Inclusion criteria:
Patients are 18 to 60 years of age (inclusive) at the time of signing the informed consent form
Have a diagnosis of migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD-3 2018) (migraine with or without aura), with a history of migraine of at least 1 year prior to screening, and migraine onset prior to age 50
Prior to screening, have a history of at least 4 migraine headache days and at least 1 headache-free day per month on average within the past 3 months
Prior to screening, have previous failure to 2 to 4 migraine preventive medication categories in the past 10 years from the following list: a) propranolol or metoprolol, b) topiramate, c) valproate or divalproex, d) amitriptyline or nortriptyline, e) venlafaxine or duloxetine, f) flunarizine, g) botulinum toxin A or B
During prospective baseline period, have a frequency of 4 or more migraine headache days and at least 1 headache-free day in the 30-day run-in period
Ability to comprehend and willingness to sign the informed consent form for this study and adherence to the study protocol principles
Exclusion criteria:
Treatment with any investigational agent in the last 30 days prior to screening visit or passing less than five half-lives of the investigational agent (whichever is longer) or participating in clinical studies consisting of any investigational agent or procedure
Prior exposure to Galcanezumab or another CGRP (Calcitonin gene-related peptide) antibody
Have a history of known serious allergies to any components of the formulation
Receiving more than one medication or other treatments for the prevention of migraine in the run-in visit. Patients must have discontinued such treatment(s) at least 30 days prior to entering the run-in period. Botulinum toxin A and B that has been administered in the head or neck area for therapeutic use must be discontinued at least 3 months prior to entering the run-in period.
Failure to respond to more than 4 migraine preventive medication categories from the list in Inclusion Criterion [4]. Previous failures to medications not on the above list will not count toward this exclusion.
History of other types of headaches besides migraine, tension type headache, or medication overuse headache (MOH) as defined by IHS ICHD-3 in the 3 months prior to randomization (In other words, patients can have migraine, tension type headache, or MOH in the 3 months prior to randomization, but they cannot have other types of headaches in that time.)
History of cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine) defined by IHS ICHD-3
History of head or neck injury within 6 months prior to screening
History of traumatic head injury associated with a significant change in the quality or frequency of headaches
History of myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft, deep vein thrombosis/pulmonary embolism, or stroke within 6 months of screening, or have planned cardiovascular surgery or percutaneous coronary intervention
Patients who have used opioids or barbiturate >4 days per month for the treatment of pain in more than 2 of the past 3 months
Alanine aminotransferase (ALT) >3-fold upper limit of normal (ULN), or total bilirubin (TBL) >2-fold ULN, or alkaline phosphatase (ALP) >3-fold ULN at the screening visit
History of significant psychiatric disease, such as bipolar disorder, schizophrenia, personality disorders, or other serious mood or anxiety disorders. Note: Patients with major depressive disorder (MDD) or generalized anxiety disorder (GAD) whose disease state is considered stable and expected to remain stable throughout the course of the study, in the opinion of the investigator, may be considered for inclusion if they are not on excluded medications.
Women who are pregnant, nursing, or planning a pregnancy during the study
History of drug or alcohol abuse/dependence within 1 year prior to screening judged by the investigator
Having any other condition such as major neurologic diseases which, in the opinion of the investigator, will make the subject inappropriate for enrolling the study