A Prospective, Randomized, Double-blind, Sham Controlled Multi-center Clinical Trial, Migraine Headache Treatment With Nerivio Migra Neurostimulation Device
Status: Terminated
Location: See all (8) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This is a prospective, randomized, double-blind, sham controlled multi-center trial. Ratio between treatment and control groups will be 1:1, stratified by center and use of preventive medications.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Patient is 18-75 years old.
• Patient meeting the ICHD-3 diagnostic criteria for migraine with and without aura.
• Patients reporting 2-8 migraine attacks per month.
• Patient must be able and willing to comply with the protocol.
• Patient must be able and willing to provide written informed consent.
• Male or non-pregnant / non-lactating female (NOTE: Females of child bearing potential must have a negative pregnancy test) and must be willing to use adequate contraceptive means during the study
Locations
United States
Washington, D.c.
MedStar - Georgetown University Hospital
Washington
New York
Albany Medical College
Albany
Hartford Healthcare Headache Center
Hartford
Northwell Health, Inc
New York
Other Locations
Israel
Hillel Yaffe Medical Center
Hadera
Herzeliya medical Center
Herzliya
Maccabi Healthcare neurology clinics
Kefar Saba
Western Galilee Medical Center
Nahariya
Time Frame
Start Date: 2017-04-02
Completion Date: 2018-04-01
Participants
Target number of participants: 120
Treatments
Active_comparator: Nerivio Migra active
This arm will use the active device for acute treatment of migraine at the migraine symptoms onset. the device will be applied on the upper arm and controlled by a dedicated smartphone application.
Sham_comparator: Nerivio Migra placebo
This arm will use the sham device for acute treatment of migraine at the migraine symptoms onset. the device will be applied on the upper arm and controlled by a dedicated smartphone application.
Authors
Related Therapeutic Areas
Sponsors
Leads: Theranica