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Brain cell injection could tame epilepsy seizures

NCT ID NCT06422923

Disease control Sponsor: Neurona Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests a one-time injection of special nerve cells (NRTX-1001) into both sides of the brain in 10 adults with drug-resistant epilepsy. The cells are designed to calm overactive brain signals by releasing GABA. The main goal is safety, but researchers will also track whether seizures become less frequent.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NRTX-1001 (inhibitory nerve cells that produce GABA)
What this could lead to
If successful, this could point toward a new treatment that reduces or stops seizures without needing daily medication.
What could go wrong
This is an early, small trial with only 10 participants, so results may not apply to everyone. The procedure involves brain injections, which carry risks like bleeding or infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Jun 2042

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. Male or female, age 18-75 years. 2. Subjects of childbearing potential will use highly effective contraception. 3. 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). 4. Either 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 2. bilateral temporal hypometabolism on 18-Flourodeoxyglucose Positron Emission Tomography (FDG PET) (assessed by visual assessment, comparing temporal regions to frontal/parietal lobe neocortex). In this case, ictal EEG recordings must also include intracranial confirmation. or 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. 5. 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. 6. Subject has previously had adequate (in opinion of investigator) therapeutic trials of at least two Anti-Seizure Medicines (ASMs). 7. 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. 8. Subject can converse and read in English or Spanish. Able to participate in required study procedures and provide signed informed consent. Key Exclusion Criteria: 1. Epilepsy due to other and/or progressive neurologic disease. 2. Evidence of seizure focus outside hippocampus (either by seizure semiology or EEG findings). 3. 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 (\<2 cm) non invasive meningioma, remote from the affected temporal lobe, is not exclusionary. 4. Seizures of non-focal origin. 5. 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. 6. Psychogenic Non-Epileptic Seizures (PNES) within the past 3 years. 7. Severe psychiatric disorders. 8. Primary or secondary immunodeficiency. 9. Pregnancy, or currently breastfeeding. 10. Suicide attempts in past year. 11. Significant other medical conditions which would impair safe participation.

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Conditions

The condition(s) this trial relates to.

mesial temporal lobe epilepsy with hippocampal sclerosis temporal lobe epilepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Epilepsy, temporal lobe

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    16 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Atrium Health

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Duke University Hospital

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Oregon Health and Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • SUNY Upstate Medical University

    RECRUITING

    Syracuse, New York, 13210, United States

  • Stanford University

    RECRUITING

    Palo Alto, California, 94304, United States

  • UC Irvine Medical Center

    RECRUITING

    Orange, California, 92868, United States

  • UTHealth Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • UVA Health University Medical Center

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • University of Arkansas for Medical Sciences

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • University of California San Diego

    RECRUITING

    San Diego, California, 92037, United States

  • University of California San Francisco

    WITHDRAWN

    San Francisco, California, 94143, United States

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Colorado Anschutz Medical Campus

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Iowa Health Care

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Southern California Keck Hospital

    RECRUITING

    Los Angeles, California, 90033, United States

  • Wake Forest Baptist Medical Center

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

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