FIH Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy
Trial ID or NCT#
Status
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
- 1. Male or Female, age ≥18 to 652. Focal seizures, clinically defined as TLE3. Has failed to achieve seizure control despite adequate trials of at least 2 ASDs at appropriate doses4. Currently on stable doses (at least 1 month) of approved ASDs5. Single seizure focus confirmed as within one temporal lobe6. 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
- 1. Epilepsy due to other and/or progressive neurologic disease2. Significant other medical condition which would impair safe participation3. Primary or secondary immunodeficiency4. Suicide attempt in the past year5. Severe psychiatric disorders6. Chronic indwelling intracranial device7. MRI indicating potential malignant lesion8. Pregnancy, or currently breastfeeding
Investigator(s)
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Contact
Jordan Seliger, CRC, MA
650-460-9260
View on ClinicalTrials.gov