RecruitingPhase 1Phase 2NCT06063850

AMT-260 Gene Therapy Study in Adults With Unilateral Refractory Mesial Temporal Lobe Epilepsy

A Multi-center, Phase 1/2a, First-in-human (FIH) Study Investigating the Safety, Tolerability, and Efficacy of AMT-260 in Adults With Unilateral Refractory Mesial Temporal Lobe Epilepsy (MTLE) Administered Via Magnetic Resonance Imaging (MRI)-Guided Convection-enhanced Delivery (CED)

Sponsor

UniQure Biopharma B.V.

Enrollment

12 participants

Start Date

Jun 12, 2024

Study Type

INTERVENTIONAL

Conditions

Mesial Temporal Lobe Epilepsy

Summary

The main goals of this clinical study are to learn if AMT-260 is safe and tolerable and works to reduce the frequency of seizures in adults with unilateral mesial temporal lobe epilepsy (MTLE).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a gene therapy called AMT-260, injected directly into the hippocampus area of the brain, to reduce seizures in adults with temporal lobe epilepsy (MTLE) that has not responded to medications. **You may be eligible if...** - You have been diagnosed with drug-resistant mesial temporal lobe epilepsy affecting only one side of the brain - You have at least 2 confirmed seizures per month on average over the past 3 months - You have been on a stable dose of up to 4 anti-seizure medications for at least 6 months and they are still not fully controlling your seizures - Your seizures are confirmed to come from one specific area of the hippocampus on one side of the brain **You may NOT be eligible if...** - Your epilepsy involves both sides of the brain - You have not adequately tried anti-seizure medications first - You have significant cognitive decline in the area targeted by the therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETICAAV9-hSyn1-miGRIK2

AMT-260 is an AAV9 gene therapy product that locally delivers miRNA silencing technology to target the GRIK2 gene and suppress aberrantly expressed GluK2 containing kainate receptors. Intervention will be a one-time intracerebral administration of AMT-260.

Locations(18)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Mayo Clinic Arizona

Phoenix, Arizona, United States

Stanford University

Palo Alto, California, United States

Mayo Clinic Florida

Jacksonville, Florida, United States

Kansas University Medical Center

Kansas City, Kansas, United States

Johns Hopkins School of Medicine

Baltimore, Maryland, United States

Midatlantic Epilepsy and Sleep Center

Bethesda, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Corewell Health

Grand Rapids, Michigan, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Northeast Regional Epilepsy Group

Hackensack, New Jersey, United States

Robert Wood Johnson Hospital

New Brunswick, New Jersey, United States

Cleveland Clinic

Cleveland, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Allegheny Health Network

Pittsburgh, Pennsylvania, United States

Baylor Scott & White Medical Center

Austin, Texas, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06063850

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