Theranica recently had the results from a real-world analysis of Nerivio for acute treatment of migraine in adolescents published in the journal Pediatric Neurology. The study demonstrates the ease of use, safety and efficacy of Nerivio—the company’s remote electrical neuromodulation (REN) device—as an acute treatment for migraine in adolescents, and reflects findings from previous clinical trials in adolescents and similar real-world studies in adults.
This further supports the US Food and Drug Administration (FDA) indication of Nerivio as a dual use (acute and/or preventive) treatment for migraine with or without aura in people aged 12 and older, as per a company press release.
The present study analysed prospective, real-world data collected from 1,629 adolescents (aged 12–17) with migraine, treated with Nerivio over a period of a year and a half.
Results showed that, when Nerivio was used as a standalone therapy, 60.3% of the adolescent users achieved post two-hour pain relief from severe or moderate headache, to mild or no headache, in at least half of their evaluable treatments, and 26.3% of users were completely pain-free after at least half of their treatments. Additionally, 66.3% and 41.2% of users experienced relief or complete freedom, respectively, from functional disability.
In nearly 65% of treatments, users did not take any medication within two hours of starting Nerivio. Of the users who combined Nerivio with medication, 17% used prescription medications and 18% used over-the-counter medications, with similar pain relief results observed in both. Only three device-related adverse events—all of which were minor—were reported out of the 13,682 treatments conducted across 1,629 patients.
“Migraine must be treated early and holistically, with a comprehensive plan tailored for each child’s needs, symptoms, and lifestyle,” said Rashmi Rao (Children’s Hospital New Orleans, New Orleans, USA), a co-author of the study. “For parents and teens, these data add to established clinical efficacy and demonstrate the significant real-world benefits of Nerivio, either as a standalone therapy or as an adjunct to other treatments, as a valuable non-drug tool to treat migraine.”
Nerivio is designed to offer migraine patients a convenient therapeutic option that is well-tolerated, allowing users to continue activities with minimal interruption and low risk of adverse events, and no risk of sedation or addiction. The novel physician-prescribed wearable is the only US FDA-cleared acute and preventive migraine treatment that is purpose-built for young adults, a Theranica press release states.