A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess STS101 in the Acute Treatment of Migraine

Key Inclusion Criteria:

• Males or females, 18-65 years of age at the time of Screening Visit
• Subject has at least 1-year history of migraines (with or without aura), according tothe International Classification of Headache Disorder, 3rd Edition (ICHD3)

Key Exclusion Criteria:

• Pregnant or breast-feeding women
• Women of child-bearing potential not using or not willing to use highly effectivecontraception.
• Diagnosis of headache conditions other than migraine with or without aura, includingdiagnosis of basilar or hemiplegic migraines or cluster headache.
• History of coronary artery disease, coronary artery vasospasm (includingPrintz-metals' angina), clinically significant arrhythmia or, peripheral vasculardisease, ischemic disease (e.g. Raynaud's syndrome, ischemic bowel syndrome, anginapectoris, myocardial infarction, or documented silent ischemia); percutaneous coronaryintervention, or cardiac surgery.
• History of cerebrovascular disease, including but not limited to stroke, transientischemic attack, cerebral hemorrhage, subarachnoid hemorrhage.
• Diagnosis of major depression with current symptoms, psychosis, alcohol abuse ordependence, drug abuse or dependence, major psychiatric conditions (e.g.schizophrenia, psychosis or Bipolar disorder), dementia. Other significantneurological or psychiatric disorders (including other pain syndromes or risk ofsuicide) that in the opinion of the investigator might interfere with studyparticipation and assessments or subject safety.
• Any clinically significant symptoms or conditions, including but not limited tocentral nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepaticor gastrointestinal conditions or history of such conditions that, in the opinion ofthe investigator might interfere with study assessments or safety of participant.