NeuroSigma has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to begin a Phase III pivotal trial of its Monarch eTNS System.
Designed to treat the drug resistant epilepsy, the Monarch system consists of an external electric pulse generator and an electric patch, which is attached to a patient’s forehead to safely stimulate branches of the trigeminal nerve through the skin.
Currently, the company is planning to conduct a multi-center trial in the US, Europe and Canada.
This trial will evaluate the safety and effectiveness of the device and provide the basis for a pre-market approval.
In earlier Phase I and Phase II clinical trials of eTNS, about 40% of patients showed a 50% or greater reduction in seizures with epilepsy and reduced symptom severity in patients with depression, PTSD and ADHD.
NeuroSigma president and CEO Dr Leon Ekchian noted the firm is ready to take next key step in the regulatory approval process of eTNS in the US.
"We believe a safe, non-invasive and affordable alternative to pharmaceuticals and invasive treatments is urgently needed by the 50-million people with epilepsy worldwide," Dr Ekchian added.
The system is currently available with a physician’s prescription in the EU and Canada as adjunctive treatment of epilepsy and depression for adults and children above eight years.