NeuroPace’s therapy already gained FDA approval in 2014 for the treatment of adults with partial onset seizures who have not responded to two or more antiepileptic drugs. Image credit: Shutterstock/Andrus Ciprian.

NeuroPace has completed enrolment in a pivotal study investigating its neuromodulation therapy for the treatment of idiopathic generalised epilepsy.

The US-based medtech company said it reached its enrolment goal more than a quarter ahead of schedule. According to the trial’s ClinicalTrials.gov entry, a maximum of 100 participants will be enrolled to ensure at least 80 participants are implanted with the device.

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The prospective, multicenter, single-blind, randomised, sham stimulation controlled pivotal study (NAUTILUS) has enrolled patients aged 12 years and older who have drug-resistant idiopathic generalised epilepsy (IGE).

NeuroPace is using its RNS system as an adjunctive therapy for the reduction of primary generalised seizures in the subject cohort. Approximately 40% of drug-refractory epilepsy patients are diagnosed with generalised epilepsy.

The US Food and Drug Administration (FDA) granted an investigational device exemption (IDE) to NeuroPace in November 2021 to carry out the study. The first patient was implanted in October 2022.

NeuroPace’s chief medical officer Dr Martha Morrell said: “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.”

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According to NeuroPace, it is the first pivotal study to evaluate the use of neuromodulation therapy for treating patients with IGE who have not responded to antiepileptic drugs. There are around 1.2 million drug-refractory epilepsy patients in the US.

IGE constitutes a third of all epilepsies. It is characterised by seizures originating from various parts of the brain at once.

NAUTILUS has a primary safety endpoint and an effectiveness evaluation 12 months post-implant. NeuroPace said the findings will be used to support a premarket approval (PMA) supplement to the FDA.

The company’s RNS system gained FDA approval in 2014 for the treatment of adults with partial-onset seizures who have not responded to two or more antiepileptic drugs. The system is an implantable closed-loop responsive brain stimulation system.

It detects the onset of a seizure by electrodes and delivers small bursts of electrical stimulation to reduce their frequency. NeuroPace says its system monitors, detects and records brain activity, as well as providing therapy.

In March 2020, the system received FDA approval for MRI labelling, allowing patients to receive full-body scans with the implant under appropriate conditions.

A market model by GlobalData estimates the global neuromodulation device market will be worth $11.4bn by 2033.