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Efficacy and Safety of Nerivio for the Acute Treatment of Menstrual Migraine

NCT04600388 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 121

Last updated 2020-12-04

No results posted yet for this study

Summary

Post-marketing, retrospective, observational survey study. Users (menstruating women only) of Nerivio who have used Nerivio at least 4 times between October 2019 and December 2020 will be contacted by email and/or through an app notification and will be asked to complete a 5-minute online anonymous survey assessing satisfaction, effectiveness, and safety. Eligible users will sign an informed consent form (the consent language will appear as the first page of the survey, and participants will click either "agree" or "disagree" to the consent statement; those who click "agree" will proceed to the survey, those who click "disagree" will be brought to an exit page) and complete a survey asking about their satisfaction with Nerivio and the effectiveness and safety of the device for acute treatment of menstrual migraine. During the survey, participants will be screened to verify that they have menstrual migraine (self-reported) and have used Nerivio to treat menstrual migraines.

Conditions

  • Menstrual Migraine

Interventions

DEVICE

Nerivio

Nerivio Remote Electrical Neuromodulation (REN) device

Sponsors & Collaborators

  • Theranica

    lead INDUSTRY

Principal Investigators

  • Hida Nierenburg, MD · Nuvance Health

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-09
Primary Completion
2020-11-01
Completion
2020-11-10
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT04600388 on ClinicalTrials.gov