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

Study Overview
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Brief Summary
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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.

Detailed Description
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This study aims to evaluate the safety and efficacy of Nerivio for the acute treatment of menstrual migraine (pure menstrual migraine or menstrually-related migraine). Up to 500 US-based adults aged 18-55 years old who have been prescribed the Nerivio device and have used it at least 4 times between October 2019 and December 2020. Informed consent must be obtained from the participant before any protocol-related activities are performed. 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. Users of Nerivio whose details are in the sponsor's database will be contacted by email (provided by the patient during the sign-up process in the Nerivio app required to use the device) and/or through an app notification and will be asked to complete a 5-minute online survey assessing satisfaction, effectiveness, and safety. Participants will sign an informed consent form which will appear as the first page of the survey using open-ended questions, multiple choice questions and Likert scales. Participants will be directed to provide honest opinions regarding the device use for menstrual migraine. No additional information will be collected, and no medical records will be used in this investigation.

Official Title
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Retrospective, Observational Survey Study to Assess the Efficacy and Safety of Nerivio for the Acute Treatment of Menstrual Migraine

Conditions
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Menstrual Migraine

Intervention / Treatment
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* Device: Nerivio


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 18-55 years Participants have used Nerivio at least 4 times Participants experience menstrual migraines (pure menstrual migraine or menstrually-related migraine; self-reported) Participants have used Nerivio to treat menstrual migraine Exclusion Criteria: 1. Non-menstruating women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Nerivio|Nerivio Remote Electrical Neuromodulation (REN) device|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Nerivio during menstrual migraines | Efficacy of Nerivio for headache relief during menstrual migraines rated on a 5-point Likert scale (1 - Not at all effective, 2 - Slightly effective, 3 - Moderately effective, 4 - Very effective, 5- Extremely effective) | 3 months | 
| Satisfection of using Nerivio during menstrual migraines | Satisfection of using Nerivio during menstrual migraines rated on a 5-point Likert scale )1 - Not at all satisfied, 2 - Slightly dissatisfied, 3 - Neutral, 4 - Slightly satisfied, 5 -Extremely satisfied) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean headache relief | Mean percentage of menstrual migraine attacks in which relief was achieved | 3 months | 
| Medication consumption | Percentage of menstrual migraine attacks in which acute medication was avoided following using the Nerivio | 3 months | 
| Reduction of menstrual cramps | Percentage of patients reports reduction in menstrual cramps following using of Nerivio | 3 months |