Clinical trial NCT03912337: Effect of Erenumab-aooe on Disability and Work Productivity in Employed Subjects With Episodic Migraine
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Migraine
Keywords: Episodic migraine
Disability
Migraine-related disability
Work productivity
Erenumab
AIMOVIG
Lead sponsor: Amgen
Sponsor class: INDUSTRY
Collaborators: name: Novartis
First posted: 2019-04-11
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.

Primary outcomes:
measure: Sum of Monthly Changes From Baseline in Modified MIDAS Total Score Over the 6-month DBTP
timeFrame: Baseline and Months 1 to 6
Secondary outcomes:
measure: Change From Baseline in Mean MMD Over Months 4, 5, and 6 of the 6-month DBTP
timeFrame: Baseline and the last 3 months (months 4, 5, and 6) of the 6-month DBTP
measure: Change From Baseline in Mean Monthly Percent Work Impairment Over Months 4, 5, and 6 of the 6-month DBTP
timeFrame: Baseline and the last 3 months (months 4, 5, and 6) of the 6-month DBTP
measure: Change From Baseline in Mean MFIQ Physical Functioning Domain Score Over Months 4, 5, and 6 of the 6-month DBTP
timeFrame: Baseline and the last 3 months (months 4, 5, and 6) of the 6-month DBTP
measure: Change From Baseline in Mean MFIQ Usual Activities Domain Score Over Months 4, 5, and 6 of the 6-month DBTP
timeFrame: Baseline and the last 3 months (months 4, 5, and 6) of the 6-month DBTP
measure: Change From Baseline in Mean MFIQ Social Functioning Domain Score Over Months 4, 5, and 6 of the 6-month DBTP
timeFrame: Baseline and the last 3 months (months 4, 5, and 6) of the 6-month DBTP
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Huntsville
country: United States
facility: Research Site
state: Alabama
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Pasadena
country: United States
facility: Research Site
state: California
city: Basalt
country: United States
facility: Research Site
state: Colorado
city: East Hartford
country: United States
facility: Research Site
state: Connecticut
city: New London
country: United States
facility: Research Site
state: Connecticut
city: Stamford
country: United States
facility: Research Site
state: Connecticut
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Chalmette
country: United States
facility: Research Site
state: Louisiana
city: Hagerstown
country: United States
facility: Research Site
state: Maryland
city: Worcester
country: United States
facility: Research Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Research Site
state: Michigan
city: Minneapolis
country: United States
facility: Research Site
state: Minnesota
city: Bolivar
country: United States
facility: Research Site
state: Missouri
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Saint Peters
country: United States
facility: Research Site
state: Missouri
city: Springfield
country: United States
facility: Research Site
state: Missouri
city: Toms River
country: United States
facility: Research Site
state: New Jersey
city: Durham
country: United States
facility: Research Site
state: North Carolina
city: Greensboro
country: United States
facility: Research Site
state: North Carolina
city: Centerville
country: United States
facility: Research Site
state: Ohio
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Austin
country: United States
facility: Research Site
state: Texas
city: Frisco
country: United States
facility: Research Site
state: Texas
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: