[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mesial-temporal-lobe-epilepsy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mesial-temporal-lobe-epilepsy":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,77],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100449638","phase-3-study-of-nrtx-1001-neural-cell-therapy-in-drug-resistant-unilateral-mesial-temporal-lobe-epilepsy-epic-epilepsy-cell-therapy-100449638",false,"NCT05135091","Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (EPIC (EPIlepsy Cell Therapy))","A Study of Inhibitory Interneurons (NRTX-1001) in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (MTLE)","EPIC","Key Inclusion Criteria:\n\n1. Male or Female, age ≥18 to ≤75\n2. Focal seizures, clinically defined as unilateral MTLE\n3. Has failed to achieve seizure control despite adequate trials of at least 2 ASDs at appropriate doses\n4. Currently on stable doses (at least 1 month prior to Screening) of approved ASDs\n5. Single seizure focus confirmed within one hippocampus\n6. Seizure frequency averages ≥4 per 28-day period, including at least 2 clinical focal seizures per 28-day period with objective manifestations or more severe types, over the 6 months prior to the Screening Visit. (Phase 1\u002F2 only)\n7. Disabling seizure frequency of ≥2 per 28-day period averaged over 3 months prior to the Screening visit and over a prospective 10-week baseline period prior to Randomization (Phase 3 Only)\n\nKey Exclusion Criteria:\n\n1. Epilepsy due to other medical conditions and\u002For progressive neurologic disease\n2. Evidence of seizure focus outside of the hippocampus or evidence of seizures of non- focal origin.\n3. Significant other medical conditions which would impair safe participation\n4. History of status epilepticus in the 3 years prior to screening.\n5. Primary or secondary immunodeficiency\n6. Suicide attempts in the past year 3 years\n7. Severe psychiatric disorders\n8. Prior lobectomy or LITT procedure\n9. MRI indicating potential malignant lesion\n10. Pregnancy, or currently breastfeeding.","ALL","18 Years","75 Years",{"count":21,"type":22},88,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This clinical trial is designed to test whether a single image-guided intracerebral administration of inhibitory nerve cells, called interneurons (NRTX-1001), into subjects with drug-resistant unilateral mesial temporal lobe epilepsy (MTLE), with or without mesial temporal sclerosis (MTS), is safe (frequency of adverse events) and effective (seizure frequency). NRTX-1001 comprises human interneurons that secrete a neurotransmitter, gamma-aminobutyric acid (GABA).",[28],"Mesial Temporal Lobe Epilepsy",[30,31,32,15,33,34],"Epilepsy","MTLE","seizure","focal seizures","hippocampus","RECRUITING","2026-06-06",{"date":38,"type":39},"2026-06-09","ACTUAL",{"date":41,"type":39},"2022-06-16",{"date":43,"type":22},"2043-09",{"name":45,"class":46},"Neurona Therapeutics","INDUSTRY",35,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100520998","phase-1-amt-260-gene-therapy-study-in-adults-with-unilateral-refractory-mesial-temporal-lobe-epilepsy-100520998","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.",{"count":57,"type":22},12,[59,60],"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).",[28],[30,64,65,66],"Temporal Lobe","Hippocampal Sclerosis","Epileptic Syndromes","2026-05-28",{"date":69,"type":39},"2026-06-02",{"date":71,"type":39},"2024-06-12",{"date":73,"type":22},"2031-12",{"name":75,"class":46},"UniQure Biopharma B.V.",18,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":23,"phases":87,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":101},"100486002","prime-preserving-memory-in-epilepsy-100486002","NCT05608408","PRIME: PReservIng Memory in Epilepsy","Network Neuro-modulation for Mesial Temporal Lobe Epilepsy","Inclusion Criteria:\n\n* Patients with a presumptive diagnosis of EPH determined by the group of clinicians who participate in patient management conference.\n* Ability to comply with test directions and provide informed consent or assent to the study, i.e. cognitively able to participate in studies \\[typically intelligence quotient (IQ) of 65 or above\\].\n* Relatively preserved verbal memory - as determined via formal neuropsychological evaluation performed by the neuropsychologist. The values must within 1.5 standard deviation (SD) of the mean for verbal memory\n* Proficient in English, as all of our tasks and consent forms will be in English and the inclusion of non-English speakers will introduce another confound in this small sample size and preclude grouped analysis\n* Age 18 - 65 years (we expect the trial to take 5 years and wish to target patients with minimal medical co-morbidities)\n* Must have a minimum of 2 seizures of any type per month - this is essential to be able to detect the impact of neuromodulation on the epilepsy over relatively short intervals of time. Patients with secondary generalized seizures may also be enrolled so long as they have a maximum of 20 generalized seizures in the past 12 months (prior to enrollment), or an average of no more than 3 generalized seizures per month.\n\nExclusion Criteria:\n\n* Impaired reading and cognitive functions (more than 3 standard deviations below the mean, usually an IQ \\\u003C 60), as determined by preoperative neuropsychological testing.\n* Patients with gross structural abnormalities (hamartomata, tumors, vascular malformations, diffuse malformations of cortical development) in the brain that raise the possibility of dual pathology resulting in the epilepsy and by derivation, a larger epilepsy network.\n* Patients with neurological conditions such as recent history (within past 5 years) of a stroke, encephalitis and meningitis. Any patient with a current diagnosis of these conditions will also be excluded.\n* Patients with any episodes of status epilepticus in the past 12 months prior to enrollment.\n* Patients with uncontrolled prominent psychiatric comorbidity that will preclude their meaningful participation.\n* Patients with a Beck Depression Inventory II score at baseline examination greater than or equal to 29 (i.e., severe depression).\n* Patients who have attempted suicide in the past 12 months.\n* Patients with memory impairment due to other neurological conditions such as dementia and Parkinson's disease.\n* Patients who are unable to speak or comprehend English. The inclusion of multiple languages will make task development and grouped comparisons of neuro-psychology data difficult.\n* Patients with cardiac pacemakers, intracranial aneurysm clips, or other potentially mobile implanted metallic devices that are deemed MRI incompatible by the manufactures. The absence of high resolution structural imaging precludes appropriate targeting of the regions of interest.\n* Profound hippocampal sclerosis with prominent atrophy of the majority of the hippocampus (equivalent to ILAE type III).\n* Prior brain surgery for any reason or failed prior brain neuromodulation \\[prior vagus nerve stimulation (VNS) therapy is acceptable so long as it is held constant for the duration of the trial\\].\n* History of or current non-epileptic spells (will confound accuracy of seizure detection with ANT Percept PC and the precision of the estimate of the neuromodulation effect).\n* Patients who are pregnant. All female participants of childbearing potential will be counselled prior to enrollment regarding the unknown risks of treatment on a fetus and the importance of using contraception while they are a subject in this study. If a female participant becomes pregnant during the study, they will returned to FDA-approved ANT stimulation parameters (standard of care).","65 Years",{"count":86,"type":22},8,[88],"NA","In this study, participants will receive unilateral Deep Brain Stimulation (DBS) for treatment of epilepsy, with network-based stimulation targets specifically defined using a stereo-electro-encephalographic evaluation and chronic recordings using the Medtronic Percept™ primary cell (PC) Neurostimulator DBS System with BrainSense™ Technology. The hypothesis is that, compared to no stimulation or to standard duty cycle high frequency stimulation, epilepsy neuromodulation using low frequency stimulation and informed by network architecture in patients with epilepsy that arises in a hippocampus that also subserves memory - epilepsy in a precious hippocampus (EPH) - will result in a significant decrease in seizure frequency and severity, paralleled by a decrease in EEG spike counts and improved memory function.",[28],"2026-04-21",{"date":93,"type":39},"2026-04-27",{"date":95,"type":39},"2023-11-16",{"date":97,"type":22},"2029-03-31",{"name":99,"class":100},"Nitin Tandon","OTHER",2]