AMT-260 Gene Therapy Study in Adults With Unilateral Refractory Mesial Temporal Lobe Epilepsy
Condition(s) studied
Investigational drug(s) / intervention(s)
AAV9-hSyn1-miGRIK2: AMT-260 is an AAV9 gene therapy product that locally delivers miRNA silencing technology to target the GRIK2 gene and suppress aberrantly expressed GluK2 containing kainate receptors. Intervention will be a one-time intracerebral administration of AMT-260.
Study 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).
Eligibility
Primary outcome measure(s)
- To evaluate the safety and tolerability of AMT-260 in adults with unilateral refractory MTLE. — 1 year
Occurrence of Adverse Events during the period of 1 year after AMT-260 administration, including seriousness, severity, and causal relationship to AMT-260.
Trial sites (18)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | Recruiting |
| Mayo Clinic Arizona | Phoenix | Arizona | Recruiting |
| Stanford University | Palo Alto | California | Completed |
| Mayo Clinic Florida | Jacksonville | Florida | Recruiting |
| Kansas University Medical Center | Kansas City | Kansas | Recruiting |
| Johns Hopkins School of Medicine | Baltimore | Maryland | Recruiting |
| Midatlantic Epilepsy and Sleep Center | Bethesda | Maryland | Completed |
| Massachusetts General Hospital | Boston | Massachusetts | Recruiting |
| Corewell Health | Grand Rapids | Michigan | Recruiting |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | Recruiting |
| Northeast Regional Epilepsy Group | Hackensack | New Jersey | Recruiting |
| Robert Wood Johnson Hospital | New Brunswick | New Jersey | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | Recruiting |
| Ohio State University | Columbus | Ohio | Recruiting |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | Recruiting |
| Allegheny Health Network | Pittsburgh | Pennsylvania | Recruiting |
| Baylor Scott & White Medical Center | Austin | Texas | Recruiting |
| Medical College of Wisconsin | Milwaukee | Wisconsin | Recruiting |
More UniQure Biopharma B.V. trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06063850 on ClinicalTrials.gov ↗ ← All trials in the USA