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

Trial ID or NCT#

NCT05135091

Status

recruiting iconRECRUITING

Purpose

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)

Eligibility Criteria

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 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. Key
Exclusion Criteria:
  1. 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
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Investigator(s)

Richard Lafayette
Richard Lafayette
Nephrologist
Professor of Medicine (Nephrology)
Jaimie Henderson, MD
Jaimie Henderson, MD
Functional neurosurgeon, Epilepsy neurosurgeon, Pain neurosurgeon, Movement disorders specialist, Deep brain stimulation specialist, Neurosurgeon
John and Jene Blume - Robert and Ruth Halperin Professor, Professor of Neurosurgery and, by courtesy, of Neurology
Vivek P. Buch, MD
Vivek P. Buch, MD
Neurosurgeon
Assistant Professor of Neurosurgery

Contact us to find out if this trial is right for you.

Contact

Jordan Seliger, CRC, MA
650-460-9260

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View on ClinicalTrials.gov