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

NCT05135091

RecruitingPhase 3

Sponsor: Neurona Therapeutics

Conditions: Mesial Temporal Lobe Epilepsy

Interventions: NRTX-1001, NRTX-1001, Sham Comparator

Countries: United States

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Key Inclusion Criteria:

1. Male or Female, age ≥18 to ≤75
2. Focal seizures, clinically defined as unilateral MTLE
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 prior to Screening) of approved ASDs
5. Single seizure focus confirmed within one hippocampus
6. 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)
7. 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:

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

Locations (35)

Birmingham, Alabama, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Los Angeles, California, United States
Los Angeles, California, United States
Orange, California, United States
Palo Alto, California, United States
Sacramento, California, United States
San Diego, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
Washington D.C., District of Columbia, United States
Miami, Florida, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Iowa City, Iowa, United States
New Orleans, Louisiana, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
St Louis, Missouri, United States
Lebanon, New Hampshire, United States
Great Neck, New York, United States
New York, New York, United States
Syracuse, New York, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Winston-Salem, North Carolina, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
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