NeuroSigma, a Los Angeles-based medical device company, has announced conditional approval by the FDA of its IDE application to commence a phase III trial of the Monarch eTNS System for treatment of drug resistant epilepsy. The company is planning to conduct a multi-center trial at medical institutions in the U.S., Europe and Canada. The objective of the study is to evaluate the safety and effectiveness of the device and provide the basis for a Pre-Market Approval (PMA) application to the FDA.
In earlier phase I and phase II clinical trials of external Trigeminal Nerve Stimulation (eTNS), over 40% of patients treated showed a 50% or greater reduction in seizures.
"We believe a safe, non-invasive and affordable alternative to pharmaceuticals and invasive treatments is needed by the 50 million people with epilepsy worldwide," said Leon Ekchian, Ph.D., president and chief executive officer of NeuroSigma.
The Monarch eTNS System is currently available with a physician's prescription in the E.U. and Canada as adjunctive treatment of epilepsy and depression, for adults and children nine years and older.