FREDERICK, MD–(Marketwired – May 30, 2017) – BioElectronics Corporation ( OTC PINK : BIEL ), www.bielcorp.com is pleased to announce the commencement of a clinical study investigating “prevention of migraine” using ActiPatch therapy. Migraine is a debilitating condition that affects more than 36 million Americans, accounting for nearly $36 billion in direct and indirect costs every year in the US alone [1].
Chronic pain is now widely understood to be due to central sensitization, which leads to exaggerated pain perception [2]. Migraine is no exception, since it is well known that sensitization of the trigeminovascular pain pathway can accompany migraine attacks [3]. There is early evidence that ActiPatch can help mitigate this sensitization, so this study is being conducted to determine the efficacy of ActiPatch in preventing chronic migraines.
The study will be a randomized, double-blinded placebo controlled study to investigate the efficacy of ActiPatch in preventing migraine attacks. The study will involve 48 subjects who have been previously diagnosed with migraine. The study is scheduled to take place in two, 4-week periods. The first 4 weeks will serve as a run-in period, during which subjects receive no therapy. After a 1 week break, the subjects will receive either a placebo or active ActiPatch device to use as an intervention for 4 weeks. Each subject will use a standardized migraine diary to record the frequency, duration and severity of their migraine attacks for both 4-week periods. Full details about the study can be found at the NIH’s clinical trials listing page: (https://clinicaltrials.gov/ct2/show/NCT03166046?term=migraine+actipatch&rank=1)
The principal investigator (PI) leading the study is Dr. Barry Eppley, M.D., D.M.D., a plastic surgeon at the Indiana University Health Hospital and clinical professor at the Indiana School of Medicine. Dr. Eppley has years of experience treating migraines, and believes ActiPatch therapy holds promise. He has listed details about the clinical study, along with details on how to apply to be a participant: (http://exploreplasticsurgery.com/bioelectronics-migraine-device-study/)
Sree Koneru, Ph.D., VP of Product Development at BioElectronics and Ian Rawe, Ph.D., Director of Clinical Research at BioElectronics are the co-PI’s and will assist in timely completion of the study. “Migraine is the fastest growing category in the chronic pain market, but existing therapies work poorly. A successful study will help in seeking a non-prescription indication for the prevention of migraines, from the FDA”, Dr. Koneru said.
[1] Migraine Research Foundation. 2017. About Migraine. https://migraineresearchfoundation.org/about-migraine/migraine-facts/.
[2] Woolf, Clifford J. 2011. “Central sensitization: Implications for the diagnosis and treatment of pain.” Pain S2-15.
[3] Bernstein, Carolyn, and Rami Burnstein. 2012. “Sensitization of the Trigeminovascular Pathway: Perspective and Implications to Migraine Pathophysiology.” J Clin Neurol 89-99.
About BioElectronics Corporation
BioElectronics Corporation is a leader in non-invasive electroceuticals and the maker of an industry leading family of disposable, drug-free, pain therapy devices: ActiPatch® Therapy, over-the-counter treatment for back pain and other musculoskeletal complaints; RecoveryRx® Devices for chronic and post-operative wound care; Allay® Menstrual Pain Therapy. For more information, please visit www.bielcorp.com.
Paul Knopick
940-262-3584
pknopick@eandecommunications.com