Status:
COMPLETED
Evaluation of a Novel Device for Treatment of Migraine Headache
Lead Sponsor:
Theranica
Collaborating Sponsors:
Rambam Health Care Campus
Northwell Health
Conditions:
Migraine Without Aura
Migraine With Aura
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. Recent eviden...
Detailed Description
Nerivio Migra is intended for the acute treatment of migraine with or without aura in patients 18 years of age or older. It is self-applied to the upper arm. Treatments are self-administered by the us...
Eligibility Criteria
Inclusion
- Subjects age 18-75 years old.
- Subjects meet the ICHD-3 diagnostic criteria for migraine with or without aura
- Subjects report 2-8 migraine attacks per month.
- Stable migraine preventive medications in the last two months prior to recruitment (No change in usage or dosage).
- Subjects must be able and willing to comply with the protocol
- Subjects must be able and willing to provide written informed consent
Exclusion
- Subject has other significant pain, medical or psychologic problems that in the opinion of the investigator may confound the study assessments
- Subject has an implanted electrical and/or neurostimulator device (e.g. cardiac pacemaker or defibrillator, vagus nerve neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator cochlear implant, Sphenopalatine ganglion stimulator or Occipital nerve stimulator).
- Subject has known uncontrolled epilepsy.
- Any use of Cannabis including medical use.
- Subject has \>10 headache days per month.
- Subject has undergone nerve block (occipital or other) in the head or neck within the last 2 weeks.
- Subject is participating in any other clinical study.
- The subject does not have the basic cognitive and motor skills needed to operate a smartphone.
- Pregnant, or trying to get pregnant
- Subject is experiencing a menstrually related migraine
- Received OnabotulinumtoxinA or any botulinum toxin injections for migraine within the previous month
- Received parenteral infusions for migraine within the previous 2 weeks.
- Subject participated in a previous study with the Nerivio Migra 1 device
Key Trial Info
Start Date :
December 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 25 2018
Estimated Enrollment :
296 Patients enrolled
Trial Details
Trial ID
NCT03361423
Start Date
December 17 2017
End Date
December 25 2018
Last Update
May 19 2021
Active Locations (12)
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1
Hartford Headache Center
Hartford, Connecticut, United States, 06107
2
Clinvest Research
Springfield, Missouri, United States, 65810
3
Mercy Hospital
St Louis, Missouri, United States, 63141
4
Clinical Reseach Consortium
Las Vegas, Nevada, United States, 89119