Mesial Temporal Lobe Epilepsy study: AAV9-hSyn1-miGRIK2
Official title AMT-260 Gene Therapy Study in Adults With Unilateral Refractory Mesial Temporal Lobe Epilepsy
ClinicalTrials.gov ID: NCT06063850
What this study is testing
What is AAV9-hSyn1-miGRIK2?
an investigational gene therapy being studied as a potential treatment for mesial temporal lobe epilepsy is designed to deliver miRNA that silences the GRIK2 gene, reducing abnormal GluK2 kainate receptors in the brain
Also referred to as AMT-260.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out whether AMT-260 is safe, tolerable, and can lower seizure frequency in adults with unilateral mesial temporal lobe epilepsy.
- Who it's for
- Adults who have unilateral mesial temporal lobe epilepsy.
- What's involved
- Participants will receive the AMT-260 gene therapy and undergo regular check‑ups and seizure monitoring during the trial.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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.
You likely can't join if
- Implanted devices that would contraindicate MRI; MRI-compatible devices must be implanted ≥3 months prior to Screening (vagus nerve stimulation...
- 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...
- 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...
See the full eligibility 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 people 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.
- 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...
- 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...
- MRI evidence of epileptogenic, extra-temporal lesions, or dual temporal lobe pathology.
- Status epilepticus within the year prior to Screening.
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Jacksonville, Florida, United States
- Kansas City, Kansas, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Grand Rapids, Michigan, United States
- Lebanon, New Hampshire, United States
- Hackensack, New Jersey, United States
- New Brunswick, New Jersey, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Austin, Texas, United States
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Phoenix, Arizona, United States; Jacksonville, Florida, United States; Kansas City, Kansas, United States; Baltimore, Maryland, United States; Boston, Massachusetts, United States and 10 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.