Theranica has announced the peer-reviewed publication of a comprehensive clinical study showing the preventive benefits of its remote electrical neuromodulation (REN) wearable, Nerivio, for adolescents suffering from migraine. The study—published in Frontiers in Pain Research—demonstrates that frequent use of Nerivio can significantly reduce the number of monthly migraine treatment days (MMTD) in adolescents, a company press release relays.
The study analysed 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 being treated with the device. 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 (±4.8; p<0.001, t-test) MMTD over the three-month period.
Teshamae Monteith (University of Miami Miller School of Medicine, Miami, USA), lead author of the study, emphasised the importance of preventive treatment to improve brain function and quality of life in these patients.
“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 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 is 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 that the REN wearable provided a consistent acute response over a two-hour period in at least 50% of the treated attacks, with 61.9% of participants reporting consistent pain relief post two 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 two hours.
In addition, Theranica claims in its recent release that using the REN wearable resulted in a consistent post-two-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 adolescent participants, disappearance of phonophobia in 50%, disappearance of nausea/vomiting in 65.9%, and disappearance of at least one associated symptom in 65.9%.
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, according to Theranica.
“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, 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 [Food and Drug Administration]-cleared ‘combo’ therapy offers effective, easy relief at home or school, and is a beneficial dual-use addition to the clinicians’ toolbox.”
Earlier this month, Theranica also announced an exclusive agreement with Dr. Reddy’s Laboratories for the commercial marketing and distribution of Nerivio in Austria, Czech Republic, Denmark, Finland, France, Italy, Norway, Poland, Slovakia, Spain, Sweden, Switzerland and the UK—in addition to Germany, which had been agreed on earlier.
News of this agreement followed Theranica’s August 2023 announcement that Nerivio had received an expanded CE-mark approval under the European Medical Device Regulation (MDR) as a dual-use (acute and/or prevention) migraine treatment for adults and adolescents.
