RECRUITING

FIH Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy

Conditions

Mesial Temporal Lobe Epilepsy Epilepsy, MTLE, seizure

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A First-In-Human (FIH) Study of Inhibitory Interneurons (NRTX- 1001) in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (MTLE)

Quick Facts

Study Start:2022-06-16

Study Completion:2042-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05135091

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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) 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. 7. Considered (by Investigator) to be a candidate for temporal lobectomy (TL) or Laser Interstitial Thermal Therapy (LITT) following evaluation at a qualified epilepsy surgery program (National Association of Epilepsy Centers \[NAEC\] Level 4).	1. Epilepsy due to other 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 year prior to screening. A history of cluster seizures is permitted. 5. Primary or secondary immunodeficiency 6. Suicide attempts in the past year 7. Severe psychiatric disorders 8. Prior lobectomy or LITT procedure 9. MRI indicating potential malignant lesion 10. Pregnancy, or currently breastfeeding.

Inclusion Criteria

Exclusion 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) 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.
7. Considered (by Investigator) to be a candidate for temporal lobectomy (TL) or Laser Interstitial Thermal Therapy (LITT) following evaluation at a qualified epilepsy surgery program (National Association of Epilepsy Centers \[NAEC\] Level 4).

1. Epilepsy due to other 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 year prior to screening. A history of cluster seizures is permitted.
5. Primary or secondary immunodeficiency
6. Suicide attempts in the past year
7. Severe psychiatric disorders
8. Prior lobectomy or LITT procedure
9. MRI indicating potential malignant lesion
10. Pregnancy, or currently breastfeeding.

Contacts and Locations

Study Contact

Sheri Madrid, BS, BA

CONTACT

949-500-0027

sheri@neuronatx.com

Manher Joshi, MD

CONTACT

650-455-1495

aj@neuronatx.com

Principal Investigator

John Hixson, MD

STUDY_DIRECTOR

Neurona Therapeutics

Study Locations (Sites)

Mayo Clinic Arizona Epilepsy Center

Phoenix, Arizona, 85054

United States

Banner-University of Arizona Medical Center Tucson Comprehensive Epilepsy Program

Tucson, Arizona, 85724-5023

United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205

United States

University of Southern California Keck Hospital

Los Angeles, California, 90033

United States

University of California Los Angeles

Los Angeles, California, 90095

United States

UC Irvine Medical Center

Orange, California, 92868

United States

Stanford University

Palo Alto, California, 94304

United States

University of California Davis

Sacramento, California, 95817

United States

University of California San Diego

San Diego, California, 92037

United States

University of California San Francisco

San Francisco, California, 94143

United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045

United States

University of Miami

Miami, Florida, 33136

United States

Rush University Medical Center

Chicago, Illinois, 60612

United States

University of Chicago

Chicago, Illinois, 60637

United States

University of Iowa Health Care

Iowa City, Iowa, 52242

United States

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

Wayne State University/Detroit Medical Center Comprehensive Epilepsy Program

Detroit, Michigan, 48201

United States

University of Nebraska

Omaha, Nebraska, 68198

United States

NYU Langone Comprehensive Epilepsy Center

New York, New York, 10016

United States

SUNY Upstate Medical University

Syracuse, New York, 13210

United States

Atrium Health

Charlotte, North Carolina, 28204

United States

Duke University Hospital

Durham, North Carolina, 27710

United States

Atrium Wake Forest Baptist

Winston-Salem, North Carolina, 27157

United States

Oregon Health and Science University

Portland, Oregon, 97239

United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107

United States

UTHealth Houston

Houston, Texas, 77030

United States

University of Utah Health

Salt Lake City, Utah, 84108

United States

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Neurona Therapeutics

John Hixson, MD, STUDY_DIRECTOR, Neurona Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-16

Study Completion Date2042-02

Study Record Updates

Study Start Date2022-06-16

Study Completion Date2042-02

Terms related to this study

Keywords Provided by Researchers

Epilepsy, MTLE, seizure

Additional Relevant MeSH Terms

Mesial Temporal Lobe Epilepsy