FIH Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy

a study on Epilepsy

Summary

Eligibility
for people ages 18-65 (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around
Principal Investigator
by John M Stern, MD

Description

Summary

This clinical trial is designed to test whether a single stereotactic intracerebral administration of inhibitory nerve cells into subjects with drug-resistant mesial temporal lobe epilepsy is safe (frequency of adverse events) and effective (seizure frequency).

Official Title

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

Details

Subjects will undergo a single stereotactic intracerebral administration of neural cells, called interneurons, that secrete the inhibitory neurotransmitter gamma-aminobutyric acid (GABA).

Subjects will then take medicines to partially suppress their immune system (aimed to prevent the body from rejecting the cells) for 1 year. Safety, tolerability, evidence of neural cell viability and local inflammation (using MRI scans of the brain), and effects on epilepsy disease symptoms will be assessed for 2 years post-transplant. Subjects will be followed for an additional 13 years with quarterly phone contact and annual visits.

Keywords

Mesial Temporal Lobe Epilepsy With Hippocampal Sclerosis, Epilepsy, Temporal Lobe Epilepsy, Hippocampal Sclerosis, NRTX-1001

Eligibility

You can join if…

Open to people ages 18-65

  1. Male or Female, age ≥18 to 65
  2. Focal seizures, clinically defined as TLE
  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) of approved ASDs
  5. Single seizure focus confirmed as within one temporal lobe
  6. For subjects entering Stage 1, the seizure focus is either a) in the non-dominant hemisphere, or b) in the dominant hemisphere and the subject has a Rey Auditory Verbal Learning Test (RAVLT) assessed within one year of screening, or at the screening visit, that is at least 1.5 standard deviations below the population mean.
  7. Seizure frequency averages ≥2 per 28-day period over the 6 months prior to screening.

You CAN'T join if...

  1. Epilepsy due to other and/or progressive neurologic disease
  2. Significant other medical condition which would impair safe participation
  3. Primary or secondary immunodeficiency
  4. Suicide attempt in the past year
  5. Severe psychiatric disorders
  6. Chronic indwelling intracranial device
  7. MRI indicating potential malignant lesion
  8. Pregnancy, or currently breastfeeding

Locations

  • University of California Los Angeles accepting new patients
    Los Angeles California 90095 United States
  • University of California San Diego accepting new patients
    San Diego California 92037 United States

Lead Scientist at UCLA

  • John M Stern, MD
    Professor of Clinical, Neurology, Medicine. Authored (or co-authored) 107 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Neurona Therapeutics
ID
NCT05135091
Phase
Phase 1/2 Epilepsy Research Study
Study Type
Interventional
Participants
Expecting 40 study participants
Last Updated