AMT-260 Gene Therapy Study in Adults With Unilateral Refractory Mesial Temporal Lobe Epilepsy
Start Date
6/12/2024
Completion Date
12/1/2031
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).
Detailed Description
In this first clinical study of AMT-260, two dose levels will be studied to find the best dose of AMT-260. All eligible participants will receive AMT-260 at one of the two dose levels (i.e., there is no placebo in this study). AMT-260 is intended for a one-time administration, without the need to remove or destroy any part of the brain. Participation in this study would not prevent later pursuit of other treatment options. Participants will be monitored through study site visits, telephone calls, blood tests, and questionnaires about how their seizures affect daily life. Participants will record seizures using an electronic seizure diary.
Eligibility Criteria
Age Range: 18 years to 75 years
Interventions
AAV9-hSyn1-miGRIK2
Conditions
Locations
University of Alabama at Birmingham
Birmingham, Alabama 35294-0021
United States
Mayo Clinic Arizona
Phoenix, Arizona 85054
United States
Stanford University
Palo Alto, California 94304
United States
Mayo Clinic Florida
Jacksonville, Florida 32224
United States
Kansas University Medical Center
Kansas City, Kansas 66160
United States
Johns Hopkins School of Medicine
Baltimore, Maryland 21287
United States
Midatlantic Epilepsy and Sleep Center
Bethesda, Maryland 20817
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Corewell Health
Grand Rapids, Michigan 49503
United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03756
United States
Northeast Regional Epilepsy Group
Hackensack, New Jersey 07601
United States
Robert Wood Johnson Hospital
New Brunswick, New Jersey 08901
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
Ohio State University
Columbus, Ohio 43210
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Allegheny Health Network
Pittsburgh, Pennsylvania 15212
United States
Baylor Scott & White Medical Center
Austin, Texas 78735
United States
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States