[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"focal-cortical-dysplasia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:focal-cortical-dysplasia":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100615023","phase-1-safety-tolerability-and-pharmacokinetics-of-svg103-paxalisib-in-focal-cortical-dysplasia-type-ii-fcd-ii-tuberous-sclerosis-complex-tsc-or-hemimegalencephaly-hme-100615023",false,"NCT07287202","Safety, Tolerability, and Pharmacokinetics of SVG103 (Paxalisib) in Focal Cortical Dysplasia Type II (FCD-II), Tuberous Sclerosis Complex (TSC) or Hemimegalencephaly (HME)","An Open-Label Phase 1b\u002F2a Study to Evaluate the Safety and Tolerability of Oral SVG103 (Paxalisib) in Adults With Focal Cortical Dysplasia Type II (FCD-II), Tuberous Sclerosis Complex (TSC) or Hemimegalencephaly (HME), Followed by Long-Term Treatment","Key Inclusion Criteria:\n\n1. Participants diagnosed with:\n\n   * FCD-II: diagnosis of FCD Type II based on clinical symptoms and confirmed by a positive magnetic resonance imaging (MRI) or histological\u002Fpathological analysis of brain tissue, or\n   * TSC: diagnosis of TSC by either clinical or genetic diagnostic criteria as documented in the participant's medical record, or\n   * HME: Definitive HME confirmed with MRI.\n2. Male or female between the ages of 18 and 65 years of age (inclusive).\n3. History of failure to control seizures despite at least 2 ASMs at appropriate dosages and duration of treatment.\n4. Participants must have experienced at least 8 countable seizures per month for 2 of the 3 months as documented in historical seizure diaries before the baseline period.\n\n6\\. If participants are on a ketogenic or modified atkins diet, that the regimen can remain unchanged throughout the study, in the opinion of the investigator.\n\n7\\. Participants with Neurostimulation devices (i.e. Vagus Nerve Stimulation (VNS), Responsive Neuro Stimulation (RNS), Deep Brain Stimulation (DBS) who meet all of the following conditions:\n\n* The device has been implanted for ≥1 year prior to the screening visit.\n* The settings must have remained constant for 3 months prior to the screening visit and can remain constant throughout the study, in the opinion of the investigator.\n* The battery is expected to last throughout the study. 8. A participant\u002Fcaregiver or LAR willing to give written informed consent, after being properly informed of the nature and risks of the study and prior to engaging in any study-related procedures.\n\nKey Exclusion Criteria:\n\n1. Clinically significant hepatic, renal, pulmonary, gastrointestinal, neurological (other than epilepsy; HME; TSC; FCD-II), autoimmune, immunological, infections, hematological, malignant conditions that may interfere with or impact the participation in the study or study conduct, as determined but the investigator or sponsor.\n2. Immunocompromised participants, defined as acquired immune deficiency syndrome (AIDS), cancer, malnutrition, and certain genetic disorders or undergoing treatment with anticancer drugs, radiation therapy, and stem cell or organ transplant.\n3. Participants who have an active central nervous system (CNS) infection, demyelinating disease, degenerative neurological disease, or CNS disease deemed progressive as evaluated by brain imaging (magnetic resonance imaging \\[MRI\\]).\n4. Participants being considered for brain surgery during the study or has undergone brain surgery within 6 months prior to screening visit for epilepsy or any other reason.\n5. Participants with HbA1c levels ≥9.0%, or with hyperglycemia or diabetes requiring insulin therapy, or significant uncontrolled hyperglycaemia or diabetes mellitus that would compromise patient safety, as determined by the investigator.\n6. Participants with active pneumonitis that are clinically symptomatic.\n7. Participants with a history of myocardial infarction or coronary artery disease or clinically significant ECG abnormality.\n8. Participants who have clinically significant hepatic, renal and blood laboratory values at baseline period.\n9. Participants with known sensitivity or allergy to any component in the investigational product(s) (microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and colloidal silicon dioxide).","ALL","18 Years","65 Years",{"count":20,"type":21},15,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is a multinational, open-label, single-arm trial of adjunctive SVG103 (paxalisib) treatment in adults with FCD-II, TSC, and HME.",[28,29,30],"Focal Cortical Dysplasia","Tuberous Sclerosis Complex (TSC)","Hemimegalencephaly",[32,33,34],"FCD-II","TSC","HME","NOT_YET_RECRUITING","2025-12-22",{"date":38,"type":39},"2025-12-23","ACTUAL",{"date":41,"type":21},"2026-03",{"date":43,"type":21},"2027-06",{"name":45,"class":46},"Sovargen","INDUSTRY",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100520215","mos-fed-mosaicism-in-focal-epilepsy-cortical-dysplasia-tissue-100520215","NCT06053671","Mos-FED (Mosaicism in Focal Epilepsy Cortical Dysplasia Tissue)","Dissecting mTOR Pathway Mosaicism in FCDII-Harbouring Epileptic Brain and Peripheral Tissue.","MosFED","Epilepsy in Focal Cortical Dysplasia Type IIA\u002FB\n\nKey Inclusion Criteria:\n\n1. Adult and Paediatric Patients (male and female)\n2. A histologically proven diagnosis of FCDIIA\u002FB or a suspected diagnosis of FCDIIA\u002FB (on MRI\u002FEEG and PET grounds) awaiting resective Epilepsy surgery.\n3. Able to attend appointment\u002Fhospital and undergo sampling of serum and nasal swab\n4. Informed Consent Available\n\n   Key Exclusion Criteria:\n5. Any acute or chronic conditions that could limit the ability of the patient to participate in the study.\n6. Refusal to give informed consent.",{"count":56,"type":21},60,[58],"NA","Focal cortical dysplasia (FCD) is a malformation of brain development, the most common cause of drug-resistant epilepsy and often caused by mutations in mammalian target of rapamycin (mTOR) pathway genes. Patients with FCD develop drug-resistant seizures. This study will look at FCD tissue removed during epilepsy surgery and aims to detect mutations in mTOR pathway genes in brain cells. Secondly, the investigators will establish if evidence of mutations found in brain cells can also be detected as circulating free DNA (cfDNA) in blood. By looking at which genes are made into proteins in individual cells found in epilepsy surgical tissue (single cell expression profiling),the investigators will attempt to identify new genetic targets in FCD.\n\nThe main outcome will be finding new causes of epilepsy with FCD and the development of new diagnostic and screening tools.",[28,61],"Epilepsy","RECRUITING","2024-10-21",{"date":65,"type":39},"2024-10-23",{"date":67,"type":39},"2023-04-09",{"date":69,"type":21},"2026-04-08",{"name":71,"class":72},"King's College Hospital NHS Trust","OTHER",1]