In the current issue
A Positive Signal With a Negative Primary Endpoint: The NAUTILUS Trial.
This monthly special is a journal-club reading of NAUTILUS, the randomized sham-controlled trial of responsive centromedian thalamic stimulation for drug-resistant idiopathic generalized epilepsy with recurrent generalized tonic-clonic seizures.
The episode's main point is endpoint discipline: the primary safety endpoint was met, the prespecified primary effectiveness endpoint was not statistically significant, and the longer-term and post hoc signals remain clinically important but bounded.
In this issue5 topics
- NAUTILUS is an encouraging signal, not a simple positive trial.
- The prespecified primary effectiveness endpoint was not statistically significant.
- Post hoc and 18-month seizure outcomes matter clinically but cannot erase the endpoint hierarchy.
- Centromedian thalamic RNS belongs in careful counseling and referral discussions for selected drug-resistant IGE patients with recurrent GTCS.
- The trial does not establish thalamic RNS as standard-of-care therapy for IGE.