Primary and secondary endpoints statistically significant
LOS ANGELES, Oct. 30, 2017 /PRNewswire/ -- NeuroSigma, Inc. (NeuroSigma) today announced that on Friday, October 27, 2017, at the Annual Meeting of the American Academy of Child and Adolescent Psychiatry (AACAP), James McGough, M.D., M.S., presented the results of a double-blind randomized controlled trial of external Trigeminal Nerve Stimulation (eTNS®) for treating pediatric Attention Deficit Hyperactivity Disorder (ADHD). Dr. McGough, Professor of Clinical Psychiatry at the Semel Institute for Neuroscience and Human Behavior (Semel Institute) and David Geffen School of Medicine at the University of California, Los Angeles (UCLA), was the Principal Investigator for the trial. Sandra Loo, Ph.D., Associate Professor at the Semel Institute and David Geffen School of Medicine at UCLA, was the Co-Principal Investigator.
The trial investigated the effects of eTNS on ADHD as the sole treatment, or "monotherapy." A total of 62 children were enrolled in the trial and used the eTNS therapy each night, at home, for four weeks. The trial's primary endpoint assessment, the ADHD-RS, showed that subjects randomized to active treatment had a statistically significant improvement in their ADHD symptoms compared with the sham group (p = 0.005). The CGI-I scale, a secondary endpoint, also demonstrated statistically significant improvements in ADHD symptoms among subjects randomized to the treatment group (p = 0.003). Side effects were generally mild and transient.
The U.S. National Institute of Mental Health (NIMH) provided independent grant funding to support this double-blind randomized controlled trial of eTNS for treating children with ADHD, ages 8 to 12. NeuroSigma provided the eTNS systems for the trial.
The scientific basis for this double-blind trial was established by an earlier open label trial conducted at UCLA, with funding and eTNS systems provided by NeuroSigma. In that trial, Dr. McGough and his team found significant improvements in the symptoms of ADHD and cognition in children treated with eTNS. A report of the trial in the journal Brain Stimulation summarized the results on 24 youths, ages 7 to 14, who had enrolled in an eight-week open trial of eTNS administered nightly during sleep. Significant improvements were seen on the ADHD-RS (p < 0.0001) and the parent-completed Conner's Global Index (p < 0.0001) compared to baseline. Improvements were also noted on computerized tests of cognition.
"ADHD is estimated to affect 9.5% of school age children and 4.4% of adults, and our current treatments primarily include psychostimulant medications and behavioral therapies. While there is great demand for non-medication approaches to ADHD, most popular alternatives are not linked to any mechanistic understanding of brain processes and similarly lack significant scientific evidence to support their use. I am excited to have found a significant improvement in ADHD symptoms in our double-blind randomized clinical trial of this neuromodulation treatment," said Dr. McGough. "In both our open label and double-blind trials, TNS was well accepted by patients and families, treatment compliance was high, and there were no clinically meaningful side effects or adverse events."
"We congratulate Drs. McGough and Loo and their team for completing this important clinical trial. Using rigorous, state-of-the-art methods, they found a clear superiority in the use of active eTNS over sham treatment. Their findings advance the evidence that eTNS addresses both the cognitive and behavioral aspects of ADHD, which is an exciting development in the neuromodulation field," said Ian Cook, M.D., Chief Medical Officer at NeuroSigma.
"The core value proposition of eTNS is effective non-pharmacological treatment with minimal side-effects. We are very pleased with the results of this double-blind trial and applaud the dedication and efforts of the UCLA team. Following FDA approval, we look forward to offering parents a non-pharmacological treatment option for pediatric ADHD in the United States," said Leon Ekchian, Ph.D., President and CEO of NeuroSigma.
NeuroSigma is a California-based life sciences company focused on commercialization of its non-invasive eTNS technology for the treatment of neuropsychiatric and neurological disorders. The Monarch eTNS System® has received CE mark approval in the European Union for ADHD for children age 7 and older and as adjunctive therapy for depression and epilepsy, as well as regulatory approvals in Canada and Australia.
CAUTION: In the United States, eTNS is an investigational device and is limited by Federal law to investigational use.
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 directly or indirectly to specific areas of the brain, such as the locus coeruleus, nucleus tractus solitarius, thalamus, and the cerebral cortex, which are involved in ADHD, depression, post-traumatic stress disorder (PTSD), epilepsy and other disorders.
Trigeminal Nerve Stimulation (TNS) is the electrical stimulation of branches of the trigeminal nerve, including those 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.
eTNS, Monarch, and Monarch eTNS are trademarks of NeuroSigma, Inc.
About NeuroSigma, Inc.
NeuroSigma is a California-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 exclusively licensed from UCLA, including TNS therapies for ADHD, depression, PTSD and epilepsy. For more information about NeuroSigma, please visit www.neurosigma.com and www.monarch-etns.com .
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; failing to obtain FDA approval; and governmental laws and regulations affecting domestic and foreign operations. We do not undertake any obligation to update or revise the forward-looking statements to reflect events or circumstances that exist after the date on which such statements were made, except to the extent required by law.