Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (EPIC (EPIlepsy Cell Therapy))

About

Brief Summary

This clinical trial is designed to test whether a single image-guided intracerebral administration of inhibitory nerve cells, called interneurons (NRTX-1001), into subjects with drug-resistant unilateral mesial temporal lobe epilepsy (MTLE), with or without mesial temporal sclerosis (MTS), is safe (frequency of adverse events) and effective (seizure frequency). NRTX-1001 comprises human interneurons that secrete a neurotransmitter, gamma-aminobutyric acid (GABA).

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 3

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

75 Years

Key Inclusion Criteria:

Male or Female, age ≥18 to ≤75
Focal seizures, clinically defined as unilateral MTLE
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 prior to Screening) of approved ASDs
Single seizure focus confirmed within one hippocampus
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)
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:

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