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NCT05135091 · ClinicalTrials.gov registry record · Phase 3
Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (EPIC (EPIlepsy Cell Therapy))
A Phase 3 study of Mesial Temporal Lobe Epilepsy, sponsored by Neurona Therapeutics.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 88
- Enrollment target
- 20
- Study locations
NCT05135091: Recruiting Phase 3 study of Mesial Temporal Lobe Epilepsy, sponsored by Neurona Therapeutics.
NCT05135091 is a Phase 3 study of Mesial Temporal Lobe Epilepsy that is actively recruiting participants, run by Neurona Therapeutics. The registered enrollment target is 88 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05135091, a Phase 3 study of Mesial Temporal Lobe Epilepsy, is actively recruiting participants, sponsored by Neurona Therapeutics.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 88 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Primary Outcome
The primary endpoint of the study is the frequency of serious or severe AEs over the period of 1 year after administration.
Conditions Studied
Interventions
- BIOLOGICAL NRTX-1001
- PROCEDURE Sham Comparator
Study Locations (20)
California
- University of Southern California Keck Hospital - Los Angeles
- University of California Los Angeles - Los Angeles
- UC Irvine Medical Center - Orange
- Stanford University - Palo Alto
- University of California Davis - Sacramento
- University of California San Diego - San Diego
- University of California San Francisco - San Francisco
Arizona
- Mayo Clinic Arizona Epilepsy Center - Phoenix
- Banner-University of Arizona Medical Center Tucson Comprehensive Epilepsy Program - Tucson
Illinois
- Rush University Medical Center - Chicago
- University of Chicago - Chicago
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Colorado
- University of Colorado Anschutz Medical Campus - Aurora
District of Columbia
- George Washington University - Washington D.C.
Florida
- University of Miami - Miami
Iowa
- University of Iowa Health Care - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2022-06-16 |
| Est. Completion | 2043-09 |
| Phase | Phase 3 |
What NCT05135091 shows while recruiting
NCT05135091 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Mesial Temporal Lobe Epilepsy appearing as the primary indexed condition, and to 2 interventions - of which NRTX-1001 is the first listed.
NCT05135091 names 20 study sites across 12 states, led by California, Arizona, Illinois.
Frequently Asked Questions
What is clinical trial NCT05135091 about?
NCT05135091 is a clinical study titled "Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (EPIC (EPIlepsy Cell Therapy))". 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 (...
What is the current status of trial NCT05135091?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 88 participants. The study started on 2022-06-16. Estimated completion is 2043-09.
What conditions does trial NCT05135091 study?
This clinical trial studies the following conditions: Mesial Temporal Lobe Epilepsy.
What interventions are being tested in trial NCT05135091?
The interventions under investigation include: NRTX-1001 (BIOLOGICAL), Sham Comparator (PROCEDURE).
Who is sponsoring clinical trial NCT05135091?
This trial is sponsored by Neurona Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05135091 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05135091's enrollment target sits among peer trials
88 1740th of 2000 higher than 259 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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