Recruiting

Phase 3

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

Sponsor:

Neurona Therapeutics

Code:

NCT05135091

Conditions

Mesial Temporal Lobe Epilepsy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

NRTX-1001

Sham Comparator

Study Details

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).

Conditions

Mesial Temporal Lobe Epilepsy

Study ID

NCT05135091

Start date

Jun 16, 2022

Status verified date

Mar, 2026

Completion date

Sep, 2043

Anticipated

Primary completion date

Feb, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

88 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NRTX-1001 (Phase 1/2)

Up to 28 subjects

experimental: NRTX-1001 (Phase 3)

Approximately 40 subjects

sham comparator: Sham Comparator (Phase 3)

Approximately 20 subjects

Interventions

NRTX-1001

Biological: NRTX-1001 is an experimental neural cell therapy product candidate derived from an allogeneic human embryonic stem cell line. The stem cells were converted into inhibitory nerve cells that produce GABA.

NRTX-1001

Sham Comparator

Primary outcome measure

Frequency of serious or severe AEs (Phase 1/2) [ Time Frame: 1 year ]
Change in disabling seizure frequency (Phase 3) [ Time Frame: 4-6 months after surgery ]

Central Contacts and Locations

Central contacts

Neurona MedInfo

650-580-3825 neuronamedinfo@neuronatx.com

Eduardo Dunayevich, MD

650-436-3045 edunayevich@neuronatx.com

Locations

University of Alabama

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Jennifer Pilkington, SC

jlpilkington@uabmc.edu

Principal Investigator:

Jerzy Szaflarski, MD, PhD

Mayo Clinic Arizona Epilepsy Center

Recruiting

Phoenix, Arizona, United States, 85054

Contacts

Kayla N Haeger, BSN, RN

480-342-5075 Haeger.Kayla@mayo.edu

Principal Investigator:

Jonathon J Parker, MD, PhD

Banner-University of Arizona Medical Center Tucson Comprehensive Epilepsy Program

Recruiting

Tucson, Arizona, United States, 85724-5023

Contacts

Faten Sebaali, BA/MA

(520) 626-3576 fsebaali@arizona.edu

Principal Investigator:

David Labiner, MD

University of Arkansas for Medical Sciences

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Shellah Rogers, Nurse

501-614-2086 Scrogers2@uams.edu

Principal Investigator:

Sisira Yadala, MD

University of Southern California Keck Hospital

Recruiting

Los Angeles, California, United States, 90033

Contacts

Zoe B Durkin, SC

213-631-8487 zoe.durkin@med.usc.edu

Principal Investigator:

Charles Y Liu, MD, PhD

University of California Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Elizabeth Cruz

310-825-6930 ElizabethCruz@mednet.ucla.edu

Principal Investigator:

John M Stern, MD

UC Irvine Medical Center

Recruiting

Orange, California, United States, 92868

Contacts

UCI Alpha Clinic

949-824-3990 alphaclinic@hs.uci.edu

Principal Investigator:

Mona Sazgar, MD

Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

Jordan Seliger, CRC, MA

650-460-9260 jseliger@stanford.edu

Principal Investigator:

Kevin Graber, MD

University of California Davis

Recruiting

Sacramento, California, United States, 95817

Contacts

Evan Y Shen, BA

916-734-3009 evshen@ucdavis.edu

Principal Investigator:

Jack J Lin, MD

University of California San Diego

Recruiting

San Diego, California, United States, 92037

Contacts

Mateo Santizo

858-583-0929 msantizo@health.ucsd.edu

Principal Investigator:

Jerry J Shih, MD

University of California San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Sydnie Beausoleil

631-428-9688 Sydnie.Beausoleil@ucsf.edu

Principal Investigator:

Robert C Knowlton, MD

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Trey Jouard, MS

970-817-4272 Trey.Jouard@cuanschutz.edu

Principal Investigator:

Lesley Kaye, MD

George Washington University

Recruiting

Washington D.C., District of Columbia, United States, 20037

Contacts

Preethy Feit, SC

202-677-6765 pfeit@mfa.gwu.edu

Principal Investigator:

Mohamad Koubeissi, MD

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Letitia Fisher

305-775-8582 lfisher@miami.edu

Principal Investigator:

Jonathan R. Jagid, MD

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Amanda Sremac, BS

312-942-0539 Amanda_C_Sremac@rush.edu

Principal Investigator:

Rebecca O'Dwyer, MD

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Agnieszka Stadnik, MS

773-702-8996 astadnik@bsd.uchicago.edu

Principal Investigator:

Peter Warnke, MD

University of Iowa Health Care

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Loraine Brenner, MSN

319-356-4361 loraine-brenner@uiowa.edu

Principal Investigator:

Mark Granner, MD

Ochsner Clinic Foundation

Recruiting

New Orleans, Louisiana, United States, 70121

Contacts

Neydin Osorio, BS, CRC

504-703-5577 neydin.tejeda@ochsner.org

Principal Investigator:

Fawad Khan, MD

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Anna George, MSc

617-632-7031 ageorge5@bidmc.harvard.edu

Principal Investigator:

Joshua P Aronson, MD

Wayne State University/Detroit Medical Center Comprehensive Epilepsy Program

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Kelly X Jia, MD

313-966-9407 xjia@med.wayne.edu

Principal Investigator:

Maysaa Basha, MD

Washington University at St. Louis

Recruiting

St Louis, Missouri, United States, 63100

Contacts

Victoria Taylor, SC

314-362-7871 v.taylor@wustl.edu

Principal Investigator:

R. Edward Hogan, MD

Dartmouth Hitchcock Medical Center/ Department of Neurology

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Anastasia Kanishcheva, PM

603) 650-0260 anastasia.kanishcheva@hitchcock.org

Principal Investigator:

Krzysztof A, Bujarski, MD

Hofstra Northwell Comprehensive Epilepsy Center

Recruiting

Great Neck, New York, United States, 11021

Contacts

Isabella Henderson

212-434-4837 IHenderson@northwell.edu

Principal Investigator:

Sean Hwang, MD

NYU Langone Comprehensive Epilepsy Center

Recruiting

New York, New York, United States, 10016

Contacts

Jack C Carter, BS

646-558-0841 jack.carter@nyulangone.org

Principal Investigator:

Orrin Devinsky, MD

SUNY Upstate Medical University

Recruiting

Syracuse, New York, United States, 13210

Contacts

Lena F Deb, BA

315-464-9756 debl@upstate.edu

Principal Investigator:

Robert L Beach, MD, PhD

Atrium Health

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Dianelis Diaz, RN, BSN, CRC

704-446-1349 dianelis.diaz@atriumhealth.org

Principal Investigator:

Rajdeep Singh, MD

Duke University Hospital

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Hazani Benitez-Rosas

919-681-4974 Hazani.benitez-rosas@duke.edu

Principal Investigator:

Derek Southwell, MD, PhD

Atrium Wake Forest Baptist

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Carolyn W Hedrick, RMA, CCRP

336-716-8694 cwhedric@wakehealth.edu

Principal Investigator:

Gautam S Popli, MBBS, MBA

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Claire Dorfman, BA

971-413-9201 dorfman@ohsu.edu

Principal Investigator:

David C Spencer, MD

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Latasha Adams, MBS

215-955-2606 Latasha.adams2@jefferson.edu

Principal Investigator:

Michael Sperling, MD

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Vamsi Vemireddy, SC

214-645-8159 vamsidhara.vemireddy@utsouthwestern.edu

Principal Investigator:

Sasha Alick-Lindstrom, MD

UTHealth Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Eliana M Klier, PhD

713-500-5442 Eliana.Klier@uth.tmc.edu

Principal Investigator:

Nitin Tandon, MD

University of Utah Health

Recruiting

Salt Lake City, Utah, United States, 84108

Contacts

Laura Beeler, BS

928-530-7990 laura.beeler@hsc.utah.edu

Principal Investigator:

Amir Arain, MD

University of Washington Regional Epilepsy Center

Recruiting

Seattle, Washington, United States, 98104

Contacts

Jennifer Steele, CRC

206-744-2336 recresearch@uw.edu

Principal Investigator:

Shahin Hakimian, MD, PhD

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Sarah Young, MS

414-955-0989 scyoung@mcw.edu

Principal Investigator:

Sean Lew, MD

More Information

Sponsor

Neurona Therapeutics

Last update posted

Jun 9, 2026

Last verified

Mar, 2026

Keywords

Epilepsy
MTLE
seizure
EPIC
focal seizures
hippocampus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by Neurona Therapeutics on 2026-06-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.