Migraine Clinical Trials

• Participants are eligible to be included in this study only if all of the following criteria apply:

• Age and Reproductive Status:

• 18 years of age or older who meet the reproductive criteria.

• Disease Characteristics:

• Participant has at least a 1-year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following:

‣ At least 5 attacks fulfilling criteria 1-3:

⁃ Headache attacks lasting 4-72 hours (when untreated or unsuccessfully treated).

• Headache has at least 2 of the following 4 characteristics:

∙ Unilateral location

‣ Pulsating quality

‣ Moderate or severe pain intensity

‣ Aggravation by or causing avoidance of routine physical activity (eg, walking or climbing stairs)

• During headache, at least 1 of the following:

‣ Nausea and/or vomiting

‣ Photophobia and phonophobia

⁃ Not better accounted for by another ICHD-3 diagnosis.

• Participants experience 4-14 migraine days / month and fewer than 7 non-migraine headache days / month on average and overall, less than 15 days with headache (migraine or non-migraine) per month across the 3 months prior to screening.

• Participants on prophylactic migraine medication (non-CGRP) are permitted to remain on therapy if they have been on a stable dose for at least 3 months prior to screening visit, and the dose is not expected to change during the study.

• Participants have previous insufficient response and/or prior intolerance to at least one triptan or documented contraindication to the use of triptan.

‣ Insufficient response - Previous treatment with one or more triptan has yielded no, unsatisfactory or inconsistent therapeutic effect (eg, recurrent, incomplete relief of migraine related symptoms \[including pain, nausea, photophobia, phonophobia etc\] at 2 hours post dose, non-sustained relief of migraine related symptoms through 24 hours post dose, etc), after repeated dosing (≥2 attempts) at recommended dose level.

⁃ Prior intolerance - treatment with triptan has been interrupted because of an adverse event that made continuation of the drug intolerable for the individual.

∙ Prior triptan associated overuse headache

∙ Arrhythmia associated with prior triptan use

∙ Chest/throat/neck/jaw pain, tightness, pressure or heaviness associated with prior use of triptan

∙ Gastrointestinal ischemia or peripheral vasospastic reaction associated with prior use of triptan

∙ Serotonin syndrome associated with prior triptan use

⁃ Documented contraindication to triptans -

⁃ Documented hypersensitivity to triptan

• Cardiovascular events, conditions and procedures considered contraindications to the use of triptan medications.

• i. Events: Myocardial infractions, prior cardiac arrest, transient ischemic attack, cerebrovascular accident (Intracerebral haemorrhage, intracranial haemorrhage, subarachnoid haemorrhage, ischemic stroke) ii. Conditions: Angina pectoris, coronary artery vasospasm, ischemic coronary artery disease, peripheral artery disease, ischemic bowel disease, cardiac conduction disorders (life threatening arrhythmia/heart block) iii. Procedure: Angioplasty, coronary artery bypass grafting, carotid endarterectomy 3) Uncontrolled hypertension