[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Aeovian Pharmaceuticals, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":49},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100645336","phase-2-a-phase-2-study-of-the-safety-and-efficacy-of-av078-in-participants-with-tuberous-sclerosis-complex-tsc-refractory-epilepsy-100645336",false,"NCT07680322","A Phase 2 Study of the Safety and Efficacy of AV078 in Participants With Tuberous Sclerosis Complex (TSC) Refractory Epilepsy","A Parallel-Group, Phase 2, Double-Blind, Placebo-Controlled, Randomized Study of the Safety and Efficacy of Oral AV078 in Participants With Tuberous Sclerosis Complex (TSC) Refractory Epilepsy","RESTOR-1","Key Inclusion Criteria:\n\n* Participants aged 12 years and above.\n* Diagnosis of TSC based on International TSC Consensus Group criteria.\n* History of failure to adequately control seizures despite having been treated by two or more regimens of anti-seizure medications (ASMs).\n* Receiving a stable dose of ASMs for at least 4 weeks at the start of the Screening Period and for the duration of the study.\n\nKey Exclusion Criteria:\n\n* History of any infection requiring use of antibiotics within the last four weeks.\n* Current or history of any clinically significant mental or physical illness or condition other than TSC that the Investigator believes would create significant risk for participation in the study.\n* Recent epilepsy surgery\u002Fmajor surgery or planned surgery during the study.\n* Treatment with medicines which act in a similar way.\n* Treatment with medicines that suppress the immune system.\n* Treatment with medicines that may significantly affect the way the body handles the study drug.","ALL","12 Years",{"count":20,"type":21},42,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This Phase 2, randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, and efficacy of oral AV078 in participants with refractory epilepsy due to tuberous sclerosis complex (TSC). Approximately 42 participants will be randomized in a 5:1 ratio to receive AV078 or placebo.\n\nThe study will include a Screening Period collecting 4 weeks of pre-treatment Baseline data on seizure frequency, and progress to a 12-week Treatment Period, followed by an in person final follow-up visit approximately 2 weeks after the last dose.",[27,28],"Tuberous Sclerosis Complex","Epilepsy",[30,31,32,33,34,35,36],"Tuberous Sclerosis Complex (TSC)","Refractory Epilepsy","Drug-Resistant Epilepsy","Seizures","mTORC1 Inhibitor","AV078","mTOR Pathway","NOT_YET_RECRUITING","2026-06-25",{"date":40,"type":41},"2026-07-02","ACTUAL",{"date":43,"type":21},"2026-09-01",{"date":45,"type":21},"2027-12-21",{"name":47,"class":48},"Aeovian Pharmaceuticals, Inc.","INDUSTRY",""]