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

RecruitingPhase 1, Phase 2Ages 18 Years - 75 YearsAllUniQure Biopharma B.V.
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Diagnosis of unilateral refractory MTLE * History of seizures with an average of โ‰ฅ 2 documented focal impaired awareness seizures or focal to bilateral tonic-clonic seizures per 30-day period over the 3 month Retrospective Period. * On a stable type and dose regimen of up to a maximum of 4 approved Anti Seizure Drugs for at least 1 month prior to the Retrospective Period. * Confirmed unilateral hippocampal pathology and concordant unilateral seizure focus * No evidence of focal neurocognitive dysfunction, inconsistent with disease pathology- related MRI and/or (18F)FDG-PET findings. * Women of childbearing potential (WOCBP) and fertile male subjects must be willing and able to use highly effective methods of birth control consistently and correctly throughout the study. * For WOCBP only: Negative pregnancy test. Exclusion Criteria: * Implanted devices that would contraindicate MRI; MRI-compatible devices must be implanted โ‰ฅ3 months prior to Screening (vagus nerve stimulation devices will be up to discretion of the Investigator). * Any other contraindications to general anesthesia, surgery, or intra-operative magnetic resonance imaging (MRI). * Medications that could confound clinical (e.g., antipsychotic medication and anti-viral therapy) and laboratory evaluations or could affect a participant's safety or their ability to undergo the neurosurgical procedure or comply with the procedures and study visit schedule. * Bilateral or multifocal epilepsy; or inability to confidently lateralize seizure onset. * Dementia or other progressive neurological disorders and progressive brain lesions. * Previous major disease-unrelated neurosurgical intervention due to intracranial tumor, trauma, or bleeding and/or history of previous intracranial surgery for treatment of epileptic seizures, not including diagnostic stereo-EEG. * MRI evidence of epileptogenic, extra-temporal lesions, or dual temporal lobe pathology. * Status epilepticus within the year prior to Screening.
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What it tests

  • AAV9-hSyn1-miGRIK2
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Where

18 sites
University of Alabama at Birmingham
Birmingham, United States
Mayo Clinic Arizona
Phoenix, United States
Stanford University
Palo Alto, United States
Mayo Clinic Florida
Jacksonville, United States
Kansas University Medical Center
Kansas City, United States
Johns Hopkins School of Medicine
Baltimore, United States
Midatlantic Epilepsy and Sleep Center
Bethesda, United States
Massachusetts General Hospital
Boston, United States

โ€ฆand 10 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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