Status:
COMPLETED
Assessment of Safety and Efficacy of Nerivio for the Migraine Prevention
Lead Sponsor:
Theranica
Conditions:
Migraine
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Migraine is a common neurologic with attacks of headache and associated symptoms such as nausea, vomiting, phono and photophobia. Migraine can lead to substantial functional impairment. This study int...
Detailed Description
Nerivio is a neuromodulation device approved for the acute treatment of migraine with or without aura in patients 12 years of age or older. The device utilizes electro stimulation to achieve condition...
Eligibility Criteria
Inclusion
- Age 18-75 years old.
- Must have at least a 6-month history of headaches that meet the ICHD-3 diagnostic criteria for migraine with or without aura, either chronic (at least 15 days of Headache Days(HD)/ month with migraine days (migraine with or without aura) at least 8 days/ month for \> 3 months) or non-chronic migraine.
- History of 6 to 24 headache days per 28-day period for each of the 3 months preceding study enrolment (based on participant report).
- Subject on prophylactic migraine treatment are permitted to remain on 1 medication with possible migraine-prophylactic effects if the dose has been stable for at least 2 months prior to the screening visit, and the dose is not expected to change during the course of the study.
- Have personal access to a smartphone (24/7).
- Must be able and willing to comply with the protocol.
- Must be able and willing to provide informed consent..
Exclusion
- An active implanted electrical and/or neurostimulator device (e.g. cardiac pacemaker, cochlear implant).
- Uncontrolled epilepsy.
- History of use of opioids or barbiturates on more than 4 days a month in the last 6 months.
- Current participation in any other interventional clinical study
- Subject without basic cognitive and motor skills required for operating a smartphone.
- Pregnant or breastfeeding.
- Other significant pain, medical or psychological problems that in the opinion of the investigator may confound the study assessments.
- Prior experience with the Nerivio device.
Key Trial Info
Start Date :
April 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2022
Estimated Enrollment :
335 Patients enrolled
Trial Details
Trial ID
NCT04828707
Start Date
April 13 2021
End Date
October 10 2022
Last Update
March 15 2023
Active Locations (16)
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1
Evolve Clinical Research
Phoenix, Arizona, United States, 85013
2
The Neurology Center of Southern California
Carlsbad, California, United States, 92011
3
Newport Beach Clinical Research Associates
Newport Beach, California, United States, 92663
4
Hartford Headache Center
Hartford, Connecticut, United States, 06107