Tests NRTX-1001 cell therapy for drug-resistant temporal lobe epilepsy
Tests injected inhibitory nerve cells in adults with drug-resistant temporal lobe epilepsy.
Plain-language title generated from the registry record
Registry title: Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (EPIC (EPIlepsy Cell Therapy))
Key facts
- Where
- Aurora, Birmingham, Boston, Buffalo, Charlotte, Chicago, Dallas, Detroit, Durham, Great Neck, Houston, Iowa City, Lebanon, Little Rock, Los Angeles, Miami, Milwaukee, New Orleans, New York, Orange, Palo Alto, Philadelphia, Phoenix, Portland, Sacramento, Salt Lake City, San Diego, San Francisco, Seattle, St Louis, Syracuse, Tucson, Washington D.C., and Winston-Salem, United StatesSee the 36 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT05135091, who can take part
Where in United States
- University of Colorado Anschutz Medical CampusAurora, United StatesTaking people
- University of AlabamaBirmingham, United StatesTaking people
- Beth Israel Deaconess Medical CenterBoston, United StatesTaking people
- Kaleida HealthBuffalo, United StatesTaking people
- Atrium HealthCharlotte, United StatesTaking people
- Rush University Medical CenterChicago, United StatesTaking people
- University of ChicagoChicago, United StatesTaking people
- UT Southwestern Medical CenterDallas, United StatesTaking people
- Wayne State University/Detroit Medical Center Comprehensive Epilepsy ProgramDetroit, United StatesTaking people
- Duke University HospitalDurham, United StatesTaking people
- Hofstra Northwell Comprehensive Epilepsy CenterGreat Neck, United StatesTaking people
- UTHealth HoustonHouston, United StatesTaking people
- University of Iowa Health CareIowa City, United StatesTaking people
- Dartmouth Hitchcock Medical Center/ Department of NeurologyLebanon, United StatesTaking people
- University of Arkansas for Medical SciencesLittle Rock, United StatesTaking people
- University of California, Los AngelesLos Angeles, United StatesTaking people
- University of Southern California Keck HospitalLos Angeles, United StatesTaking people
- University of MiamiMiami, United StatesTaking people
- Medical College of WisconsinMilwaukee, United StatesTaking people
- Ochsner Clinic FoundationNew Orleans, United StatesTaking people
- NYU Langone Comprehensive Epilepsy CenterNew York, United StatesTaking people
- UC Irvine Medical CenterOrange, United StatesTaking people
- Stanford UniversityPalo Alto, United StatesTaking people
- Thomas Jefferson University HospitalPhiladelphia, United StatesTaking people
- Mayo Clinic Arizona Epilepsy CenterPhoenix, United StatesTaking people
- Oregon Health and Science UniversityPortland, United StatesTaking people
- University of California - DavisSacramento, United StatesTaking people
- University Of Utah HealthSalt Lake City, United StatesTaking people
- University of California San DiegoSan Diego, United StatesTaking people
- University of California San FranciscoSan Francisco, United StatesTaking people
- University of Washington Regional Epilepsy CenterSeattle, United StatesTaking people
- Washington University at St. LouisSt Louis, United StatesTaking people
- SUNY Upstate Medical UniversitySyracuse, United StatesTaking people
- Banner-University of Arizona Medical Center Tucson Comprehensive Epilepsy ProgramTucson, United StatesTaking people
- George Washington UniversityWashington D.C., United StatesTaking people
- Atrium Wake Forest BaptistWinston-Salem, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Neurona Therapeutics
- Trial code
- NCT05135091
- Record updated
- 30 October 2026
- Original description
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).Read full original descriptionShow less
A Study of Inhibitory Interneurons (NRTX-1001) in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (MTLE)
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).
Inclusion: Male or Female, age ≥18 to ≤75; Focal seizures, clinically defined as unilateral MTLE; Has failed to achieve seizure control despite adequate trials of at least 2 ASDs at appropriate doses; Currently on stable doses (at least 1 month prior to Screening) of approved ASDs; Single seizure focus confirmed within one hippocampus; 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 1/2 only); 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).
Exclusion: History of status epilepticus in the 3 years prior to screening; Prior lobectomy or LITT procedure; Epilepsy due to other medical conditions and/or progressive neurologic disease; Evidence of seizure focus outside of the hippocampus or evidence of seizures of non- focal origin; Significant other medical conditions which would impair safe participation; Severe psychiatric disorders; MRI indicating potential malignant lesion; Primary or secondary immunodeficiency; Suicide attempts in the past year 3 years; Pregnancy, or currently breastfeeding.