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

Phase 4TerminatedNCT03912337

Amgen29 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Migraine

Interventions

PlaceboDRUG

Placebo once every 4 weeks. SC injection.

ErenumabDRUG

Erenumab once every 4 weeks. SC injection.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (28)

Research Site

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Sum of Monthly Changes From Baseline in Modified MIDAS Total Score Over the 6-month DBTP

The modified MIDAS Questionnaire is a 5-item questionnaire that measures headache-related disability as lost time from paid work or school, housework, and non-work (family, social, and leisure) activities. Participants provided the number of productive days lost or productivity reduced by half or more over the past month due to headache (item score range from 0 to 31). Productive days lost counted in items 1 and 3 were not included for items 2 and 4, respectively. The 5 item scores were summed to calculate the MIDAS total score (range from 0 to 93). The change from baseline was calculated by subtracting the baseline total score from the total score calculated each month. The change from baseline values for Months 1 to 6 were then summed to calculate the sum of monthly changes from baseline (range from -558 to 558). A negative sum of changes from baseline indicated a better outcome.

Time frame: Baseline and Months 1 to 6

Secondary Outcomes

Change From Baseline in Mean MMD Over Months 4, 5, and 6 of the 6-month DBTP

A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache) or received migraine-specific medication during aura. A qualified migraine headache was defined either as a migraine (≥30 minutes) with or without aura. The change from baseline in monthly migraine days was calculated as the average number of migraine days per month during the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase subtract the number of migraine days during the 4-week baseline phase. A negative change from baseline indicates a better outcome.

Time frame: Baseline and the last 3 months (months 4, 5, and 6) of the 6-month DBTP

Change From Baseline in Mean Monthly Percent Work Impairment Over Months 4, 5, and 6 of the 6-month DBTP

Percent work impairment was calculated based on questions 2, 4 and 5 of the Work Productivity and Activity Impairment (WPAI) Migraine-Questionnaire and could range from 0% to 100%. The questionnaire was collected weekly. The monthly percent work impairment was equal to the arithmetic mean of the observed weekly percent work impairment over the monthly interval. Higher scores indicate greater impairment. Change from baseline in mean monthly percent work impairment was calculated as the average of monthly percent work impairment over the last 3 months (month 4, 5, and 6) of the 24-week double-blind treatment phase minus the baseline score. A negative change from baseline indicates a better outcome.

Data from ClinicalTrials.gov

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