Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy… (NCT05135091) | Clinical Trial Compass
RecruitingPhase 3
Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (EPIC (EPIlepsy Cell Therapy))
United States88 participantsStarted 2022-06-16
Plain-language 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).
Who can participate
Age range18 Years – 75 Years
SexALL
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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)
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.