NeuroPace has announced the completion of the patient enrolment goal in its NAUTILUS pivotal study for the treatment of idiopathic generalised epilepsy (IGE) “more than one quarter ahead of schedule”, according to a company press release.
“We are extremely proud to have completed patient enrolment in our NAUTILUS pivotal study significantly ahead of schedule,” said Martha Morrell, NeuroPace’s chief medical officer. “We would like to recognise and thank the clinical investigators and patients that have enrolled in this important and groundbreaking trial. We believe that the pace of enrolment in the trial highlights the significant unmet need that exists for patients with drug-refractory idiopathic generalised epilepsy.”
NAUTILUS is the “first and only” pivotal clinical study to evaluate neuromodulation therapy in IGE, NeuroPace claims—and, if it is successful, the company’s responsive neurostimulation (RNS) therapy could secure the first device-based indication for generalised epilepsy.
Some 40% of drug-refractory epilepsy patients are diagnosed with generalised epilepsy, and NeuroPace believes that this early patient enrolment milestone is “reflective of the excitement amongst patients and clinicians” in potentially addressing this significant unmet need with the RNS system. According to the company, patients with generalised epilepsy do not need Phase II invasive monitoring and would be able to proceed to RNS system therapy faster, through a non-invasive diagnostic process that could be performed both within and outside of the comprehensive epilepsy centre setting.
The NAUTILUS study—which has received an investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA)—is a prospective, multicentre, single-blind, randomised, sham stimulation-controlled pivotal study designed to demonstrate that the RNS system is safe and effective as an adjunctive therapy for patients aged 12 and older with drug-resistant IGE. The trial requires evaluation of a primary safety endpoint and an effectiveness evaluation at 12 months post-implant.
If NAUTILUS achieves its primary endpoints, NeuroPace plans to submit a premarket approval (PMA) supplement, and also intends to publish findings from the study in a peer-reviewed medical journal.
