effect of erenumab-aooe on disability and work productivity in employed subjects with episodic migraine

Conditions: Migraine

Summary: 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.

Eligibility criteria:
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.

Keywords: episodic migraine disability migraine-related disability work productivity erenumab aimovig