Open
Actively Recruiting
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
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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.
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Study Stats
Protocol No.
21-001132
Category
Brain/Neurological Diseases
Principal Investigator
Contact
Location
- UCLA Westwood