Table 1 Inclusion and exclusion criteria

ICHD-3-beta episodic migraine^a

Unable to distinguish migraine from other primary headache conditions

Onset of migraine before age 50

15 or more headache days per month

≥ 3-month history of 2–8 attacks/month; ≥ 75% of attacks progress to moderate or severe pain and/or nausea within 2 h (ie, rapidly-escalating)

Opioid usage > 10 days in the 30 days before screening

Acute headache medication on ≤ 14 days/month in the 3 months prior to enrollment

Use of MAO-A inhibitors within 28 days of randomization

No sumatriptan injections for ≥ 3 months

History of hemiplegic/basilar migraine; epileptogenic conditions; symptoms or signs of ischemic cardiac, cerebrovascular or peripheral vascular syndromes, or uncontrolled hypertension

If taking migraine prophylaxis, stable for 30 days before and throughout the study

Drug or alcohol abuse within the previous 2 years

Females: negative urine pregnancy test at screening, effective birth control, or surgically sterile or postmenopausal for ≥ 1 year before enrollment

Systemic disease or neurological or psychiatric condition^b

Willing to read and comprehend written instructions and internet access for electronic diary

Investigational medication ≤ 30 days before randomization

Sign informed consent document

Positive urine drug screen for recreational drugs, marijuana, or prescription drugs not explained by stated concomitant medications

Clinical laboratory or ECG abnormality

Fridericia’s corrected QT interval > 450 msec

Creatinine > 2 mg/dl; serum total bilirubin > 2.0 mg/dL

Serum AST, ALT, or alkaline phosphatase > 2.5 times ULN

Rebound headache from caffeine usage^b