Migraine Treatment With Nerivio Migra Neurostimulation Device



Status:Terminated
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 75
Updated:5/11/2018
Start Date:April 2, 2017
End Date:April 1, 2018

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A Prospective, Randomized, Double-blind, Sham Controlled Multi-center Clinical Trial, Migraine Headache Treatment With Nerivio Migra Neurostimulation Device

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.


Inclusion Criteria:

1. Patient is 18-75 years old.

2. Patient meeting the ICHD-3 diagnostic criteria for migraine with and without aura.

3. Patients reporting 2-8 migraine attacks per month.

4. Patient must be able and willing to comply with the protocol.

5. Patient must be able and willing to provide written informed consent.

6. 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

Exclusion Criteria:

1. Has other significant pain problem that in the opinion of the investigator may
confound the study assessments

2. Is currently implanted with an 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).

3. Known uncontrolled epilepsy.

4. Use of Cannabis including medical use.

5. Has chronic migraine (more than 15 headache days per month).

6. Changed usage or dosage of migraine preventive medications in the last two months

7. Has undergone nerve block (occipital or other) in the head or neck within the last 2
weeks.

8. Is participating in any other clinical study. -
We found this trial at
5
sites
1 State Street
Hartford, New York 06103
Principal Investigator: Brian M Grosberg, MD
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47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
Principal Investigator: Charles Argoff, MD
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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Hadera, 38100
Principal Investigator: Yaron River, MD
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Hadera,
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450 Lakeville Road
New York, New York 11042
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New York, NY
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Washington, District of Columbia 20007
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Washington,
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