NeuroPace NAUTILUS trial: 77% GTC seizure reduction in IGE at AAN 2026 — first ever RCT of neuromodulation in generalized epilepsy
Summary
NeuroPace presented 12- and 18-month data from the NAUTILUS trial — the first randomized controlled trial of neuromodulation in drug-resistant idiopathic generalized epilepsy (IGE) — at the 2026 American Academy of Neurology Annual Meeting. The 18-month data showed 77% median reduction in generalized tonic-clonic seizures in IGE patients on RNS therapy. CMO Martha Morrell: "Approximately 30% of people with idiopathic generalized epilepsy continue to have disabling generalized tonic-clonic seizures despite multiple antiseizure medications, and there are no approved neuromodulation or surgical options for these patients. Seeing a 77% median reduction in GTCs at 18 months of therapy in this refractory population is remarkable. Notably, the 18-month median seizure reduction in the studied IGE population meaningfully exceeds what was observed in our original pivotal focal trial." NeuroPace filed a PMA Supplement to FDA in December 2025 seeking expanded indication for IGE; the application is currently under FDA review.
Why it matters
NAUTILUS's 77% GTC seizure reduction in IGE is a result that is simultaneously statistically and clinically remarkable — not only does it exceed the pivotal focal trial data, it does so in a patient population where no neuromodulation option currently exists. Presenting this at AAN 2026 alongside the PMA Supplement under FDA review creates simultaneous clinical community awareness and regulatory momentum. The neurologist audience at AAN seeing the NAUTILUS data will be the community making referral decisions the moment FDA approves the IGE indication.
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