Ignite Creation Date:
2024-05-06 @ 1:56 PM
Last Modification Date:
2024-10-26 @ 1:22 PM
Study NCT ID:
NCT04161807
Status:
COMPLETED
Last Update Posted:
2021-02-16
First Post:
2019-11-10
Brief Title:
Efficacy and Safety of Nerivio for Acute Treatment of Migraine in People With Chronic Migraine
Sponsor:
Theranica
Organization:
Theranica
Study Overview
Official Title:
Efficacy and Safety of Nerivio a Remote Electrical Neuromodulation Device for Acute Treatment of Migraine in People With Chronic Migraine an Open Label Single Arm Multicenter Study
Status:
COMPLETED
Status Verified Date:
2019-12
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:
This study is intended to evaluate the efficacy and safety of Nerivio an FDA-authorized remote electrical neuromodulation REN device for the acute treatment of migraine for the acute treatment of migraine in people with chronic migraine The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation CPM that activates a descending endogenous analgesic mechanism The study duration consists of a 4 weeks of active treatment with the device in about 40 patients
Detailed Description:
This open label study includes up to 2 visits The enrollment and device training may occur in 2 separate visits
First visit - The first visit will include screening enrollment and training on the application and device
Treatment phase - Participants will be instructed to use the device for the treatment of qualifying migraine headaches see below as soon as possible and always within 60 minutes of onset during a period of up to 4 weeks Participants will be instructed to use the device with the intensity level identified during the device training visit and adjust as necessary and make sure the stimulation is perceptible but not painful Participants will be instructed to avoid taking rescue medications within 2 hours post-treatment If medications are used participants will be instructed to record in the app when and which medication was taken at 2- and 24-hours post treatment The participants will use the app to record pain intensity levels the presenceabsence of aura and associated migraine symptoms nausea photophobia phonophobia and allodynia l as well as rate their stress level and functional disability at baseline 2- and 24-hours post-treatment At the beginning of each treatment participants will also be asked to report the time elapsed from attack onset Adverse events will be reported throughout this phase of the study directly to the site staff
Participants who do not achieve satisfactory relief at 2 hours post-treatment may treat again with the Nerivio device or may treat with usual care at that time or any time thereafter if the headache does not resolve Participants will also be able to treat headache recurrence with the device Migraine headaches that are not treated with the device may be treated with usual care
The first reported treatment will be considered a training treatment aimed to verify that the participants use the device properly and will only be included in the safety analysis The efficacy evaluation will be performed on the first treatment of a qualifying attack see below following the training treatment hereby termed test treatment
Second final visit - End of study
Participants will return to the clinic following the end of the treatment phase at which time they will return the device The participants will have the option of returning the device by mail instead of an on-site visit
First visit - The first visit will include screening enrollment and training on the application and device
Treatment phase - Participants will be instructed to use the device for the treatment of qualifying migraine headaches see below as soon as possible and always within 60 minutes of onset during a period of up to 4 weeks Participants will be instructed to use the device with the intensity level identified during the device training visit and adjust as necessary and make sure the stimulation is perceptible but not painful Participants will be instructed to avoid taking rescue medications within 2 hours post-treatment If medications are used participants will be instructed to record in the app when and which medication was taken at 2- and 24-hours post treatment The participants will use the app to record pain intensity levels the presenceabsence of aura and associated migraine symptoms nausea photophobia phonophobia and allodynia l as well as rate their stress level and functional disability at baseline 2- and 24-hours post-treatment At the beginning of each treatment participants will also be asked to report the time elapsed from attack onset Adverse events will be reported throughout this phase of the study directly to the site staff
Participants who do not achieve satisfactory relief at 2 hours post-treatment may treat again with the Nerivio device or may treat with usual care at that time or any time thereafter if the headache does not resolve Participants will also be able to treat headache recurrence with the device Migraine headaches that are not treated with the device may be treated with usual care
The first reported treatment will be considered a training treatment aimed to verify that the participants use the device properly and will only be included in the safety analysis The efficacy evaluation will be performed on the first treatment of a qualifying attack see below following the training treatment hereby termed test treatment
Second final visit - End of study
Participants will return to the clinic following the end of the treatment phase at which time they will return the device The participants will have the option of returning the device by mail instead of an on-site visit
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