August 4, 2011
NeuroSigma Responds to Substantial Interest Generated by NPR Story on Promising Epilepsy Clinical Trial
LOS ANGELES, Aug. 4, 2011 /PRNewswire/ -- NeuroSigma, Inc., a Los Angeles-based medical device company, today provided an update in response to substantial interest and inquiries generated by a National Public Radio (NPR) news story which aired July 27, 2011 on the use of non-invasive Trigeminal Nerve Stimulation (TNS) for the treatment of drug-resistant epilepsy.
NeuroSigma is now planning a Phase III pivotal trial for its external TNS (eTNS(TM)) system. Earlier this year, Dr. DeGiorgio delivered results of the 50-subject Phase II double-blind clinical trial to the Antiepileptic Drug Trials XI Conference in Miami, Florida. The results compared favorably with those of pharmaceuticals and surgically-implanted devices. (http://www.prnewswire.com/news-releases/positive-results-reported-for-phase-ii-randomized-double-blind-clinical-trial-for-the-treatment-of-drug-resistant-epilepsy-using-external-trigeminal-nerve-stimulation-etns---the-usb-port-to-the-brain-120917294.html)
The study found that subjects receiving NeuroSigma's active eTNS(TM) treatment experienced a significant improvement in seizure reduction, while those randomized to receive the control condition ("sham" or "placebo") did not. Subjects receiving active treatment showed a 40% responder rate after 18 weeks of daily stimulation compared to a 15% responder rate in the placebo group. A responder is defined as someone who experiences a greater than 50% reduction in seizures. In addition to reducing seizures, eTNS(TM) also improved mood. These results confirm and extend the findings of DeGiorgio's positive feasibility trial in epilepsy, reported in 2009 in the journal, Neurology.
At the same conference, DeGiorgio also revealed a potential mechanism of action for the eTNS(TM) treatment of epilepsy. Using Positron Emission Tomography (PET), significant decreases in regional cerebral blood flow were detected in several regions of the cerebral cortex, which is where seizures originate.
NeuroSigma is currently developing its next generation eTNS(TM) system and in 2012 anticipates filing a CE Mark application for approval to commence marketing its new eTNS(TM) system for the treatment of epilepsy in Europe.
In addition, in 2012, the company anticipates filing an IDE for an upcoming multi-center Phase III pivotal trial in the United States. Neither NeuroSigma nor UCLA are currently enrolling subjects for eTNS(TM) epilepsy trials.
Future updates regarding clinical trials, including potential enrollment details, and study results will be posted on NeuroSigma's website (www.neurosigma.com).
CAUTION: The eTNS(TM) system is an investigational device and at this time is limited by United States law for investigational use only in approved research protocols. NeuroSigma does not recommend the off-label use of nerve or muscle electrical stimulation units for any purpose not approved by the FDA because of the potential risk of injury or death.
About NeuroSigma, Inc.
NeuroSigma is a Los Angeles-based medical technology company established to in-license and develop early stage technologies with the potential to transform medical practice. Currently NeuroSigma has a specific focus on neuromodulation and through a majority-owned subsidiary, NSVascular, on Thin-Film Nitinol covered stents for endovascular applications. NeuroSigma employs two therapy platforms: Trigeminal Nerve Stimulation (TNS) and Deep Brain Stimulation (DBS). NeuroSigma has amassed significant intellectual property licensed on an exclusive basis from the University of California, Los Angeles (UCLA), including potential therapies for epilepsy, depression and post-traumatic stress disorder (PTSD) via TNS and for PTSD, obesity and cachexia via DBS. For more information about NeuroSigma, visit their website at http://www.neurosigma.com.
SOURCE NeuroSigma, Inc.