Effect of Erenumab-aooe on Disability and Work Productivity in Employed Subjects With Episodic Migraine

Effect of Erenumab-aooe on Disability and Work Productivity in Employed Subjects With Episodic Migraine Who Have Previously Failed 1 or More Migraine Preventive Treatments.

To evaluate the effect of erenumab compared to placebo on disability in employed subjects with episodic migraine (EM) who have previously failed 1 or more migraine preventive treatments.

Migraine prevention continues to be an area of large, unmet medical need, with existing therapies often having modest efficacy and poor tolerability. Calcitonin gene-related peptide (CGRP) has an important role in the pathophysiology of migraine. Erenumab-aooe is a fully human monoclonal antibody that targets the CGRP receptor, and interrupts its downstream effects. Erenumab has been approved for the preventive treatment of migraine in adults. The present study is a Phase IV trial that will assess the effect of erenumab on disability and work productivity in employed subjects with episodic migraine (EM) who have previously failed 1 or more migraine preventive treatments.

Inclusion Criteria:

• Greater than or equal to 18 years of age upon entry into screening.
• Documented history of migraine with or without aura according to the IHS ICHD-III for greater than or equal to 12 months
• Has EM defined as history of greater than or equal to 4 and less than 15 migraine days and less than 15 headache days per month on average during the 3 months prior to initial screening
• Employed greater than or equal to 20 hours/week upon entry into initial screening, stable for at least 3 months in the same job and has not specified willful termination of employment throughout the duration of the study. Employment is defined by work outside the home, self-employed, or works from home
• Has greater than or equal to 4 hours of lost productive time due to headache/migraine and/or related symptoms in the past month prior to initial screening as determined by subject
• Has total disability score of greater than 10 as assessed by MIDAS (3-month recall) at initial screening
• History of treatment failure with at least 1 preventive treatment category for migraine

Exclusion Criteria:

• Older than 50 years of age at migraine onset
• History of cluster headache, hemiplegic migraine, or other trigeminal autonomic cephalalgia.
• Taken an opioid and/or opioid-containing analgesic greater than or equal to 4 days during the 1 month prior to screening for any indication
• Taken a butalbital and/or butalbital-containing analgesic greater than or equal to 4 days during the 1 month prior to screening for any indication
• Change in the regimen of current migraine preventive treatment or a concomitant medication that may have migraine prevention effects during baseline
• Taken an opioid and/or opioid-containing analgesic ≥ 4 days during baseline for any indication.
• Taken a butalbital and/or butalbital-containing analgesic ≥ 4 days during baseline for any indication.
• Previously treated with any agent (monoclonal antibody or small molecule) targeting the CGRP pathway (ligand or receptor) in preventive settings

Other inclusion and exclusion criteria may apply.