New Study Found Preventive Impact in Adolescents Who Frequently Used Nerivio® for Abortive Treatment of Migraine

New Frontiers in Pain Research Study Demonstrates a Reduction in Migraine Days in Teenagers Using the REN Wearable

NETANYA, Israel and BRIDGEWATER, N.J.Nov. 28, 2023 /PRNewswire/ — Theranica, a neuromodulation therapeutics company, announced the peer-reviewed publication of a comprehensive clinical study showing the preventive benefits of their REN wearable, Nerivio®, for adolescents suffering from migraine. The study, published in Frontiers in Pain Research, demonstrated that frequent use of Nerivio can significantly reduce the number of monthly migraine treatment days (MMTD) in adolescents.

The study ( Identifier: NCT05769322) analyzed prospective real-world data from 83 adolescents who used the REN wearable for acute migraine treatment at least 10 times in their first month of using REN. Over three consecutive months of treatment, the mean MMTD decreased from 12.6 [±3.2] in the first month to 7.4 [±4.2] in the third month, resulting in a total reduction of 5.2 (SD = ±4.8, p < 0.001, t-test) MMTD over the 3-month period.

Teshamae Monteith, MD, FAHS, FAAN, associate professor of clinical neurology and chief of the Headache Division in the Department of Neurology at the University of Miami Miller School of Medicine, and lead author of the study, emphasized the importance of preventive treatment to improve brain function and quality of life. “Using a preventive migraine treatment is highly important for people living with migraine, especially adolescents, who have 5 – 6 monthly headache days or more,” said Dr. Monteith. “Adhering to a preventive treatment also may reduce the possibility of further migraine deterioration and chronification. Migraine often starts early around puberty, so it’s imperative to quickly diagnose it correctly and apply an effective therapy regime that teenagers can adhere to in the midst of their hectic daily routines.”

The study also revealed the REN wearable provided a consistent acute response over a 2-hour period in at least 50% of the treated attacks, with 61.9% of participants reporting consistent pain relief post 2 hours, 24.5% reporting pain freedom, 67.4% reporting some relief from functional disability, and 41.3% reporting complete disappearance of their functional disability post 2 hours. Moreover, using the REN wearable resulted in a consistent post-2-hour disappearance of associated migraine symptoms in at least 50% of the attacks in which such symptoms were present at the beginning of the treatment, with disappearance of photophobia in 39.5% of the participants, disappearance of phonophobia in 50.0% of the patients, disappearance of nausea/vomiting in 65.9%, and disappearance of at least one associated symptom in 65.9% of the adolescent patients.

The study highlights the urgent need for effective and safe treatment options for the 100,000,000 adolescents living with migraine, a group for whom FDA-approved preventive treatments are scarce. Many adolescents and their parents are hesitant to use prescription drugs due to side effects and issues with treatment adherence. The REN wearable is the only non-pharmacological, evidence-based treatment for migraine that can be easily used and discreetly worn during daily activities or at school.

“We carefully designed Nerivio considering how adolescents would be able to use it safely and discreetly at school, without having to approach the school nurse, while they continue their daily routine of classes and social and sports activities,” said Alit Stark Inbar, neuroscience Ph.D., Vice President of Medical Information at Theranica and co-author of the study. “Practice guidelines from the American Academy of Neurology (AAN) and American Headache Society (AHS) suggest that preventive treatments should be considered for adolescents if the frequency and severity of headaches leads to migraine-related disability. However, evidence-based options for adolescents are limited, and some families hesitate to use prescription medications. Our non-pharmacological, FDA-cleared ‘combo’ therapy offers effective, easy relief at home or school, and is a beneficial dual-use addition to the clinicians’ toolbox.”

Theranica is committed to supporting those with migraine who are restricted in their drug use, such as teenagers, pregnant women, veterans, or active-duty service persons. Initially, the company focused on teenagers in the US, and is now bringing complete migraine care to adolescents and pediatricians in many other parts of the world. Earlier this year, an agreement was announced between Theranica and Dr. Reddy’s Laboratories Ltd to commercialize the REN wearable in India and Europe.

About Nerivio

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 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 headaches 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.