CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 293 enrolled
Drug / intervention
Neriviodevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06138756
NCT06138756N/ACompleted
CompareCT.gov

A Prospective, Single Arm, Open Label Post Market Study Assessing the Safety and Efficacy of Nerivio for the Treatment of Migraine in Children Under the Age of 12

Theranica·observational·Posted Nov 18, 2023·Updated Sep 15, 2025

In Brief

An observational study evaluating Nerivio for Migraine. Completed, enrolled 293 participants across 2 sites in 2 countries.

Detailed Summary

Migraine is a prevalent neurological disorder that severely impacts both children and adolescents, causing significant disability. Remote Electrical Neuromodulation (REN) is a nonpharmacological, prescribed, wearable device, FDA-cleared for acute and/or preventive treatment of migraine with or without aura in patients 12 years or older. Multiple studies have shown that REN has high safety, tolerability, and efficacy in adults and adolescents. This study aims to evaluate REN's real-world safety and efficacy in pre-adolescents, 6-11 years old.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine
CountriesIsrael, United States
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedNov 18, 2023
Enrollment StartOct 1, 2023
Primary CompletionMay 18, 2024
Study CompletionJun 1, 2024
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 2.6 years ago

Interventions

Neriviodevice

Nerivio is a remote electrical neuromodulation (REN) device for the treatment of migraine