Randomized Placebo-Controlled Study Published in Pain Management Evaluated the Preventive Efficacy of the Non-Drug Wearable As Early As After Two Weeks of Usage
NETANYA, Israel and BRIDGEWATER, N.J., Sept. 12, 2023 /PRNewswire/ — Theranica, a neuromodulation therapeutics company, announced the results of a study recently published in Pain Management, suggesting the rapid impact of Nerivio, the first and only migraine neuroband, in reducing the number of migraine days.
A previous study has already shown that using Nerivio every other day for 8 weeks reduces the mean number of migraine days per month by 4.0 days (compared to 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 in two-week intervals and compared between the 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 the preventive response at time points earlier than 8 weeks. The findings were that, already after two weeks of usage, there was a statistically significant mean 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 usage a 3.1 days reduction (compared to 1.5 days in placebo, p=0.025).
Preventive treatment is key to managing and mitigating the burden of migraine. A key challenge in the treatment of migraine is that many preventive medications take a relatively long time to take effect, with some taking a few months. This might make it difficult for people living with migraine, especially adolescents. This new publication suggests rapid, sustained reduction in monthly migraine days when using Nerivio every other day.
“These results suggest that the preventive impact of REN kicks-in rather early after starting it every other day,” says Andrea Harriott, a neurologist at Massachusetts General Hospital and Assistant Professor at Harvard Medical School, who is one of the authors of the new study. “This study demonstrates that Nerivio addresses patients’ preferences by providing rapid onset of action, coupled with high efficacy and low occurrence of side effects.”
In another study, published earlier this year in Headache, people living with migraine were asked to rate which factors mattered most to them to be satisfied with their migraine preventive treatment. Effectiveness and speed of onset were the top-ranking factors. Other studies have also found similar results, showing that people with migraine value treatments that start working fast.
“For medical solutions to have real patient-centered meaning, you must be hyper-attentive and committed to understanding patient needs and be open to creating out-of-the-box therapies to migraine management,” says Alon Ironi, CEO and co-founder of Theranica. “Migraine disease is extremely debilitating. People living with migraine need fast results so that they can continue with their normal activities, which is why we are so excited about this latest prevention data. It further demonstrates the important clinical benefits that Nerivio offers to adults and adolescents living with 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 nerves fibers in the arm to send signals which trigger a descending pain management mechanism 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 unleash a natural process in the brain to abort or relieve migraine headache and other associated symptoms. Each treatment lasts 45 minutes and is applied every other day for prevention or at the start of a migraine attack for acute treatment.
About Theranica
Theranica is a prescribed digital therapeutics company dedicated to creating effective, safe, affordable, low-side-effect therapies for idiopathic pain conditions. The company’s award-winning flagship wearable, Nerivio®, is the first FDA-cleared and CE- marked prescription migraine neuroband for acute and/or preventive treatment of migraine with or without aura in people 12 years or older. Nerivio already serves more than 50,000 people with migraine in the USA, including adolescents and veterans. Theranica is expanding its proprietary technology to develop solutions for additional idiopathic pain conditions. Learn more by visiting our websites, theranica.com and nerivio.com, and following us on LinkedIn, Twitter, Instagram and Facebook.
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