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Young","414-955-0989","scyoung@mcw.edu",{"name":338,"role":55,"phone":31,"phoneExt":31,"email":31},"Kunal Gupta, MD, PhD",{"type":340,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100520998","phase-1-amt-260-gene-therapy-study-in-adults-with-unilateral-refractory-mesial-temporal-lobe-epilepsy-100520998",false,"NCT06063850","AMT-260 Gene Therapy Study in Adults With Unilateral Refractory Mesial Temporal Lobe Epilepsy","A Multi-center, Phase 1\u002F2a, First-in-human (FIH) Study Investigating the Safety, Tolerability, and Efficacy of AMT-260 in Adults With Unilateral Refractory Mesial Temporal Lobe Epilepsy (MTLE) Administered Via Magnetic Resonance Imaging (MRI)-Guided Convection-enhanced Delivery (CED)","GenTLE","Inclusion Criteria:\n\n* Diagnosis of unilateral refractory MTLE\n* History of seizures with an average of ≥ 2 documented focal impaired awareness seizures or focal to bilateral tonic-clonic seizures per 30-day period over the 3 month Retrospective Period.\n* On a stable type and dose regimen of up to a maximum of 4 approved Anti Seizure Drugs for at least 1 month prior to the Retrospective Period.\n* Confirmed unilateral hippocampal pathology and concordant unilateral seizure focus\n* No evidence of focal neurocognitive dysfunction, inconsistent with disease pathology- related MRI and\u002For (18F)FDG-PET findings.\n* Women of childbearing potential (WOCBP) and fertile male subjects must be willing and able to use highly effective methods of birth control consistently and correctly throughout the study.\n* For WOCBP only: Negative pregnancy test.\n\nExclusion Criteria:\n\n* Implanted devices that would contraindicate MRI; MRI-compatible devices must be implanted ≥3 months prior to Screening (vagus nerve stimulation devices will be up to discretion of the Investigator).\n* Any other contraindications to general anesthesia, surgery, or intra-operative magnetic resonance imaging (MRI).\n* Medications that could confound clinical (e.g., antipsychotic medication and anti-viral therapy) and laboratory evaluations or could affect a participant's safety or their ability to undergo the neurosurgical procedure or comply with the procedures and study visit schedule.\n* Bilateral or multifocal epilepsy; or inability to confidently lateralize seizure onset.\n* Dementia or other progressive neurological disorders and progressive brain lesions.\n* Previous major disease-unrelated neurosurgical intervention due to intracranial tumor, trauma, or bleeding and\u002For history of previous intracranial surgery for treatment of epileptic seizures, not including diagnostic stereo-EEG.\n* MRI evidence of epileptogenic, extra-temporal lesions, or dual temporal lobe pathology.\n* Status epilepticus within the year prior to Screening.","ALL","18 Years","75 Years",{"count":353,"type":354},12,"ESTIMATED","INTERVENTIONAL",[357,358],"PHASE1","PHASE2","The main goals of this clinical study are to learn if AMT-260 is safe and tolerable and works to reduce the frequency of seizures in adults with unilateral mesial temporal lobe epilepsy (MTLE).",[361],"Mesial Temporal Lobe Epilepsy",[363,364,365,366],"Epilepsy","Temporal Lobe","Hippocampal Sclerosis","Epileptic Syndromes","2026-05-28",{"date":369,"type":370},"2026-06-02","ACTUAL",{"date":372,"type":370},"2024-06-12",{"date":374,"type":354},"2031-12",{"name":5,"class":6},18]