NIH Funds Phase 2 Clinical Trial at UCLA for the Treatment of ADHD with NeuroSigma's eTNS System

LOS ANGELES, July 9, 2014 /PRNewswire/ -- NeuroSigma, Inc. (NeuroSigma), a California-based life sciences company focused on commercialization of its non-invasive Monarch™ eTNS™ System for the treatment of neurological and neuropsychiatric disorders, today announced that the U.S. National Institutes of Health (NIH) has awarded UCLA a grant that funds a Phase II 90-subject pediatric clinical trial at the University of California, Los Angeles (UCLA) focused on the treatment of Attention Deficit Hyperactivity Disorder (ADHD) with NeuroSigma's external trigeminal nerve stimulation (eTNS) System.

James McGough, M.D., Professor of Psychiatry and Biobehavioral Sciences at UCLA, will lead the study as Principal Investigator, with Sandra Loo, Ph.D., Associate Professor, as Co-Principal Investigator.  Their earlier Phase I trial of eTNS for the treatment of ADHD, funded by NeuroSigma, found significant improvements in the severity of ADHD symptoms with eight weeks of nightly eTNS therapy.  This Phase II clinical trial will evaluate eTNS as monotherapy, under double-blind conditions, in up to 90 children, ages eight to 12, in a four week randomized clinical trial conducted at UCLA.  NeuroSigma will provide eTNS systems to UCLA in support of the trial.  Neither Dr. McGough nor Dr. Loo has any affiliation with NeuroSigma.

ADHD usually arises in childhood.  The U.S. Centers for Disease Control and Prevention (CDC) has reported national survey findings that approximately 11 percent of children ages four to 17 have been diagnosed with the disorder, and that about one in five high school boys will receive this diagnosis during childhood.  Symptoms include difficulty paying attention in school, at play, or in the home, a reluctance to take on tasks that require sustained mental effort, being easily distracted, exhibiting physical hyperactivity, and engaging in impulsive behaviors.  These symptoms may interfere with social, school, or work functioning.

"I am very pleased that the NIH has funded this extremely important Phase II clinical trial in ADHD.  Millions of parents seek alternatives to drug treatment for their children with ADHD that are safe and non-invasive," said Leon Ekchian, Ph.D., NeuroSigma's President and CEO. 

"Dr. McGough and Dr. Loo are to be congratulated for receiving this grant, particularly at a time when the NIH budget is under pressure to fund only the most promising lines of investigation. NIH awards represent one of the most stringent forms of peer review in biomedical science," noted Ian Cook, M.D, NeuroSigma's Chief Medical Officer and Senior Vice President.  "Besides showing safety of eTNS in children, their Phase I study found a significant impact on the clinical symptoms of ADHD, and substantial improvements on sleep as well as several objective computer-based measures of cognitive performance.  We look forward to confirming these results in this Phase II clinical trial under double-blind controlled conditions. A neuromodulation treatment option for ADHD could avoid concerns about the exposure of children to the psychostimulant medications that are the current first-line treatments." 

Background – The Monarch eTNS System from NeuroSigma

In August 2012, NeuroSigma received CE Mark approval to market NeuroSigma's first trigeminal nerve stimulation (TNS) product, the Monarch™ eTNS™ System, in the European Union, for the adjunctive treatment of epilepsy and major depressive disorder (MDD) for adults and children nine years and older. In addition, the Monarch™ eTNS™ System also received a Class II medical device license from Health Canada in April of 2013 allowing NeuroSigma to market the system for treatment of drug-resistant epilepsy (DRE) and MDD for adults and children nine years and older.  In April of 2014, NeuroSigma received approval from the Australian Therapeutic Goods Administration (TGA) to market the system in Australia for the adjunctive treatment of DRE in adults and children nine years and older. NeuroSigma is currently offering the Monarch™ eTNS™ System to patients in these jurisdictions with a physician's prescription.

The Monarch™ eTNS™ System is composed of a cell-phone sized pulse generator and a single-use patch that is applied to the forehead.  Signals are transmitted through lead wires to the patch in order to stimulate the trigeminal nerve in the skin of the forehead; triggering these nerve fibers sends signals to targeted brain regions and changes the activity there.  Patients may conveniently self-administer the Monarch™ eTNS™ System at home and typically use the device while sleeping.

Background – TNS

The trigeminal nerve is the largest cranial nerve, offering a high-bandwidth pathway for signals to enter the brain, bilaterally and at high frequency. The trigeminal nerve projects to specific areas of the brain, such as the locus coeruleus, nucleus tractus solitarius, thalamus, and the cerebral cortex, which are involved in epilepsy, depression, PTSD, ADHD, and other disorders. 

Trigeminal Nerve Stimulation (TNS) is the electrical stimulation of branches of the trigeminal nerve, which are located near the surface of the forehead.  Functional neuroimaging data suggests the mechanism of action of TNS is related to its ability to modulate activity in targeted brain regions.

CAUTION: In the United States, eTNS™ is an investigational device and is limited by Federal law to investigational use.  The U.S. Food and Drug Administration has given NeuroSigma approval to proceed with a pivotal Phase III clinical trial of eTNS in drug-resistant epilepsy. Completion of that Phase III study is necessary before the FDA will consider permitting the marketing and sale of eTNS in the United States.

eTNS, Monarch, and Monarch eTNS are trademarks of NeuroSigma, Inc.

About NeuroSigma, Inc.

NeuroSigma is a Los Angeles-based life sciences company established to develop bioelectronic technologies with the potential to transform medical practice and patients' lives.  NeuroSigma is focused on TNS neuromodulation therapies based on intellectual property licensed on an exclusive basis from the University of California, Los Angeles (UCLA), including TNS therapies for epilepsy, depression, post-traumatic stress disorder (PTSD) and attention-deficit hyperactivity disorder (ADHD). For more information about NeuroSigma, please visit www.neurosigma.com.

Forward-Looking Safe Harbor Statement

This press release contains forward-looking statements, including but not limited to, research and development outcomes, efficacy, adverse reactions, market and product potential, product availability and other statements regarding our eTNS™ system.  These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company's expectations and projections. Risks and uncertainties include, among other things, general industry and medical device market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to new product marketing, such as the unpredictability of market acceptance for new medical device products; inconsistency of treatment results among patients; potential difficulties in manufacturing a new product; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations.

Website:         http://www.neurosigma.com  
                      http://www.Monarch-eTNS.com

SOURCE NeuroSigma, Inc.