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RecruitingPhase 1/Phase 2

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

UniQure Biopharma B.V. · NCT06063850

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–75 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1, Phase 2
Target enrollment
12
US sites recruiting
16
Study start
June 12, 2024
Record last updated
August 24, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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).

Being studied: AAV9-hSyn1-miGRIK2

Conditions: Mesial Temporal Lobe Epilepsy

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • University of Alabama at Birmingham

    Birmingham, AL 35294-0021

    Site contact: Jennifer Pilkington · 205-934-8352 · jlpilkington@uabmc.edu

  • Mayo Clinic Arizona

    Phoenix, AZ 85054

    Site contact: Jonathon Parker, MD · 480-342-2906 · Parker.Jonathon@mayo.edu

  • Mayo Clinic Florida

    Jacksonville, FL 32224

    Site contact: Megan J Gauthier · 904-953-2000 · Gauthier.Megan2@mayo.edu

  • Kansas University Medical Center

    Kansas City, KS 66160

    Site contact: Laura Crabtree · 913-574-0412 · lcrabtree2@kumc.edu

  • Johns Hopkins School of Medicine

    Baltimore, MD 21287

    Site contact: Joon Kang, MD · 410-955-2822 · Jkang50@jh.edu

  • Massachusetts General Hospital

    Boston, MA 02114

    Site contact: Erin Donahue · 617.643.3732 · ekdonahue@mgh.harvard.edu

  • Corewell Health

    Grand Rapids, MI 49503

    Site contact: David Burdette, MD · (616) 267-0301 · david.burdette@corewellhealth.org

  • Dartmouth Hitchcock Medical Center

    Lebanon, NH 03756

    Site contact: Anastasia Kanishcheva, MPH, CCRC · 603-650-0260 · Anastasia.Kanishcheva@Hitchcock.ORG

  • Northeast Regional Epilepsy Group

    Hackensack, NJ 07601

    Site contact: Hardik Rana · 551-497-5000 · hrana@epilepsygroup.com

  • Robert Wood Johnson Hospital

    New Brunswick, NJ 08901

    Site contact: Christine Yohn · 908-328-4210 · cy253@rwjms.rutgers.edu

  • Cleveland Clinic

    Cleveland, OH 44195

    Site contact: Xiaoming Zhang · 216-445-7510 · zhangx6@ccf.org

  • Ohio State University

    Columbus, OH 43210

    Site contact: James Elder, MD · 614-685-1965 · james.elder@osumc.edu

  • Hospital of the University of Pennsylvania

    Philadelphia, PA 19104

    Site contact: Melissa Johnston Esparza, MS · 215-614-0520 · melissa.johnstonesparza@pennmedicine.upenn.edu

  • Allegheny Health Network

    Pittsburgh, PA 15212

    Site contact: Sarah Kimutis · 412-359-3565 · sarah.kimutis@ahn.org

  • Baylor Scott & White Medical Center

    Austin, TX 78735

    Site contact: Victor H Gonzalez Montoya · 512-654-1234 · Victor.gonzalezmontoya@bswhealth.org

  • Medical College of Wisconsin

    Milwaukee, WI 53226

    Site contact: Sarah Young · 414-955-0989 · scyoung@mcw.edu

Study contacts (from the official record)

  • uniQure · 1-866-520-1257 · medinfo@uniqure.com
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AMT-260 Gene Therapy Study in Adults With Unilateral Refractory… (NCT06063850) | Bored Studies