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

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Migraine

In brief

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.

Key facts

Study ID: NCT03912337
Run by: Amgen
People needed: 29
Starts: 2019-12-04
Expected to finish: 2021-07-28
Last updated by the study team: 2022-07-20

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

Research Site — Birmingham, Alabama, United States
Research Site — Huntsville, Alabama, United States
Research Site — Los Angeles, California, United States
Research Site — Pasadena, California, United States
Research Site — Basalt, Colorado, United States
Research Site — East Hartford, Connecticut, United States
Research Site — New London, Connecticut, United States
Research Site — Stamford, Connecticut, United States
Research Site — Jacksonville, Florida, United States
Research Site — Orlando, Florida, United States
Research Site — Chalmette, Louisiana, United States
Research Site — Hagerstown, Maryland, United States
Research Site — Worcester, Massachusetts, United States
Research Site — Ann Arbor, Michigan, United States
Research Site — Minneapolis, Minnesota, United States
Research Site — Bolivar, Missouri, United States
Research Site — City of Saint Peters, Missouri, United States
Research Site — Springfield, Missouri, United States
Research Site — St Louis, Missouri, United States
Research Site — Toms River, New Jersey, United States
Research Site — Durham, North Carolina, United States
Research Site — Greensboro, North Carolina, United States
Research Site — Centerville, Ohio, United States
Research Site — Philadelphia, Pennsylvania, United States
Research Site — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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