Why did NeuroPace's trial in generalized epilepsy measure tonic-clonic seizures above all? · Grey Matter
Generalized tonic-clonic seizures are the ones that injure people, and their frequency is the strongest known risk factor for sudden unexpected death in epilepsy.
Why did NeuroPace's trial in generalized epilepsy measure tonic-clonic seizures above all?
Generalized tonic-clonic seizures are the ones that injure people, and their frequency is the strongest known risk factor for sudden unexpected death in epilepsy. The NAUTILUS trial therefore took as its primary endpoint the time until a second such seizure, and on that measure stimulation did not beat sham. Counted over 18 months instead, the same seizures fell by a median of 77 % and 40 % of participants had none, which is the evidence the company has put before the US regulator, who asked for more.