LOS ANGELES, Nov. 17, 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, announced today top-line findings from a Phase II dose-ranging study in major depressive disorder (MDD) conducted at the University of California, Los Angeles (UCLA). Funding for the trial was provided by NeuroSigma.
In this dose-ranging trial, external trigeminal nerve stimulation (eTNS) therapy was examined under double-blind conditions as an adjunct to pharmacotherapy for patients with treatment-resistant MDD. The 12-week protocol included an initial six-week dose-ranging phase where subjects received different doses of eTNS or sham therapy. After the initial six weeks, all subjects received the active therapy. The primary endpoint for the trial was the change in depressive symptoms among subjects receiving eTNS versus those receiving sham therapy after the first six weeks.
Forty-three adults with major depressive disorder completed the six-week dose-ranging phase of the trial. Subjects used NeuroSigma's proprietary eTNS therapy to stimulate branches of the trigeminal nerve in the forehead for eight hours each night. Medications remained constant throughout.
Subjects receiving eTNS had significantly greater improvements in symptom severity, as measured by the Beck Depression Inventory (BDI), versus subjects receiving sham therapy (41.7% versus 10.9%, p=0.013). NeuroSigma expects that the UCLA researchers will present more detailed results of the clinical trial at a scientific meeting in 2015.
"We congratulate the UCLA research team for executing this important clinical trial of eTNS in depression. Like the open-label Phase I clinical trial results at UCLA, this dose-ranging study demonstrates a statistically significant improvement in symptom severity, extends this finding under double-blind controlled conditions, and justifies further development of this intervention. As a next step, NeuroSigma is planning to conduct a larger multi-center double-blind clinical trial," said Ian Cook, M.D., Chief Medical Officer at NeuroSigma.
NeuroSigma's Monarch eTNS system is currently approved in the European Union for the adjunctive treatment of major depressive disorder and in Canada for treatment of major depressive disorder, in each case for adults and children nine years and older. 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 epilepsy, depression, post-traumatic stress disorder (PTSD), attention-deficit hyperactivity disorder (ADHD), traumatic brain injury (TBI), 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 and sTNS are investigational devices and are limited by Federal law to investigational use. The U.S. Food and Drug Administration (FDA) has given NeuroSigma approval to proceed with a pivotal Phase III clinical trial of external TNS (eTNS) in drug-resistant epilepsy. Completion of that Phase III trial is necessary before the FDA will consider permitting the marketing and sale of eTNS in the United States.
eTNS, sTNS, 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, PTSD, ADHD, and TBI. 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.
SOURCE NeuroSigma, Inc.