Clinical data on Nerivio® for migraines
The six main clinical studies conducted with Nerivio® are described below.
- Episodic migraine: Double-blind single-center study (Pilot study)
- Episodic migraine: Double-blind multi-center study (Pivotal study)
- Chronic migraine: Open label multi-center study (Pilot study)
- Chronic migraine: Open label multi-center study (Pivotal study)
- Adolescents with migraine: Open label multi-center study (Pivotal study)
- Migraine prevention: Double-blind multi-center study (Pivotal study)
Nerivio was evaluated in six clinical studies. The first study was a prospective, double-blind, randomized, crossover, sham-controlled pilot study. The second study was a multi-center, prospective, randomized, double-blind, sham-controlled pivotal study.
Two studies were prospective, open label studies that evaluated the safety and efficacy of the Nerivio device in patients with chronic migraines (>15 headache days per month)
The fifth study was a prospective, open label study that evaluated the safety and efficacy of the Nerivio device in adolescent patients (aged 12-17). The sixth study was a prospective, double-blind, randomized, crossover, sham-controlled study that evaluated the safety and efficacy of the Nerivio device as a migraine preventive therapy.
Episodic migraine: Double-blind single-center study (Pilot study)
The results of the pilot study were published in Neurology, March 2017:
The pilot study was a single-center, prospective, double-blind, randomized, crossover, sham-controlled pilot study aimed to assess the safety and efficacy of non-invasive remote electrical neuromodulation (REN) with the Nerivio device for the acute treatment of migraine. In this study, 86 people with migraine with or without aura (in accordance with International Classification of Headache Disorders [ICHD] classification criteria) who had 2–8 attacks per month without preventive medications for at least 2 months were recruited. The participants were requested to treat migraine episodes at home using the device, which randomly provided one of four different stimuli programs differentiating in pulse width and one sham stimulus. Pain levels were…
Episodic migraine: Double-blind multi-center study (Pivotal study)
The results of the pivotal study were published in Headache, May 2019:
This study was a prospective, randomized, double-blind, sham controlled multi-center pivotal study aiming to demonstrate the efficacy and safety of Nerivio. The study was performed in 7 sites in the USA and 5 sites in Israel. The study initiation was in December 2017. The first randomization procedure was performed at the end of January 2018. The end of the double-blind phase was in October 2018. Eligible patients were 18–75 years old females and males who met the International Classification of Headache Disorders (ICHD) third edition criteria for migraine with or without aura, with at least two and no more than eight migraine headaches per month, with no…
Chronic migraine: Open label multi-center study (Pilot study)
The results of the pilot study were published in Pain and Therapy, July 2020
This study was a prospective, open-label, single arm, multicenter study conducted at 2 sites. 42 patients were recruited in this study. Eligible participants were adults (18–75 years old) who met the International Classification of Headache Disorders (ICHD-3) criteria for chronic migraine (at least 15 headache days a month, with at least eight days a month on which their headaches and associated symptoms meet diagnostic criteria for migraine). Participants treated their migraine attacks at home for 4 weeks (treatment phase), within one hour from migraine symptom onset. Participants were instructed to avoid taking rescue medications prior or within two hours post-treatment. Pain scores, absence/presence of associated migraine symptoms,…
Chronic migraine: Open label multi-center study (Pivotal study)
The results of the main study were published in Pain Reports, November 2021
This was a prospective, open-label, single arm, multicenter study conducted at 9 sites in the USA. Eligible participants were adults (18–75 years old) who met the International Classification of Headache Disorders (ICHD-3) criteria for chronic migraine (at least 15 headache days a month, with at least eight days a month on which their headaches and associated symptoms meet diagnostic criteria for migraine). Following a 4 weeks “Run-in” phase, eligible participants were asked to treat their migraine attacks at home for 4 weeks with their optimal stimulation intensity, as soon as possible after migraine headache began and always within one hour of attack onset. Participants were instructed to
Adolescents with migraine: Open label multi-center study (Pivotal study)
The results of the pivotal study were published in Headache, December 2020
A clinical study of the Nerivio device in adolescents with migraine (ages 12-17 years old) was performed to assess the safety and clinical efficacy of Nerivio in adolescents with migraine. The study was a prospective, open-label, single arm, multicenter study conducted at 12 sites in the USA. Eligible participants were adolescents (12–17 years old, inclusive) who met the International Classification of Headache Disorders (ICHD-3) criteria for migraine. all the inclusion criteria and none of the exclusion criteria. Following a 4 week “run-in” phase, eligible participants were asked to treat 4 qualifying migraine attacks at home with their optimal stimulation intensity, as soon as possible after migraine headache…
Migraine prevention: Double-blind multi-center study (Pivotal study)
The results of the pivotal Prevention study were published in Headache, January 27 2023
This was a Randomized, Controlled Trial (RCT) of the Nerivio device in migraine patients to assess the Nerivio safety and clinical efficacy in prevention of migraine. Specifically, it assessed the capability of the Nerivio device to reduce the number of migraine days, number of headache days and number of moderate/severe headache days in patients with migraine. The study was in compliance with 21 CFR parts 50, 56, and 812. The study was a prospective, randomized, sham-controlled, multicenter study conducted at 15 sites. Eligible participants were adults (18–75 years old) who met the International Classification of Headache Disorders (ICHD-3) criteria for migraine, with 6 to 24 headaches per…
