Ignite Creation Date:
2024-05-06 @ 7:15 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05940870
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-23
First Post:
2023-06-28
Brief Title:
A Prospective Post-marketing Observational Study Assessing the Safety and Efficacy of Nerivio for Migraine Prevention
Sponsor:
Theranica
Organization:
Theranica
Study Overview
Official Title:
A Prospective Open-label Post-marketing Observational Study Assessing the Safety and Efficacy of Nerivio for Migraine Prevention in Real-world Environment
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Nerivio is a remote electrical neuromodulation REN device that is FDA-cleared for migraine prevention as well as for acute treatment of migraine in individuals 12 and older The study is a post-marketing observational prospective real-world evidence study assessing the safety efficacy and health economics outcomes of Nerivio for migraine prevention in a real-world environment The study population is naïve Nerivio users aged 12 and up who were prescribed Nerivio by their healthcare provider for either prevention treatment for use every other day or dual-use treatment for use every other day and upon the onset of a migraine The study period per participant is six months During this period participants will be requested to use Nerivio according to the instructions of their healthcare provider and to fill out a short daily questionnaire in the Nerivio application
Detailed Description:
Nerivio is an FDA-approved remote electrical neuromodulation REN device for the acute andor preventive treatment of migraine with or without aura Nerivio delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation CPM that activates a descending endogenous analgesic mechanism The treatment is self-administered and controlled by a smartphone application The study will assess the safety and efficacy of Nerivio used every other day for prevention and possibly whenever needed for acute treatment as prescribed to participants by their own healthcare provider The study will also assess certain health economics outcomes related to the treatment
Patients aged 12 or above who were prescribed Nerivio for prevention or dual-use treatment of migraine after April 1st
New Nerivio users will be sent an invitation message via in-app notification and email inviting them to fill out a Screening Eligibility Questionnaire Those who meet the eligibility criteria will be offered to participate in the study Candidate participants will then complete and sign an electronic Informed Consent Form ICF Immediately following this participants will receive a Baseline Questionnaire with questions relating to the time period prior to using Nerivio
The study duration for each participant is 24 weeks During this time participants will fill out the Daily Diary in the Nerivio App In the middle of the study period end of week 12 and at the end of the 24 weeks participants will be asked to fill out follow-up questionnaires Mid-study questionnaire Completion questionnaire with questions on migraine and related symptoms medication intake health economics and satisfaction with the treatment
Participants who stop treatment will be sent a Completion questionnaire concerning the reason for their withdrawal
Patients aged 12 or above who were prescribed Nerivio for prevention or dual-use treatment of migraine after April 1st
New Nerivio users will be sent an invitation message via in-app notification and email inviting them to fill out a Screening Eligibility Questionnaire Those who meet the eligibility criteria will be offered to participate in the study Candidate participants will then complete and sign an electronic Informed Consent Form ICF Immediately following this participants will receive a Baseline Questionnaire with questions relating to the time period prior to using Nerivio
The study duration for each participant is 24 weeks During this time participants will fill out the Daily Diary in the Nerivio App In the middle of the study period end of week 12 and at the end of the 24 weeks participants will be asked to fill out follow-up questionnaires Mid-study questionnaire Completion questionnaire with questions on migraine and related symptoms medication intake health economics and satisfaction with the treatment
Participants who stop treatment will be sent a Completion questionnaire concerning the reason for their withdrawal
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None