028-03-02","2026-05","2026-05-19","2025-11-26","Soleno Therapeutics, Inc.","INDUSTRY",false,"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.\n\nClinical care will not be mandated by the protocol.",[19],"Prader-Willi Syndrome",[19,21],"PWS","OBSERVATIONAL",null,[],{"count":26,"type":27},200,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","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.",[34],"Patients with PWS who are currently receiving or initiating treatment with VYKAT XR.",[36],{"measure":37,"description":38,"timeFrame":39},"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.","Adverse events for each patient will be collected from the time of first dose on VYKAT XR until the last contact with the patient.",[],"ALL","4 Years",{"inclusion":44,"exclusion":47,"raw_text":48},[45,46],"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\u002For caregivers must provide written informed consent.",[],"Inclusion Criteria:\n\n* 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.\n* Patients and\u002For caregivers must provide written informed consent.",[50,51,52],"CHILD","ADULT","OLDER_ADULT",[54,63,71,79,87,95,102,110,118,126,134,142,150,158,166],{"facility":55,"city":56,"state":57,"zip":58,"country":59,"geoPoint":60},"Children's Hospital Los Angeles","Los Angeles","California","90027","United States",{"lat":61,"lon":62},34.05223,-118.24368,{"facility":64,"city":65,"state":66,"zip":67,"country":59,"geoPoint":68},"Emory Children's Center","Atlanta","Georgia","30322",{"lat":69,"lon":70},33.749,-84.38798,{"facility":72,"city":73,"state":74,"zip":75,"country":59,"geoPoint":76},"Northwestern University Feinberg School of Medicine","Chicago","Illinois","60611",{"lat":77,"lon":78},41.85003,-87.65005,{"facility":80,"city":81,"state":82,"zip":83,"country":59,"geoPoint":84},"Indiana University","Indianapolis","Indiana","46202",{"lat":85,"lon":86},39.76838,-86.15804,{"facility":88,"city":89,"state":90,"zip":91,"country":59,"geoPoint":92},"University of Michigan Medical Center","Ann Arbor","Michigan","48109",{"lat":93,"lon":94},42.27756,-83.74088,{"facility":96,"city":97,"state":90,"zip":98,"country":59,"geoPoint":99},"Sparrow Clinical Research Institute","Lansing","48912",{"lat":100,"lon":101},42.73253,-84.55553,{"facility":103,"city":104,"state":105,"zip":106,"country":59,"geoPoint":107},"Children's Minnesota","Saint Paul","Minnesota","55102",{"lat":108,"lon":109},44.94441,-93.09327,{"facility":111,"city":112,"state":113,"zip":114,"country":59,"geoPoint":115},"Children's Mercy Hospital","Kansas City","Missouri","64111",{"lat":116,"lon":117},39.09973,-94.57857,{"facility":119,"city":120,"state":121,"zip":122,"country":59,"geoPoint":123},"Saint Josephs Health","Paterson","New Jersey","07503",{"lat":124,"lon":125},40.91677,-74.17181,{"facility":127,"city":128,"state":129,"zip":130,"country":59,"geoPoint":131},"Long Island Jewish Valley Stream","Valley Stream","New York","11580",{"lat":132,"lon":133},40.66427,-73.70846,{"facility":135,"city":136,"state":137,"zip":138,"country":59,"geoPoint":139},"UNC Hospitals","Chapel Hill","North Carolina","27514",{"lat":140,"lon":141},35.9132,-79.05584,{"facility":143,"city":144,"state":145,"zip":146,"country":59,"geoPoint":147},"Legacy Emanuel Medical Center","Portland","Oregon","97227",{"lat":148,"lon":149},45.52345,-122.67621,{"facility":151,"city":152,"state":153,"zip":154,"country":59,"geoPoint":155},"Vanderbilt University Medical Center","Nashville","Tennessee","37232",{"lat":156,"lon":157},36.16589,-86.78444,{"facility":159,"city":160,"state":161,"zip":162,"country":59,"geoPoint":163},"Children's Medical Center Dallas","Dallas","Texas","75231",{"lat":164,"lon":165},32.78306,-96.80667,{"facility":167,"city":168,"state":169,"zip":170,"country":59,"geoPoint":171},"Seattle Children's Hospital","Seattle","Washington","98105",{"lat":172,"lon":173},47.60621,-122.33207,[],[],[],[],{"nct_id":4,"conditions":179,"biomarkers":180},[19],[],{"nct_id":4,"found":15,"summary":23,"prompt_version":23}]