Actively Recruiting
A Phase 1/2 Study of NRTX-1001 Neuronal Cell Therapy in Drug-Resistant Bilateral Mesial Temporal Lobe Epilepsy (MTLE)
Led by Neurona Therapeutics · Updated on 2026-01-07
10
Participants Needed
17
Research Sites
917 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, single arm, open label clinical trial that is designed to test the safety and preliminary efficacy of single administration inhibitory nerve cells called interneurons (NRTX-1001), into both temporal lobes of subjects with drug-resistant bilateral mesial temporal lobe epilepsy.
CONDITIONS
Official Title
A Phase 1/2 Study of NRTX-1001 Neuronal Cell Therapy in Drug-Resistant Bilateral Mesial Temporal Lobe Epilepsy (MTLE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, age 18-75 years
- Subjects of childbearing potential must use highly effective contraception
- Proven history of focal seizures of hippocampal origin with bilateral seizure foci confirmed by scalp or intracranial ictal EEG
- Evidence of bilateral hippocampal sclerosis on MRI or bilateral temporal hypometabolism on FDG PET, or a combination of unilateral evidence from both, with scans acquired within 3 years
- At least four clinical focal seizures per month on average, including at least two with objective manifestations, during the 6 months before screening
- Previous therapeutic trials of at least two anti-seizure medicines
- Stable doses of current anti-seizure medicines and other drugs affecting seizure frequency for at least 3 months before enrollment
- Ability to converse and read in English or Spanish and provide signed informed consent
You will not qualify if you...
- Epilepsy caused by other or progressive neurologic diseases
- Evidence of seizure focus outside the hippocampus
- MRI showing potential malignant lesions or non-malignant epileptogenic lesions outside the hippocampus (except small meningiomas remote from the temporal lobe)
- Seizures of non-focal origin
- History of status epilepticus in the past year
- Psychogenic non-epileptic seizures within the past 3 years
- Severe psychiatric disorders
- Primary or secondary immunodeficiency
- Pregnancy or currently breastfeeding
- Suicide attempts in the past year
- Other significant medical conditions impairing safe participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Actively Recruiting
2
University of Southern California Keck Hospital
Los Angeles, California, United States, 90033
Actively Recruiting
3
UC Irvine Medical Center
Orange, California, United States, 92868
Actively Recruiting
4
Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
5
University of California San Diego
San Diego, California, United States, 92037
Actively Recruiting
6
University of California San Francisco
San Francisco, California, United States, 94143
Withdrawn
7
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
8
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
9
University of Iowa Health Care
Iowa City, Iowa, United States, 52242
Actively Recruiting
10
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Actively Recruiting
11
Atrium Health
Charlotte, North Carolina, United States, 28204
Actively Recruiting
12
Duke University Hospital
Durham, North Carolina, United States, 27710
Actively Recruiting
13
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
14
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
15
UTHealth Houston
Houston, Texas, United States, 77030
Actively Recruiting
16
UVA Health University Medical Center
Charlottesville, Virginia, United States, 22903
Actively Recruiting
17
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
N
Neurona MedInfo
CONTACT
E
Eduardo Dunayevich, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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