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RecruitingPhase 1 / Phase 2

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will be monitored through study site visits, telephone calls, blood tests, and questionnaires about how their seizures affect daily life."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests AMT-260 gene therapy in adults with hard-to-treat epilepsy that starts deep in one side of the brain’s temporal lobe. It aims to learn if the treatment is safe, how well people tolerate it, and whether it reduces seizures.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have hard-to-treat mesial temporal lobe epilepsy (MTLE) on one side of the brain.
  • Have records showing an average of at least 2 qualifying seizures every 30 days during the 3-month review period. These seizures must reduce awareness or spread to both sides of the brain and cause stiffening and shaking.
  • Take no more than 4 approved seizure medicines, with the same types and doses for at least 1 month before the review period.
  • Have confirmed damage or changes in the hippocampus, a brain area involved in memory, on the same side where seizures start.
  • Have no problems with thinking or memory in a specific brain area that do not fit the disease-related MRI or PET scan findings.
  • If able to become pregnant or father a child, be willing and able to use highly effective birth control correctly throughout the study.
  • If able to become pregnant, have a negative pregnancy test.

Who can't join

  • Have an implanted device that is unsafe for MRI scans. MRI-safe devices must have been placed at least 3 months before screening; the study doctor decides about vagus nerve stimulators.
  • Cannot safely have surgery, general anesthesia (medicine that keeps you asleep during surgery), or an MRI during surgery.
  • Take medicines that could affect study tests, safety, brain surgery, or the ability to follow study steps and visits. Examples include antipsychotic and antiviral medicines.
  • Have epilepsy starting on both sides or in several brain areas, or the side where seizures start cannot be clearly identified.
  • Have dementia, another worsening brain or nerve disease, or worsening areas of brain damage.
  • Have had major brain surgery for a tumor, injury, or bleeding unrelated to epilepsy, or surgery to treat seizures. Diagnostic stereo-EEG testing does not count.
  • Have MRI findings showing seizure-causing changes outside the temporal lobe or two types of abnormal changes in the temporal lobe.
  • Have had status epilepticus—long-lasting seizures or repeated seizures without recovery between them—within the year before screening.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Diagnosis of unilateral refractory MTLE * History of seizures with an average of ≥ 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 ≥3 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.

Study sites (18)

AL

AZ

CA

FL

KS

MA

MD

MI

NH

NJ

OH

PA

TX

WI