Commentary
Video
Advancing the Treatment of Pediatric Migraine With Nerivio REN Wearable: Klaus Werner, MD & Alon Ironi
The pediatric neurologist at Duke Health and chief executive officer at Theranica talked about a remote electrical neuromodulation wearable that showed promising results for the treatment and prevention of migraine in pediatric patients. [WATCH TIME: 5 minutes]
WATCH TIME: 5 minutes
"The [REN wearable] is indicated from the age of 8 and above, both for acute and preventive treatment, and has shown very good data in adolescents over a 6-month period."
Migraine is a chronic and debilitating neurological disorder affecting approximately 1 billion patients globally, including 10% of pediatric patients.1 Effective management, both acute and preventive, is essential for these patients who are living with migraine, especially for those in pediatric populations.2 Thus, early diagnosis and intervention may be important to prevent long-term disability and the potential progression of the condition into adulthood. Among pediatric patients, untreated migraine could severely impact daily functioning, disrupting school attendance, social interactions, and sleep patterns, which can ultimately lead to a marked decline in overall quality of life.3
In recent news, the FDA approved an expanded age indication for Theranica's Nerivio remote electrical neuromodulation (REN) wearable to treat pediatric patients aged 8 years and older with acute migraine.4 This decision comes following a recent study (NCT06138756) led by Klaus Werner, MD, PhD, which showed that the REN wearable was safe and effective for treating acute migraine in patients aged between 6 years and 11 years.5 The study featured 293 patients with a median age of 11 years who used the REN wearable to treat at least 1 migraine attack. Of them, 18.4% reported at least 1 attack with aura, and the remaining 81.6% never reported aura. Notably, two-thirds (67.4%) of REN treatments were not followed by another REN treatment in 24 hours, indicating no retreatment and implying no recurrence in 24 hours.
At the 53rd Child Neurology Society (CNS) Annual Meeting, held November 11-14, in San Diego, California, Werner, pediatric neurologist at Duke Health, presented real-world data on the REN wearable for acute migraine treatment.5 During the meeting, both Werner and Alon Ironi, CEO and co-founder at Theranica, sat down with NeurologyLive® talk about how the future landscape of pediatric migraine treatment could evolve following Nerivio’s expanded indication. The duo also spoke about how this patient population responded to the noninvasive migraine treatment compared with traditional medication observed in clinical practice. Furthermore, the experts discussed the challenges that could be foreseen in implementing this new treatment across various pediatric populations.
REFERENCES
1. Kabbouche MA, Gilman DK. Management of migraine in adolescents. Neuropsychiatr Dis Treat. 2008;4(3):535-548. doi:10.2147/ndt.s495
2. Charles JA, Peterlin BL, Rapoport AM, Linder SL, Kabbouche MA, Sheftell FD. Favorable outcome of early treatment of new onset child and adolescent migraine-implications for disease modification. J Headache Pain. 2009;10(4):227-233. doi:10.1007/s10194-009-0133-3
3. Szperka C. Headache in Children and Adolescents. Continuum (Minneap Minn). 2021;27(3):703-731. doi:10.1212/CON.0000000000000993
4. FDA Expands the Age Indication for Nerivio® as the First-and-Only REN Wearable for Migraine Treatment for Children Aged Eight and Above. News Release. Theranica. Published November 14, 2024. Accessed November 14, 2024. https://nerivio.com/press-releases/fda-expands-the-age-indication-for-nerivio-as-the-first-and-only-ren-wearable-for-migraine-treatment-for-children-aged-eight-and-above/
5. New Study Evaluates Use of the Nerivio® REN Wearable for Treatment of Migraine in Children Under the Age of 12. News release. Theranica. July 25, 2024. Accessed November 12, 2024. https://www.prnewswire.com/news-releases/new-study-evaluates-use-of-the-nerivio-ren-wearable-for-treatment-of-migraine-in-children-under-the-age-of-12-302206102.html
6. Werner K, Gerson T, Stark-Inbar, et al. Real-World Evidence of Remote Electrical Neuromodulation (REN) for the Acute Treatment of Migraine in Children Aged 6-11. Presented at 2024 Child Neurology Society (CNS) Annual Meeting: November 11-14, in San Diego, California.
