[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Neurona Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":76},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"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":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100548586","phase-1-a-phase-12-study-of-nrtx-1001-neuronal-cell-therapy-in-drug-resistant-bilateral-mesial-temporal-lobe-epilepsy-mtle-100548586","NCT06422923","A Phase 1\u002F2 Study of NRTX-1001 Neuronal Cell Therapy in Drug-Resistant Bilateral Mesial Temporal Lobe Epilepsy (MTLE)","A Phase 1\u002F2 Study of NRTX-1001 Neuronal Cell Therapy in Drug-Resistant Bilateral Temporal Lobe Epilepsy (MTLE)","Key Inclusion Criteria:\n\n1. Male or female, age 18-75 years.\n2. Subjects of childbearing potential will use highly effective contraception.\n3. Proven history of focal seizures of hippocampal origin with bilateral seizure foci confirmed by scalp or intracranial ictal EEG (including confirmation by recordings from responsive neurostimulation \\[RNS\\] electrodes when applicable).\n4. Either\n\n   1. bilateral hippocampal sclerosis on MRI (evidenced by increased FLAIR signal intensity in both hippocampi or by visual assessment showing reduced volume compared to normal) or\n   2. bilateral temporal hypometabolism on 18-Flourodeoxyglucose Positron Emission Tomography (FDG PET) (assessed by visual assessment, comparing temporal regions to frontal\u002Fparietal lobe neocortex). In this case, ictal EEG recordings must also include intracranial confirmation.\n\n      or\n   3. a combination of unilateral instances of the evidence described in a. and b. (e.g., one side can be evidenced by criterion a. and the other side by criterion b.) MRI or PET scans used for assessment must have been acquired within 3 years of screening.\n5. Subject has had at least four clinical focal seizures, including at least two clinical focal seizures with objective manifestations, on average, per month for the 6 months prior to screening.\n6. Subject has previously had adequate (in opinion of investigator) therapeutic trials of at least two Anti-Seizure Medicines (ASMs).\n7. Current ASM regimen, and doses of other drugs known to affect seizure frequency (e.g., antidepressants), have been stable for at least three months prior to enrollment.\n8. Subject can converse and read in English or Spanish. Able to participate in required study procedures and provide signed informed consent.\n\nKey Exclusion Criteria:\n\n1. Epilepsy due to other and\u002For progressive neurologic disease.\n2. Evidence of seizure focus outside hippocampus (either by seizure semiology or EEG findings).\n3. MRI indicating potential malignant lesion (low-grade glioma of any type is excluded) in any location or non-malignant potentially epileptogenic lesion outside the hippocampus. Small (\\\u003C2 cm) non invasive meningioma, remote from the affected temporal lobe, is not exclusionary.\n4. Seizures of non-focal origin.\n5. History of status epilepticus in the year prior to screening, as guided by ILAE criteria (Trinka 2015) in the judgement of the PI. A history of cluster seizures is permitted.\n6. Psychogenic Non-Epileptic Seizures (PNES) within the past 3 years.\n7. Severe psychiatric disorders.\n8. Primary or secondary immunodeficiency.\n9. Pregnancy, or currently breastfeeding.\n10. Suicide attempts in past year.\n11. Significant other medical conditions which would impair safe participation.",{"count":56,"type":22},10,[58,59],"PHASE1","PHASE2","This is a multicenter, single arm, open label clinical trial that is designed to test the safety and preliminary efficacy of single administration inhibitory nerve cells called interneurons (NRTX-1001), into both temporal lobes of subjects with drug-resistant bilateral mesial temporal lobe epilepsy.",[62],"Epilepsy, Temporal Lobe",[64,65,66],"Bilateral Temporal Lobe Epilepsy","Bilateral MTLE","Refractory Bilateral MTLE","2026-01-05",{"date":69,"type":39},"2026-01-07",{"date":71,"type":39},"2024-11-14",{"date":73,"type":22},"2042-06-15",{"name":45,"class":46},17,""]