Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (EPIC (EPIlepsy Cell Therapy))
Recruiting · NCT05135091 · Interventional (participants receive a specific treatment) · Lead sponsor: Neurona Therapeutics
View the official record on ClinicalTrials.gov →Interventions studied
NRTX-1001Sham Comparator
What this trial is about
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 take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
35 locations listed across 22 US states.
- University of Alabama - Birmingham, Alabama, United States
- Mayo Clinic Arizona Epilepsy Center - Phoenix, Arizona, United States
- Banner-University of Arizona Medical Center Tucson Comprehensive Epilepsy Program - Tucson, Arizona, United States
- University of Arkansas for Medical Sciences - Little Rock, Arkansas, United States
- University of Southern California Keck Hospital - Los Angeles, California, United States
- University of California Los Angeles - Los Angeles, California, United States
- UC Irvine Medical Center - Orange, California, United States
- Stanford University - Palo Alto, California, United States
- University of California Davis - Sacramento, California, United States
- University of California San Diego - San Diego, California, United States
- University of California San Francisco - San Francisco, California, United States
- University of Colorado Anschutz Medical Campus - Aurora, Colorado, United States
- George Washington University - Washington D.C., District of Columbia, United States
- University of Miami - Miami, Florida, United States
- Rush University Medical Center - Chicago, Illinois, United States
- University of Chicago - Chicago, Illinois, United States
- University of Iowa Health Care - Iowa City, Iowa, United States
- Ochsner Clinic Foundation - New Orleans, Louisiana, United States
- Beth Israel Deaconess Medical Center - Boston, Massachusetts, United States
- Wayne State University/Detroit Medical Center Comprehensive Epilepsy Program - Detroit, Michigan, United States
- Washington University at St. Louis - St Louis, Missouri, United States
- Dartmouth Hitchcock Medical Center/ Department of Neurology - Lebanon, New Hampshire, United States
- Hofstra Northwell Comprehensive Epilepsy Center - Great Neck, New York, United States
- NYU Langone Comprehensive Epilepsy Center - New York, New York, United States
- SUNY Upstate Medical University - Syracuse, New York, United States
- Atrium Health - Charlotte, North Carolina, United States
- Duke University Hospital - Durham, North Carolina, United States
- Atrium Wake Forest Baptist - Winston-Salem, North Carolina, United States
- Oregon Health and Science University - Portland, Oregon, United States
- Thomas Jefferson University Hospital - Philadelphia, Pennsylvania, United States
- UT Southwestern Medical Center - Dallas, Texas, United States
- UTHealth Houston - Houston, Texas, United States
- University of Utah Health - Salt Lake City, Utah, United States
- University of Washington Regional Epilepsy Center - Seattle, Washington, United States
- Medical College of Wisconsin - Milwaukee, Wisconsin, United States