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

• Status: Terminated
• Trial end date: 2021-07-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Collaborator: Novartis
• Treatments: Antibodies, Monoclonal; Erenumab

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.