Trial Outcomes & Findings for Assessment of Safety and Efficacy of Nerivio for the Migraine Prevention (NCT NCT04828707)

The study contained a 4-week baseline phase, an 8-week treatment phase, and 4-week follow-up phase. Participants who had 6-24 headache days and completed at least 22 daily diaries at baseline were eligible to enter the treatment phase. out of the 335 recruited participants, 18 participants did not complete the baseline phase and 69 participants completed the baseline but were non-eligible to continue to the treatment phase. Thus, 248 participants were randomized into the treatment phase.

The analysis was performed on participants who completed the baseline phase and were randomized into the treatment groups

The mean reduction in the number of migraine days per month during the last 28 days (4 weeks) of the treatment phase (weeks 9 through 12) compare to the 4-week baseline phase (weeks 1 through 4) A migraine day is defined as a calendar day with a headache that is accompanied by at least one of the following symptoms: aura, photophobia, phonophobia, nausea and/or vomiting; or a calendar day with a headache that is treated with a migraine-specific acute medication.

Number of participants with Adverse Events (AE), Serious Adverse Events (SAE) and Device-related Adverse Events

The mean reduction in the number of moderate/severe headache days per month during the last 28 days (4 weeks) of the treatment phase (weeks 9 through 12) compare to the 4-week baseline phase (weeks 1 through 4) A moderate/severe headache day is defined as a calendar day with a moderate or severe headache.

The mean reduction in the number of headache days per month during the last 28 days (4 weeks) of the treatment phase (weeks 9 through 12) compare to the 4-week baseline phase (weeks 1 through 4) A headache day is defined as a calendar day with headache (at any severity).

Percentage of patients achieving at least 50% reduction from baseline in the mean number of headache days (all severities) per month in the last 4 weeks of the treatment phase (weeks 9 through 12).

Headache Impact Test-6 (HIT-6) questionnaire is a tool used to measure the impact headaches have on your ability to function on the job, at school, at home, and in social situations. the questionnaire contains 6 questions with a total score between 36 to 78. Higher score interpret as better patient outcome.

The migraine Specific Quality-of-Life questionnaire (MSQ) is a tool to measure the impact of migraine on your ability to function on the job, at school, at home, and in social situations. The questionnaire contains 14 questions with a total score between 0 to 84. Lower score interprets as better patient outcome.

Reduction in the mean number of acute headache/migraine medication days per month in the last 4 weeks of the treatment phase (weeks 9 through 12) compared to baseline (weeks 1 through 4).

Percentage of participants who treat for the first treatment in the pre-emptive phase, during the prodrome, when they are pain-free, and remain pain-free during the following 2 hours after the treatment, without use of acute medication.

Percentage of participants who treat for the first treatment in the pre-emptive phase, during the prodrome, when they are pain-free, and remain pain-free during the following 24 hours after the treatment, without use of acute medication.

Percentage of patients who treat during the prodrome, when they are pain free, and remain either pain free or with mild pain during the following 24 hours after the treatment without use of acute medication.

Analysis of the daily information provided by the participants for the purpose of predicting their migraine days

Health economics analysis of the difference between subjects using Nerivio as a therapy and those who do not with respect to: 1. Absenteeism - number of missed work/school days 2. Presenteeism - number of work/school days with moderate/severe functional disability 3. Healthcare provider appointments 4. ED visits 5. Brain MRI/CT scans