[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06961344":3,"trial-entities:NCT06961344":182,"trial-summary:NCT06961344":186},{"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":26,"interventions":29,"primary_outcomes":39,"secondary_outcomes":44,"sex":45,"minimum_age":46,"maximum_age":46,"healthy_volunteers":15,"eligibility_criteria":47,"std_ages":51,"locations":55,"central_contacts":178,"overall_officials":179,"references":180,"see_also_links":181},"NCT06961344","TIS6463-204","An Open-label Extension Safety Study of MELAS Patients Who Completed TIS6463-203 (PRIZM)","An Open-label Extension Study Evaluating the Safety of Zagociguat in Participants With MELAS Who Completed TIS6463-203","ACTIVE_NOT_RECRUITING","2028-07","2026-03","2026-07-07","2025-08-18","Tisento Therapeutics","INDUSTRY",false,"The goal of this clinical trial is to evaluate the long-term safety and tolerability of zagociguat in patients with MELAS who completed study medication treatment in the lead-in study TIS6463-203. TIS6463-204 is evaluating zagociguat in an open-label extension study at the daily dose of 15mg. The study medication is a once daily oral table and will be provided at the clinic and\u002For shipped to the participant's home. Study assessments will be conducted during clinic visits which will occur at three months and then at six months. Thereafter, clinic visits will occur every six months.","On Screening Visit Day -1 (which corresponds to Period 2 Week 12 Visit from lead-in study TIS6463-203), participants will sign the informed consent form, be confirmed eligible for this open-label extension study and undergo Screening Visit assessments. Eligible participants will begin dosing the next day on Day 1 (there is no Day 0) at home. Participants will have a 3-month visit and 6-month study visit at the clinic and thereafter will have a clinic visit every 6 months. Participants should have a Follow-up Visit 4 (+1) weeks after zagociguat discontinuation.",[19],"Mitochondrial Encephalopathy, Lactic Acidosis and Stroke-Like Episodes (MELAS Syndrome)",[21],"MELAS","INTERVENTIONAL","TREATMENT",[25],"PHASE2",{"count":27,"type":28},44,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":36},"DRUG","zagociguat 15mg","once daily oral tablets",[35],"Zagociguat 15mg",[37,38],"IW-6463","CY6463",[40],{"measure":41,"description":42,"timeFrame":43},"Incidence of Treatment-emergent Adverse Events (TEAEs)","TEAEs are any untoward event that may or may not be related to study medication.","Day 1 through the Follow-up for treatment period 4 weeks after last dose of study medication.",[],"ALL",null,{"inclusion":48,"exclusion":49,"raw_text":50},[],[],"Inclusion Criteria:\n\n1. Signed an Institutional Review Board (IRB)\u002FIndependent Ethics Committee (IEC)-approved informed consent form (ICF).\n2. Completed TIS6463-203 treatment through the Period 2 Week 12 Visit.\n3. Agrees to follow lifestyle restrictions.\n4. Other criteria per the protocol.\n\nExclusion Criteria:\n\n1\\. Any medical condition or clinical finding that, per investigator judgement, would preclude safe study participation and\u002For completion of all trial requirements.",[52,53,54],"CHILD","ADULT","OLDER_ADULT",[56,65,73,81,89,96,104,112,120,123,132,140,148,156,163,171],{"facility":57,"city":58,"state":59,"zip":60,"country":61,"geoPoint":62},"UC San Diego - Altman Clinical and Translational Research Institute","La Jolla","California","92037","United States",{"lat":63,"lon":64},32.84727,-117.2742,{"facility":66,"city":67,"state":68,"zip":69,"country":61,"geoPoint":70},"Children's Hospital of Colorado","Aurora","Colorado","80045",{"lat":71,"lon":72},39.72943,-104.83192,{"facility":74,"city":75,"state":76,"zip":77,"country":61,"geoPoint":78},"Rare Disease Research","Atlanta","Georgia","30329",{"lat":79,"lon":80},33.749,-84.38798,{"facility":82,"city":83,"state":84,"zip":85,"country":61,"geoPoint":86},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"lat":87,"lon":88},42.35843,-71.05977,{"facility":90,"city":91,"state":91,"zip":92,"country":61,"geoPoint":93},"Mount Sinai - Ichan School of Medicine","New York","10029",{"lat":94,"lon":95},40.71427,-74.00597,{"facility":97,"city":98,"state":99,"zip":100,"country":61,"geoPoint":101},"Akron Children's Hospital","Akron","Ohio","44308",{"lat":102,"lon":103},41.08144,-81.51901,{"facility":105,"city":106,"state":107,"zip":108,"country":61,"geoPoint":109},"Children's Hospital of Philadelphia","Philadelphia","Pennsylvania","19104",{"lat":110,"lon":111},39.95238,-75.16362,{"facility":113,"city":114,"state":115,"zip":116,"country":61,"geoPoint":117},"Baylor College of Medicine","Houston","Texas","77030",{"lat":118,"lon":119},29.76328,-95.36327,{"facility":121,"city":114,"state":115,"zip":116,"country":61,"geoPoint":122},"UT Health Houston",{"lat":118,"lon":119},{"facility":124,"city":125,"state":126,"zip":127,"country":128,"geoPoint":129},"Neuroscience Research Australia","Sydney","New South Wales","NSW 2031","Australia",{"lat":130,"lon":131},-33.86785,151.20732,{"facility":133,"city":134,"state":135,"zip":136,"country":128,"geoPoint":137},"Royal Melbourne Hospital","Melbourne","Victoria","3052",{"lat":138,"lon":139},-37.814,144.96332,{"facility":141,"city":142,"zip":143,"country":144,"geoPoint":145},"LMU Klinikum, Friedrich-Baur-Institute, Department of Neurology","Munich","80336","Germany",{"lat":146,"lon":147},48.13743,11.57549,{"facility":149,"city":150,"zip":151,"country":152,"geoPoint":153},"Neurologic Institute Carlo Besta of Milan","Milan","20133","Italy",{"lat":154,"lon":155},45.46427,9.18951,{"facility":157,"city":158,"zip":159,"country":152,"geoPoint":160},"Fondazione Policlinico Universitario Agostino Gemelli","Rome","00168",{"lat":161,"lon":162},41.89193,12.51133,{"facility":164,"city":165,"zip":166,"country":167,"geoPoint":168},"University College London Hospital. The National Hospital for Neurology and Neurosurgery, Centre for Neuromuscular Diseases","London","WC1N 3BG","United Kingdom",{"lat":169,"lon":170},51.50853,-0.12574,{"facility":172,"city":173,"zip":174,"country":167,"geoPoint":175},"The Newcastle upon Tyne NHS Foundation Trust","Newcastle upon Tyne","NE14LP",{"lat":176,"lon":177},54.97328,-1.61396,[],[],[],[],{"nct_id":4,"conditions":183,"biomarkers":185},[184],"MELAS Syndrome",[],{"nct_id":4,"found":15,"summary":46,"prompt_version":46}]