A Single Arm, Open Label, Multicenter Study of the Safety and Efficacy of Nerivio™ for the Acute Treatment of Migraine in Adolescents

This open label study includes 3 phases and up to 4 visits. All visits will be conducted in the presence of a parent/guardian.

First visit - enrollment: The first visit will include screening, enrollment and training on the application in diary mode. The screening process will include an eligibility assessment and a urine pregnancy test. Following successful screening, enrollment interview and signing an informed consent by the parent/guardian and an informed assent by the participant. The participants will be trained to use the electronic diary application, installed on their own smartphones. The site personnel will be required to document the training session in the CRF. During this visit, participants will complete baseline questionnaires that included information on the frequency and severity of their migraine attacks, typical associated symptoms, use of preventive and acute treatments, and the effect that their migraine attacks have on their daily routine and quality of life.

Phase 1 - run-in phase: After the enrollment visit, participants will undergo a 4-week migraine diary phase aimed to collect baseline migraine characteristics and further assess eligibility. Participants will be asked to report in the application each migraine attack. These reports will be transferred by the application to the electronic data collection (EDC) system, where they will be collected and registered. Participants who did not have at least 3 migraine attacks will be excluded from the study. Eligibility will also be determined based on the compliance of participants to report the attacks within one hour from attack onset and report the pain level at 2 hours post-treatment in at least 66.7% of the reported attacks.

Second visit - Device training visit: Eligible participants who meet the run-in requirements will receive the Nerivio™ device. The device will be registered and connected by Bluetooth to their smartphone. During this visit, participants and their parent/guardian will be trained to use the device, including finding the optimal individual stimulation intensity level (perceptible but not painful). The site will also carefully review with the patient and parent/caregiver how to identify a qualifying migraine attack (see below) and provide detailed instructions on study procedures.

The individual intensity level identified during this visit will be recorded, and the participants will be asked to treat their migraine headaches with the device using the identified intensity. If the research staff recognizes that the participant cannot tolerate the feeling of the electrical stimulation, the participant may be withdrawn from the study.