Migraine - Observational Study
Non interventional study for migraine preventive standard of care in adult patients
Migraine is a common disabling primary headache disorder. In addition to the pain of migraine attacks and burdensome symptoms, migraine has a significant impact on patient's health-related quality of life, including physical, emotional, and social aspects of daily living, and effects on family, work, and social relationships. Globally, migraine is ranked second as a cause of disability expressed as years lived with disability. The etiology of migraine is not clear, but likely includes both genetic and environmental components.
TARGET PATIENTSPatients who are switching or initiating preventive treatment
STAGE OF THE STUDYPhase 1
Primary Objective of the Study
The primary objective of this multi-country non interventional study is to compare the effectiveness of galcanezumab to oral migraine preventive standard of care overall in adult patients with migraine who are switching or initiating preventive treatment in clinical practice settings.
Specifically, this will estimate the proportion of patients in the longitudinal follow-up who achieve a clinically meaningful reduction from baseline in monthly migraine headache daysat Month 3. Migraine headache days will be determined based on criteria evaluated from patient headache diary entries.
Clinically meaningful will be defined as:≥50% reduction from baseline at Month 3 for episodic migraine>30% reduction from baseline at Month 3 for chronic migraine
Selected Inclusion Criteria
1. A diagnosis of migraine, with or without aura, or chronic migraine, as determined by the study investigator and in consideration of International Headache Society International Classification of Headache Disorders - 3rd edition guidelines (ICHD-3 2018).
2. Under the care of the study investigator prior to entering the study or the study investigator will be providing routine migraine care throughout the duration of the study.
3. Able to reliably report on historical details regarding frequency of monthly migraine headache days during the past month, in the opinion of the study investigator.
4. Switching or initiating a new pharmacologic migraine preventive treatment within the usual course of care and according to the approved label in the respective country. Note that:● The initiating treatment cannot be one that has been taken by the patient in the prior 12 months.● Concurrent migraine preventive treatment, including pharmacological, nonpharmacological, and any over-the-counter supplement taken specifically for migraine prevention, is allowed, provided the existing treatment (s) has (have) been at a stable dose for at least 3 months prior to entry. For concurrent nonpharmacological treatment, the regimen must have been stable for at least 3 months prior to entry.
5. Adult patients ≥18 years of age and in accordance with country-specific requirements.
6. Able to provide written informed consent as approved by Eli Lilly and Company (Lilly) or its designee, and the Investigational Review Board/Ethical Review Board governingthe site and/ or study.
7. Sufficient literacy in the local language and cognitively able to understand and complete patient self-rated questionnaires.
8. Access to internet or personal device for completion of patient self-rated questionnaires and diary. The personal device must meet requirements for the eCOA platform
Selected Exclusion Criteria
1. Are investigator site personnel directly affiliated with the study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
2. Are Lilly employees.
3. Are terminally ill.
4. Are participating in another study that includes treatment with an investigational drug and/or intervention at the same time as enrollment in the current study.
5. Do not initiate the index preventive treatment within 56 days of the baseline visit or treatment assignment.