Status:
RECRUITING
AMT-260 Gene Therapy Study in Adults With Unilateral Refractory Mesial Temporal Lobe Epilepsy
Lead Sponsor:
UniQure Biopharma B.V.
Conditions:
Mesial Temporal Lobe Epilepsy
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
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).
Detailed Description
In this first clinical study of AMT-260, two dose levels will be studied to find the best dose of AMT-260. All eligible participants will receive AMT-260 at one of the two dose levels (i.e., there is ...
Eligibility Criteria
Inclusion
- 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 in the 3 months prior to screening.
- On a stable type and dose regimen of up to a maximum of 4 approved Anti Seizure Drugs for at least 6 months prior to screening.
- 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
- 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 for generalized anesthesia or surgery.
- 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.
- Any seizures with contralateral or extra-temporal icta onset captured on EEG.
- 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.
- Magnetic resonance imaging evidence of epileptogenic, extra-temporal lesions, or dual temporal lobe pathology.
- Inadequate vaccination status (including flu shots and other relevant immunizations such as COVID-19 per local guidelines and regulations).
Key Trial Info
Start Date :
June 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2031
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06063850
Start Date
June 12 2024
End Date
December 1 2031
Last Update
December 10 2025
Active Locations (18)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-0021
2
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
3
Stanford University
Palo Alto, California, United States, 94304
4
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224