Open
Actively Recruiting
FIH Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy
About
Brief 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).
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Key Inclusion Criteria:
- Male or Female, age ≥18 to 65
- Focal seizures, clinically defined as TLE
- 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) of approved ASDs
- Single seizure focus confirmed as within one temporal lobe
- 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.
- Seizure frequency averages ≥2 per 28-day period over the 6 months prior to screening.
Key Exclusion Criteria:
- Epilepsy due to other and/or progressive neurologic disease
- Significant other medical condition which would impair safe participation
- Primary or secondary immunodeficiency
- Suicide attempt in the past year
- Severe psychiatric disorders
- Chronic indwelling intracranial device
- MRI indicating potential malignant lesion
- Pregnancy, or currently breastfeeding
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Study Stats
Protocol No.
21-001132
Category
Brain/Neurological Diseases
Principal Investigator
Contact
Location
- UCLA Westwood