Open Label, 6-month Study for High Frequency and Chronic Migraine,

Exclusion Criteria

• •1. Migraine patients with ≥26 headache days of any kind per month by historical report over the 3 months prior to study.
• •2. Patients with cluster headaches and other trigeminal autonomic cephalalgias, and other primary headaches (except tension-type headache) and secondary headaches (defined according to the Headache Classification Committee of the IHS, 3rd Edition, 2018),
• •3. Patients with a history of being non-responsive to adequate trials of more than two classes of migraine preventive treatments (e.g., beta blockers, calcium channel blockers, tricyclics, divalproex, topiramate, small or large molecule CGRP antagonists or onobotulinumtoxinA).
• •4. Patients who use the following medications as described:
• •* Use of triptans, ditans or ergot-containing medications for 10 days or greater per month on average,
• •* Use of NSAIDs, acetaminophen or combination analgesics (such as acetaminophen-caffeine products) 15 days or greater per month on average,
• •* Use of opioids and/or butalbital containing medications for 4 days or greater per month on average,
• •* Use of any two or more of the above medications (excluding opioids/butalbital) for 15 days or greater per month on average.
• •5. Patients with clinically significant neurological illness, other than migraine, that, in the opinion of the Investigators, may have the potential of altering pain perception or reporting,
• •6. Known or suspected serious neuromuscular, respiratory or cardiovascular disorder (such as amyotrophic lateral sclerosis, myasthenia gravis, severe chronic obstructive pulmonary disorder, coronary artery disease) that in the opinion of the investigator would place the participant at increased risk of an adverse event.
• •7. Patients with a history of or currently having major psychiatric disorders including schizophrenia, active psychosis or bipolar disorder. Major depressive disorder and generalized anxiety disorder which, in the investigator's opinion are well-controlled, will be allowed.
• •8. Patients with clinically significant active hepatic disease, cardiovascular, metabolic, respiratory, renal, endocrinological (including poorly controlled diabetes mellitus), gastrointestinal diseases, and bacterial or viral infections within 30 days prior to Screening or during the Baseline Phase, that in the opinion of the investigator may interfere with subject's participation in the study or may present a risk of the subject not completing the study.
• •9. Patients with hematologic or solid malignancy diagnosis within 5 years prior to screening with the exception of basal cell carcinoma and squamous cell carcinoma if they have been cancer free prior to screening.
• •10. Body mass index of \<18 or \>35.
• •11. Patients who within the past 3 years have a history of or have been treated for alcohol or drug abuse.
• •12. Women who are unwilling or unable to use acceptable contraception during the study.
• •13. Women who are pregnant or breastfeeding.
• •14. Patients who have participated in a drug intervention study for any indication within 60 days (or 5 half-lives of the investigational drug, whichever is longer) or non-drug intervention study (such as electrical stimulation) within 30 days.