The Nerivio app includes a secured, personal migraine diary, which patients can use to record their symptoms before the treatment and 2 hours post-treatment, as well as additional symptoms and medication intake. Real-world data on Nerivio treatments were collected via the app from adolescent patients (aged 12-17) across the United States who used Nerivio between January 1st, 2021 to May 31st 2022.  Study’s endpoints included consistent efficacy 2 hours after treatment, use of REN as a standalone versus as an adjunct therapy, treatment intensity, and safety.

Effectiveness analyses were conducted on data from 1,629 adolescent users who performed at least two treatments with voluntary reports of pain level before and after the treatment (and not taking any medications during the 2 hours from starting a REN treatment). Reports of adverse events are analyzed for all 1,629 users, who performed a total of 13,682 treatments.

Results:

• Treatment effectivity: 60.3% of the users achieved pain relief in at least half of their treatments, 26.3% achieved pain freedom in at least half of their treatments, 66.3% reported improvement in functional ability in at least half of their treatments, and 41.2% experienced a return to normal function in at least half of their treatments.

• Use of medications: In 64.4% of the treatments, users did not take any additional medications within two hours from the beginning of the treatment. In 18.6% of the treatments an over-the-counter medication was used, and only in 17% of the treatments a prescription medication was used (7.6% with oral triptans, 9.4% with other prescription medications).

• Adverse events: Only 3 device-related adverse events were reported, all minor.

Conclusions: Large-scale real-world data confirms that Nerivio is safe and efficacious for the acute treatment of migraine in adolescents.

Source: Esparham A, Stark-Inbar A, Jekel L, et al. Acute Treatment of Migraine in Adolescents: Real-World Analysis of Remote Electrical Neuromodulation (REN). Pediatric Neurol. February, 2023