After Theranica’s remote electrical neuromodulation was approved for those aged 12 years and older with migraine, study investigator Jennifer McVige, MD, MA, shared her insight.
Last week, the FDA cleared an expanded indication for the Nerivio migraine device for acute treatment of episodic or chronic migraine in adolescents aged 12 years and older.1
Theranica’s remote electrical neuromodulation (REN) device won approval based on the recently published data from a single-arm, multicenter study of adolescents aged 12 to 17 years with migraine, which consisted of 45 participants with episodic and chronic disease. They completed a test treatment with the device and found there to be only 1 device-related adverse event (AE; 2%) which was a temporary feeling of pain in the arm. There were no device-related serious AEs found.2
Additionally, according to the study published in Headache, pain relief and pain freedom at 2 hours were achieved by 71% (28 of 39 participants) and 35% (14 of 39) of participants, respectively.
To find out more about the clinical implications of this news about the device and its new indication, as well as to inquire about the current state of affairs in pediatric migraine NeurologyLive reach out to Jennifer McVige, MD, MA, pediatric neurologist, DENT Neurologic Institute, and an investigator of the safety study.
Jennifer McVige, MD, MA: I believe the biggest impact that new treatment for kids will have is an evidence-based treatment for migraine in children. Nerivio has been proven to be effective and safe, as well as easy to use. Compared to oral pharmaceutical medications, the side effects are minimal.
The current treatment paradigm to acutely treat headaches involves NSAIDS, triptans, rest, and a cold compress. Preventative medication involves medicines that were not initially meant to treat migraine, such as antiepileptic and antidepressant medications, as well as diet modification and vitamins.
Kids have a hard time describing their pain. Therefore, getting an appropriate migraine diagnosis is difficult. Many adults still have the misconception that children cannot have migraine. This is incorrect. Treating children for migraine is hindered by the lag in diagnosis and the very limited treatment options for children with migraine.
It was impressive that at 2 hours post-treatment, 69% of participants experienced improved functional ability, 71% pain relief, and 35% pain freedom. The biggest goal in treatment is getting back to regular activities and function. The most encouraging result was that only one person (2%) reported a temporary adverse event.
I do think that having a non-pharmacologic treatment is a game-changer. Not only neurologists, but pediatricians may now feel more comfortable prescribing this treatment to kids due to the limited side effects. This may encourage other companies with device products to look towards pediatrics for a new indication.
Transcript edited for clarity.