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Effect of Erenumab-aooe on Disability and Work Productivity in Employed Subjects With Episodic Migraine | Clinical Trials | Clareo Health

TERMINATEDPHASE4

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.

NCT03912337•Amgen

View on ClinicalTrials.gov

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.

Detailed Description

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

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

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

Locations (28)

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

Key Dates

Start Date

December 4, 2019

Primary Completion Date

July 28, 2021

Completion Date

July 28, 2021

Last Updated

July 20, 2022

Enrollment

ACTUAL participants

Conditions

Migraine

Interventions

Placebo

DRUG

Erenumab

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 20, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine

Mind Body Balance for Pediatric Migraine

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A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine

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