Positive Results Reported for Phase I Clinical Trial at UCLA for the Treatment of ADHD in Children Using External Trigeminal Nerve Stimulation (eTNS) Symptom improvements in-line with effects reported with stimulant drugs
LOS ANGELES, May 20, 2013 /PRNewswire/ -- Today, at the American Psychiatric Association (APA) Meeting in San Francisco, James McGough, M.D., M.S., principal investigator and Professor of Clinical Psychiatry at the Semel Institute for Neuroscience and Human Behavior and David Geffen School of Medicine at the University of California Los Angeles (UCLA), and director of clinical teaching programs in both Child and Adolescent Psychopharmacology and ADHD at UCLA, presented the results of a Phase I open-label pediatric clinical trial. The study commenced in November 2011 and investigated the effects of external Trigeminal Nerve Stimulation (eTNS™) on Attention Deficit Hyperactivity Disorder (ADHD) as stand-alone monotherapy (i.e., without use of medications of any kind).
Mean improvements of over 40% were recorded after 4 weeks and over 45% after 8 weeks (both results p<0.001 versus baseline) using the total scores of the a priori primary outcome metric, the clinician-rated ADHD Rating Scale (ADHD-RS). These results are in line with improvements reported in other clinical trials that used stimulant medications, and form the basis for proceeding with larger clinical trials under double blind conditions to better establish its effects. In the eTNS trial, 20 subjects, aged 7 to 14 years with APA Diagnostic and Statistical Manual-IV (DSM-IV) diagnosis of ADHD, had stimulating electric patch electrodes placed on their foreheads on a nightly basis while asleep. Their ADHD symptoms were assessed every four weeks. eTNS was well tolerated and no serious adverse events occurred during the 8-week treatment period.
The investigator-initiated study was funded entirely by NeuroSigma and conducted at UCLA. Project design, data collection, analyses, and conclusions, were solely the work of the UCLA study investigators.
"I am very encouraged by the results of this 20 subject open-label study. The treatment is safe, well received by children and adolescents with ADHD, and has suggested potential as a non-medication ADHD therapy. The results of the study warrant moving forward with a larger double-blind Phase II clinical trial. I would like to thank members of my team for their hard work and NeuroSigma for supporting this study," said Dr. McGough.
"PET imaging studies we had conducted in humans showed immediate effects of eTNS on activity in centers in the brain associated with attention," said Ian Cook, M.D., Director of the UCLA Depression Research & Clinic Program and Chief Medical Advisor to NeuroSigma. "These observations served as an initial road map for a likely mechanism of action for eTNS on ADHD, and we are very encouraged that the results of Dr. McGough's study showed robust clinical effects. As has been the case with eTNS trials to date in epilepsy, depression and PTSD, the participants in this study told us that the eTNS device was easy to use at home and there were no significant adverse events related to use of the system.
"These results not only demonstrate that the eTNS system has the potential to provide parents with a non-drug option to manage their children's ADHD and relieve them of worries about their child's use of stimulants, but also provide encouraging data for pediatricians, child psychologists and child psychiatrists who worry about drug side effects and who have concerns about how stimulant drugs may be abused outside the clinical setting," said Dr. Cook.
"We would like to applaud the hard work of Dr. McGough and his clinical team at UCLA for this important work and look forward to continuing to support their activities in the future," added Lodwrick Cook, Chairman of NeuroSigma.
"ADHD is a very high priority indication for NeuroSigma. We are committed to making this non-stimulant potential treatment for ADHD affordable and available worldwide as soon as possible," said Leon Ekchian, Ph.D., President & CEO of NeuroSigma.
Background - TNS
The trigeminal nerve is the largest cranial nerve, offering a high-bandwidth pathway for signals to enter the brain. 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 very close to the surface of the skin in the forehead. The low-energy stimulus is confined to the soft tissues of the forehead without direct penetration into the brain. PET imaging studies in humans confirm that eTNS activates or inhibits key regions implicated in these disorders and the changes were observed within minutes of therapy.
NeuroSigma's first TNS product, the Monarch™ eTNS™ System, is currently being marketed to patients in the European Union (EU), with a physician's prescription. In September 2012, NeuroSigma received CE Mark approval for the adjunctive treatment of epilepsy and major depressive disorder, for adults and children 9 years and older in the EU and last month received a Class 2 medical device license from Health Canada covering the use of the system in adults and children 9 years and older for treatment of drug-resistant epilepsy (DRE), major depressive disorder (MDD), and treatment-resistant depression.
The Monarch consists of a small stimulator that can be placed in a pocket or worn at the waist, and an electric patch that is placed on the forehead. The patch stimulates the trigeminal nerve through the surface of the skin, and is used primarily while the patient is asleep.
NeuroSigma is the exclusive worldwide licensee of UCLA's entire TNS intellectual property portfolio and continues to develop additional technologies and target additional indications.
CAUTION: In the United States, both eTNS™ and sTNS™ are investigational devices and are limited by Federal (or United States) law to investigational use.
eTNS, sTNS, Monarch, and the Monarch eTNS are trademarks of NeuroSigma, Inc.
About NeuroSigma, Inc.
NeuroSigma is a Los Angeles-based medical device company established to develop early stage technologies with the potential to transform medical practice and patients' lives. Currently, NeuroSigma is focused on neuromodulation therapies and has amassed significant 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™ and sTNS™ systems. 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.