NCT06023953

Brief Summary

This is a Post-marketing, real-world evidence study investigating the safety and efficacy of the acute treatment of migraine with a Remote Electrical Neuromodulation (REN) device (Nerivio) in migraine patients with and without aura, as well as characterizing demographic and attack characteristic differences between migraine patients with and without aura. Safety will be assessed by the number and type of device-related adverse events. Efficacy will be evaluated as a change in headache pain severity from baseline to 2 hours post-treatment. Disease characteristics will look into demographic and attack differences between patients with and without aura.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31,715

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 5, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

August 15, 2025

Status Verified

August 1, 2025

Enrollment Period

1.3 years

First QC Date

August 29, 2023

Last Update Submit

August 11, 2025

Conditions

Migraine With AuraMigraine Without Aura

Keywords

MigraineAuraRENNerivio

Outcome Measures

Primary Outcomes (2)

  • Comparison of consistent Headache Relief at 2 Hours Post-treatment between the MWA and MWoA groups

    The difference between the MWA and MWoA groups in the proportion of subjects reporting headache relief at 2 hours post-treatment in at least 50% of all their treatments. Headache relief is defined as an improvement from severe or moderate pain to mild or no pain.

    2 hours

  • Comparison of Headache Severity at treatment baseline (T=0h) between the MWA and MWoA groups

    The difference between the MWA and MWoA groups in the proportion of subjects reporting severe/moderate headache pain in at least 50% of their attacks.

    0 hours (at baseline)

Secondary Outcomes (7)

  • Comparison of consistent Pain Freedom at 2 Hours Post-treatment between the MWA and MWoA groups

    2 hours

  • Comparison of Functional Disability at treatment baseline (T=0h) between the MWA and MWoA groups

    0 hours (at baseline)

  • Comparison of Photophobia, Phonophobia and Nausea/vomiting presence at treatment baseline (T=0h) between the MWA and MWoA groups

    0 hours (at baseline)

  • Comparison of Consistent Functional Disability Relief at 2 Hours Post-treatment between the MWA and MWoA groups

    2 hours

  • Comparison of Consistent Functional Disability Freedom at 2 Hours Post-treatment between the MWA and MWoA groups

    2 hours

  • +2 more secondary outcomes

Study Arms (2)

Migraine with aura (MWA)

Patients with migraine who treated their migraine attack with the Nerivio device at least twice and reported having aura in at least two treatment reports

Device: Nerivio device

Migraine without aura (MWoA )

Patients with migraine who treated their migraine attack with the Nerivio device at least twice and reported the absence of aura in all of their reports, with at least two reports

Device: Nerivio device

Interventions

Nerivio deviceDEVICE

REN treatment with Nerivio device

Migraine with aura (MWA)Migraine without aura (MWoA )

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who were diagnosed with migraine by their HCP and were prescribed Nerivio for treatment of acute migraine

You may qualify if:

  • Users aged 8 years old and above
  • Users who treated their migraine attacks with the Nerivio device at least twice
  • Users who prospectively reported the presence of aura in at least two treatment reports (reporting at least twice having aura) , OR:
  • Users who prospectively reported the absence of aura in all of their reports, with at least two reports

You may not qualify if:

  • Users who prospectively reported having aura only once

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Theranica Bio-Electronics Ltd

Netanya, 4520438, Israel

Location

MeSH Terms

Conditions

Migraine with AuraMigraine without AuraMigraine DisordersEpilepsy

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Alit Stark Inbar, PhD

    Theranica Bio-Electronics Ltd

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2023

First Posted

September 5, 2023

Study Start

July 1, 2023

Primary Completion

September 30, 2024

Study Completion

December 1, 2024

Last Updated

August 15, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)