Actively Recruiting
AMT-260 Gene Therapy Study in Adults With Unilateral Refractory Mesial Temporal Lobe Epilepsy
Led by UniQure Biopharma B.V. · Updated on 2026-04-06
12
Participants Needed
18
Research Sites
389 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
AMT-260 Gene Therapy Study in Adults With Unilateral Refractory Mesial Temporal Lobe Epilepsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of unilateral refractory mesial temporal lobe epilepsy
- History of at least 2 documented focal impaired awareness or focal to bilateral tonic-clonic seizures per 30-day period in the 3 months before screening
- Stable type and dose of up to 4 approved anti-seizure drugs for at least 6 months before screening
- Confirmed unilateral hippocampal pathology and matching unilateral seizure focus
- No signs of focal neurocognitive dysfunction inconsistent with disease-related MRI or PET findings
- Women of childbearing potential and fertile men willing and able to use highly effective birth control during the study
- Negative pregnancy test for women of childbearing potential
You will not qualify if you...
- Implanted devices contraindicating MRI or implanted less than 3 months before screening (vagus nerve stimulation devices considered by investigator)
- Any contraindications for general anesthesia or surgery
- Medications that could interfere with clinical or laboratory evaluations or affect safety or ability to comply with procedures
- Seizures with contralateral or extra-temporal onset seen on EEG
- Dementia, progressive neurological disorders, or progressive brain lesions
- Previous major unrelated neurosurgery for tumor, trauma, bleeding, or epilepsy treatment (excluding diagnostic stereo-EEG)
- MRI evidence of epileptogenic extra-temporal lesions or dual temporal lobe pathology
- Inadequate vaccination status including flu and COVID-19 per local guidelines
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-0021
Actively Recruiting
2
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
3
Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
4
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
5
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
6
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21287
Actively Recruiting
7
Midatlantic Epilepsy and Sleep Center
Bethesda, Maryland, United States, 20817
Actively Recruiting
8
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
9
Corewell Health
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
10
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
11
Northeast Regional Epilepsy Group
Hackensack, New Jersey, United States, 07601
Actively Recruiting
12
Robert Wood Johnson Hospital
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
13
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
14
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
15
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
16
Allegheny Health Network
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
17
Baylor Scott & White Medical Center
Austin, Texas, United States, 78735
Actively Recruiting
18
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
U
uniQure
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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