Trial Profile

A phase 3 randomized, sham-controlled, double-blind study of NRTX-1001 in people living with drug-resistant mesial temporal lobe epilepsy (MTLE)

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 02 Dec 2025

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At a glance

06 Nov 2025 According to Neurona Therapeutics media release, the company announced that the preparations are underway to start screening potential subjects with drug-resistant MTLE for this study.
07 Oct 2025 According to a Neurona Therapeutics media release, data from non-MTS cohort, together with results from ongoing phase 1/2 trials in unilateral and bilateral MTLE and planned phase 3 EPIC study, are intended to support a future BLA submission for NRTX-1001 in drug-resistant MTLE.
07 Oct 2025 According to a Neurona Therapeutics media release, company to provide an update on unilateral and bilateral MTLE programs at the American Epilepsy Society's Annual Meeting in December 2025.

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