NCT05940870

A Prospective Post-marketing Observational Study Assessing the Safety and Efficacy of Nerivio for Migraine Prevention.

A Prospective, Open-label, Post-marketing Observational Study Assessing the Safety and Efficacy of Nerivio for Migraine Prevention in Real-world Environment.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 250 (actual)
• Sponsor: Theranica · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

Nerivio is a remote electrical neuromodulation (REN) device that is FDA-cleared for migraine prevention (as well as for acute treatment of migraine), in individuals 12 and older. The study is a post-marketing, observational, prospective, real-world evidence study assessing the safety, efficacy, and health economics outcomes of Nerivio for migraine prevention in a real-world environment. The study population is naïve Nerivio users, aged 12 and up, who were prescribed Nerivio by their healthcare provider for either prevention treatment (for use every other day) or dual-use treatment (for use every other day and upon the onset of a migraine). The study period per participant is six months. During this period, participants will be requested to use Nerivio according to the instructions of their healthcare provider and to fill out a short daily questionnaire in the Nerivio application

Detailed description

Nerivio is an FDA-approved remote electrical neuromodulation (REN) device for the acute and/or preventive treatment of migraine with or without aura. Nerivio delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application. The study will assess the safety and efficacy of Nerivio, used every other day for prevention and possibly whenever needed for acute treatment, as prescribed to participants by their own healthcare provider. The study will also assess certain health economics outcomes related to the treatment. Patients aged 12 or above who were prescribed Nerivio for prevention or dual-use treatment of migraine after April 1st. New Nerivio users will be sent an invitation message (via in-app notification and email), inviting them to fill out a Screening Eligibility Questionnaire. Those who meet the eligibility criteria will be offered to participate in the study. Candidate participants will then complete and sign an electronic Informed Consent Form (ICF). Immediately following this, participants will receive a Baseline Questionnaire with questions relating to the time period prior to using Nerivio. The study duration for each participant is 24 weeks. During this time, participants will fill out the Daily Diary in the Nerivio App. In the middle of the study period (end of week 12), and at the end of the 24 weeks, participants will be asked to fill out follow-up questionnaires (Mid-study questionnaire \& Completion questionnaire) with questions on migraine and related symptoms, medication intake, health economics, and satisfaction with the treatment. Participants who stop treatment will be sent a Completion questionnaire concerning the reason for their withdrawal.

Conditions

• Migraine

Interventions

Type	Name	Description
DEVICE	Nerivio	Patients with migraine who received the Nerivio device for migraine prevention therapy

Timeline

• Start date: 2023-07-03
• Primary completion: 2024-06-30
• Completion: 2024-08-01
• First posted: 2023-07-11
• Last updated: 2024-11-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study