A randomized, placebo-controlled study published in Pain Management evaluated the preventive efficacy of the non-pharmacological device after two weeks of use
NETANYA, Israel and BRIDGEWATER, N.J., Sept. 13, 2023 /PRNewswire/ — Theranica, a neuromodulation therapies company, has announced the results of a study recently published in Pain Management, suggesting the rapid impact of Nerivio, the first and the only neuroband for migraine, in reducing the number of migraine days.
A previous study already showed that the use of Nerivio every other day for 8 weeks reduces the average number of migraine days per month by 4.0 days (vs. 1.3 days in the placebo group, p < 0.001). The study (NCT04828707) was a prospective, randomized, double-blind, placebo-controlled clinical trial that evaluated the efficacy of REN treatment applied every other day for the prevention of migraine. The trial included a 4-week baseline (observation) phase and an 8-week double-blind intervention phase. The number of monthly migraine days (MMD) per group was calculated at two-week intervals and compared between groups (95 subjects in the Nerivio group and 84 in the placebo group).
The new study was a post-hoc analysis of that study, evaluating preventive response at time points prior to 8 weeks. The results were that, after two weeks of use, there was a statistically significant average reduction of 1.7 migraine days per month, compared to 0.8 days in the placebo group (p=0.036), and after 4 weeks of use a reduction of 3.1 days (vs. 1.5 days in placebo, p=0.025).
Preventive treatment is key to managing and mitigating the burden of migraine. A key challenge in migraine treatment is that many preventive medications take a relatively long time to work, with some taking several months. This can make it difficult to treat migraine sufferers, especially teenagers. This new publication suggests a rapid and sustained reduction in monthly migraine days when using Nerivio on alternate days.
“These results suggest that the preventive effect of REN begins quite soon after starting to take it every other day,” explained Andrea Harriott, a neurologist at Massachusetts General Hospital and an associate professor at Harvard Medical School, who is one of the authors. of the new study. “This study demonstrates that Nerivio responds to patient preferences by providing a rapid onset of action, along with high efficacy and a low incidence of side effects.”
In another study, published earlier this year in Headache, migraine sufferers were asked to rate the factors that mattered most to them in being satisfied with their migraine preventive treatment. Efficacy and speed of appearance were the best valued factors. Other studies have also obtained similar results, showing that people who suffer from migraine value treatments that start acting quickly.
“For medical solutions to have true patient-centered meaning, you have to be very attentive and committed to understanding the patient’s needs and be open to creating unusual therapies for the treatment of migraine,” highlighted Alon Ironi, CEO and co-founder of Theranica. “Migraine is an extremely debilitating disease. People living with migraine need fast results to be able to continue their normal activities, which is why we are so excited about this latest prevention data. This further demonstrates the important clinical benefits that Nerivio offers to adults and adolescents who suffer from this neurological disorder.
Controlled by a smartphone app and self-administered, Nerivio wraps around the upper arm and uses sub-painful Remote Electrical Neuromodulation (REN) to activate nociceptive nerve fibers in the arm to send signals that trigger a pain management mechanism. descending pain in the brain called conditioned pain modulation (CPM), which turns off migraine pain and associated symptoms without medication. In simpler terms, the upper arm is stimulated to trigger a natural process in the brain that aborts or relieves the migraine and other associated symptoms. Each treatment lasts 45 minutes and is applied every other day for prevention or at the beginning of a migraine attack for acute treatment.
About TheranicaTheranica is a digital prescription therapies company dedicated to creating effective, safe, affordable, and low-side-effect treatments for idiopathic pain. Nerivio®, the company’s award-winning flagship wearable device, is the first FDA-cleared and CE-marked prescription migraine neuroband for the acute and/or preventive treatment of migraine with or without aura in people 12 years and older . Nerivio already serves more than 50,000 people with migraine in the United States, including adolescents and veterans. Theranica is expanding its patented technology to develop solutions for other idiopathic conditions. For more information, visit our websites, theranica.com and nerivio.com, and follow us on LinkedIn, Twitter, Instagram and Facebook.
Contact for TheranicaRonen Jashekronenj@theranica.com 972-72-390-9750
Media ContactV.A. LopesGrey Matter Marketingvlopes@greymattermarketing.com
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