[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645336":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":31,"locations":25,"responsibleParty":37,"collaborators":25,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":41,"sex":47,"minAge":48,"maxAge":25,"enrollmentInfo":49,"targetDuration":25,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":66,"whyStopped":25,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":25},{"fullName":5,"class":6},"Aeovian Pharmaceuticals, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"AV078","EXPERIMENTAL","Participants will receive oral AV078 once daily in addition to their stable background anti-seizure medication regimen for 12 weeks. Dosing will be titrated based on measured drug concentrations to achieve target exposure levels.",[13],"Drug: AV078",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants will receive matching oral placebo once daily in addition to their stable background anti-seizure medication regimen for 12 weeks. Dose adjustments may be performed in a manner similar to active treatment to maintain blinding.",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","AV078 is a selective inhibitor of mammalian target of rapamycin complex 1 (mTORC1) administered orally once daily. Dosing may be adjusted based on measured drug concentrations to achieve target exposure levels.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":29},"Matching oral placebo administered once daily. The placebo is formulated to match AV078 and may undergo dose adjustments similar to active treatment to maintain blinding.",[15],[30],"Matching Placebo",[32],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},"Davis Ryman, MD, PhD","CONTACT","510-961-1148","info@aeovian.com",{"type":38,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","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":50,"type":51},42,"ESTIMATED","INTERVENTIONAL",[54],"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.",[57,58],"Tuberous Sclerosis Complex","Epilepsy",[60,61,62,63,64,9,65],"Tuberous Sclerosis Complex (TSC)","Refractory Epilepsy","Drug-Resistant Epilepsy","Seizures","mTORC1 Inhibitor","mTOR Pathway","NOT_YET_RECRUITING","2026-06-25",{"date":69,"type":70},"2026-07-02","ACTUAL",{"date":72,"type":51},"2026-09-01",{"date":74,"type":51},"2027-12-21",{"name":5,"class":6}]