Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 3

Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (EPIC (EPIlepsy Cell Therapy))

NCT05135091 · View on ClinicalTrials.gov ↗

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).

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

FieldValue
Enrollment Target 88 participants
Start Date 2022-06-16
Est. Completion 2043-09
Phase Phase 3

Sponsor

Neurona Therapeutics

33 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05135091

The ClinicalTrials.gov registry entry for NCT05135091 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Neurona Therapeutics, which has 33 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05135091 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Arizona, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05135091?

The interventions under investigation include: NRTX-1001 (BIOLOGICAL), Sham Comparator (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05135091?

This trial is sponsored by Neurona Therapeutics, which has 33 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial