RecruitingPhase 3interventionalRules rewrite

Phase 3: testing NRTX-1001 for Mesial Temporal Lobe Epilepsy

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 side effects) and effective (seizure frequency). NRTX-1001 comprises human interneurons that secrete a neurotransmitter, gamma-aminobutyric acid (GABA).

Official registry: https://clinicaltrials.gov/study/NCT05135091 · Neurona Therapeutics · enrollment listed as 88

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are NRTX-1001, NRTX-1001, or Sham Comparator. The registry lists allocation as randomized. 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 side effects) and effective (seizure frequency).

They plan to enroll about 88 people at 36 sites. Taking part typically means an infusion or injection of a biologic, a procedure as part of the study plus check-ins.

Official title (unrewritten)

A Study of Inhibitory Interneurons (NRTX-1001) in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (MTLE)

Interventions: NRTX-1001, NRTX-1001, Sham Comparator

Primary outcome (registry wording): Frequency of serious or severe AEs (Phase 1/2)

Who it is for (from inclusion criteria)

Ages 18 Years to 75 Years
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)

Who the registry excludes

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
History of status epilepticus in the 3 years prior to screening
Primary or secondary immunodeficiency
Suicide attempts in the past year 3 years
Severe psychiatric disorders

Public study contact (from the registry)

Neurona MedInfo

650-580-3825

neuronamedinfo@neuronatx.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

36 listed

University of Alabama — Birmingham, Alabama (recruiting)
Mayo Clinic Arizona Epilepsy Center — Phoenix, Arizona (recruiting)
Banner-University of Arizona Medical Center Tucson Comprehensive Epilepsy Program — Tucson, Arizona (recruiting)
University of Arkansas for Medical Sciences — Little Rock, Arkansas (recruiting)
University of Southern California Keck Hospital — Los Angeles, California (recruiting)
University of California Los Angeles — Los Angeles, California (recruiting)
UC Irvine Medical Center — Orange, California (recruiting)
Stanford University — Palo Alto, California (recruiting)
University of California Davis — Sacramento, California (recruiting)
University of California San Diego — San Diego, California (recruiting)
University of California San Francisco — San Francisco, California (recruiting)
University of Colorado Anschutz Medical Campus — Aurora, Colorado (recruiting)

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FAQ about this NCT record

Is NCT05135091 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05135091?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05135091?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary