| Eligibility |
Inclusion Criteria:
1. Written informed consent must be obtained from the subject in accordance with
requirements of the study site's Institutional Review Board (IRB) or ethics committee,
prior to initiation of any protocol-specified procedures.
2. Subject must be able to read.
3. Male or female subjects, 18 to 75 years of age inclusive.
4. Subject has at least a 1-year history of migraine (with or without aura) consistent
with a diagnosis according to ICHD (International Classification of Headache
Disorder), 3rd edition with the following:
- Age of onset prior to 50 years of age
- Migraine attacks lasting on average 4-72 hours untreated.
- By subject report at least 8 migraine days of moderate or severe intensity per
month over the previous 3 months (prior to screening)
- Ability to distinguish migraine from non-migraine headache.
- No more than 26 headache days of any type per month by subject report.
5. Patients with at least 8 qualified migraine days per month over the three months prior
to Screening will be eligible for entry into this study (assessed by historical
recall). A migraine attack must last at least 30 minutes. Any use of an acute
migraine-specific medication will count as a migraine attack (day). The interval
between two qualified migraine days should be at least 24 hours to be counted as
distinct migraine attacks. A migraine attack that remits following treatment (or
sleep) and recurs within 24 hours will be counted as one migraine attack.
6. Females should be either of non-childbearing potential by reason of surgery,
radiation, menopause (one year post onset), or of childbearing potential and
practicing a medically acceptable method of contraception (eg, abstinence, a barrier
method plus spermicide, or IUD) for at least one month before study participation and
for two months after the end of the study and have a negative urine B-hCG (Beta-human
chorionic gonadotropin) at Screening. Pregnant and/or lactating females are excluded.
Those women using hormonal contraceptives must also be using an additional approved
method of contraception (eg, a barrier method plus spermicide, or IUD) starting with
the Baseline Phase and continuing throughout the entire study period.
7. A sub-set of subjects (capped at 30% of total enrolled) on not more than 1 preventive
migraine medication may remain on therapy if the dose has been stable for at least 3
months (12 weeks) prior to the observation period and is not expected to change.
- Exceptions include onobotulinumtoxinA treatment (wash out = 4 months).
- Patients who are able and willing to attend study visits, maintain a headache
diary and otherwise comply with study related activities.
- Patients may be naive to botulinum neuro toxin (BoNT) therapy (no minimum or
cap), or have received BoNT therapy provided there is a 4-month washout period.
- A minimum of 30% of eligible subjects will be Chronic Migraine, per ICHD-3 (The
International Classification of Headache Disorder) criteria.
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 Internationals Headache
Society (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 calcitonin
gene-related peptide (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. Preexisting or current difficulties swallowing or breathing.
7. Known or suspected serious neuromuscular, or cardiovascular disorder (such as
amyotrophic lateral sclerosis, myasthenia gravis, coronary artery disease). that in
the opinion of the investigator would place the participant at increased risk of an
adverse event.
8. 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.
9. 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.
10. 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.
11. Body mass index of <18 or >35.
12. Patients who within the past 3 years have a history of or have been treated for
alcohol or drug abuse.
13. Women who are unwilling or unable to use acceptable contraception during the study.
14. Women who are pregnant or breastfeeding.
15. 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.
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