Effect of Erenumab-aooe on Disability and Work Productivity in Employed Subjects With Episodic Migraine
NCT ID: NCT03912337
Last Updated: 2022-07-20
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
29 participants
INTERVENTIONAL
2019-12-04
2021-07-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Placebo
After subjects complete baseline and are found eligible, they will be enrolled and randomized in a 1:1 ratio to either erenumab or placebo.
Placebo
Placebo once every 4 weeks. SC injection.
Erenumab
After subjects complete baseline and are found eligible, they will be enrolled and randomized in a 1:1 ratio to either erenumab or placebo.
Erenumab
Erenumab once every 4 weeks. SC injection.
Interventions
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Placebo
Placebo once every 4 weeks. SC injection.
Erenumab
Erenumab once every 4 weeks. SC injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
99 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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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
Research Site
Austin, Texas, United States
Research Site
Frisco, Texas, United States
Research Site
Salt Lake City, Utah, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20180060
Identifier Type: -
Identifier Source: org_study_id
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