Neural cell therapy for drug-resistant epilepsy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial tests the safety and effectiveness of NRTX-1001, a therapy involving the administration of inhibitory nerve cells into the brain of patients with drug-resistant unilateral mesial temporal lobe epilepsy (MTLE). Participants will receive a single image-guided intracerebral injection of human interneurons that secrete GABA, aimed at reducing seizure frequency. The study will monitor participants for safety and seizure control over a two-year period, followed by long-term follow-up. An immunosuppressant regimen will be used to enhance the persistence of the injected cells.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. Male or Female, age ≥18 to ≤75
2. Focal seizures, clinically defined as unilateral MTLE
3. Has failed to achieve seizure control despite adequate trials of at least 2 ASDs at appropriate doses
4. Currently on stable doses (at least 1 month prior to Screening) of approved ASDs
5. Single seizure focus confirmed within one hippocampus
6. 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)
7. 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)

Key Exclusion Criteria:

1. Epilepsy due to other medical conditions and/or progressive neurologic disease
2. Evidence of seizure focus outside of the hippocampus or evidence of seizures of non- focal origin.
3. Significant other medical conditions which would impair safe participation
4. History of status epilepticus in the 3 years prior to screening.
5. Primary or secondary immunodeficiency
6. Suicide attempts in the past year 3 years
7. Severe psychiatric disorders
8. Prior lobectomy or LITT procedure
9. MRI indicating potential malignant lesion
10. Pregnancy, or currently breastfeeding.

Where it's running

• University of Alabama
  Birmingham, Alabama, United States Recruiting
• Mayo Clinic Arizona Epilepsy Center
  Phoenix, Arizona, United States Recruiting
• Banner-University of Arizona Medical Center Tucson Comprehensive Epilepsy Program
  Tucson, Arizona, United States Recruiting
• University of Arkansas for Medical Sciences
  Little Rock, Arkansas, United States Recruiting
• University of Southern California Keck Hospital
  Los Angeles, California, United States Recruiting
• University of California Los Angeles
  Los Angeles, California, United States Recruiting

Study contacts

• Study coordinator: Neurona MedInfo
• Email: neuronamedinfo@neuronatx.com
• Phone: 650-580-3825

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Gene therapy for adults with refractory mesial temporal lobe epilepsy

  This study is testing a new gene therapy called AMT-260 to see if it can help adults with a type of epilepsy called mesial temporal lobe epilepsy by reducing their seizures.

  Recruiting at 16 sites Phase 1/2 UniQure Biopharma B.V. · Birmingham, Alabama and 17 other locations · NCT06063850

• Using Deep Brain Stimulation to Preserve Memory in Epilepsy

  This study is testing whether a new brain stimulation technique can help people with Mesial Temporal Lobe Epilepsy have fewer seizures and better memory.

  Recruiting at 2 sites The University of Texas Health Science Center, Houston · Rochester, Minnesota and 1 other locations · NCT05608408

• Neuronal cell therapy for drug-resistant epilepsy

  This study is testing a new treatment that involves giving special nerve cells to people with hard-to-treat epilepsy to see if it can help reduce their seizures.

  Recruiting at 16 sites Phase 1/2 Neurona Therapeutics · Little Rock, Arkansas and 16 other locations · NCT06422923

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.