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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)

Trial Profile

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)

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 03 Jun 2025

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At a glance

  • Drugs AMT 260 (Primary)
  • Indications Temporal-lobe-epilepsy
  • Focus Adverse reactions; First in man; Proof of concept
  • Acronyms GenTLE
  • Sponsors uniQure

Most Recent Events

  • 29 May 2025 According to an uniQure media release, the study is actively screening additional patients throughout 12 sites, with additional sites expected to be activated by the end of 2025.
  • 29 May 2025 Results presented in the uniQure Media Release.
  • 29 May 2025 According to an uniQure media release, company announced the presentation of a clinical case study of the first participant dosed in the first cohort of this trial at the Epilepsy Therapies & Diagnostics Development Symposium in Leesburg, Virginia.

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