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

NCT05940870 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2024-11-22

No results posted yet for this study

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

Conditions

Interventions

DEVICE

Nerivio

Patients with migraine who received the Nerivio device for migraine prevention therapy

Sponsors & Collaborators

  • Theranica

    lead INDUSTRY

Principal Investigators

  • Alit Stark Inbar · Theranica

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-03
Primary Completion
2024-06-30
Completion
2024-08-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05940870 on ClinicalTrials.gov