Efficacy of Erenumab on Functional Impact of Migraine

Exclusion Criteria

• •Participants are excluded from the study if any of the following criteria apply:
• •1. unable to understand the study requirements, the informed consent, or complete headache records as required per protocol;
• •2. pregnant, actively trying to become pregnant, or breast-feeding;
• •3. history of substance abuse and/or dependence, in the opinion of the Investigator;
• •4. history of impaired renal function that, in the investigator's opinion, contraindicates participation in this study;
• •5. suffers from a serious illness, or an unstable medical condition, one that could require hospitalization, or could increase the risk of adverse events;
• •6. a psychiatric condition, in the opinion of the investigator, that may affect the interpretation of efficacy and safety data or contraindicates the participant's participation in the study;
• •7. received nerve blocks or trigger point injections in the previous 8 weeks or plans to receive them during the study;
• •8. prior exposure in the last 6 months to biologics or drugs specifically targeting the calcitonin gene-related peptide (CGRP) pathway;
• •9. has failed more than 3 classes of medications for the prevention of migraine, or \>6 migraine preventative medications of any type due to lack of efficacy;
• •10. received any investigational agents within 30 days prior to Visit 1 (6 months for any investigational biological products unless previous study blind has been broken and subject was known to have received placebo);
• •11. plans to participate in another clinical study at any time during this study;
• •12. history of medication overuse of opioids or butalbital, as defined by opioid or butalbital use ≥10 days/month in previous 12 months or during run-in period; Medication Overuse Headache (MOH) with other medication types will be allowed but must be documented;
• •13. unstable medication use for migraine prevention (changes in the last 3 months);
• •14. clinically relevant lab results at screening as determine by the investigator;
• •15. clinically relevant or significant ECG abnormalities as determine by the investigator, including ECG with QT interval corrected for heart rate (QTc) using Fridericia's correction formula (QTcF) \> 500 msec;
• •16. history of any of the following cardiovascular conditions:
• •1. Moderate to severe congestive heart failure (New York Heart Association class III or IV);
• •2. Recent (within past 12 months) cerebrovascular accident, myocardial infarction, coronary stenting;
• •3. Uncontrolled hypertension as defined by a confirmed systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg.
• •17. active HIV or Hepatitis C infection;
• •18. allergy to latex;
• •19. score of \> 0 on question 9 on Patient Health Questionnaire (PHQ-9) at any visit;
• •20. have any other condition, that in the judgment of the investigator, would make the participant unsuitable for inclusion, or would interfere with the participant participating in or completing the study.