Effect of Erenumab-aooe on Disability and Work Productivity in Employed Subjects With Episodic Migraine
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ClinicalTrials.gov Identifier: NCT03912337 |
Recruitment Status :
Recruiting
First Posted : April 11, 2019
Last Update Posted : December 31, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Migraine | Drug: Placebo Drug: Erenumab | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 340 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
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. |
Actual Study Start Date : | December 4, 2019 |
Estimated Primary Completion Date : | November 25, 2022 |
Estimated Study Completion Date : | November 25, 2022 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: 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.
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Drug: Placebo
Placebo once every 4 weeks. SC injection. |
Experimental: 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.
|
Drug: Erenumab
Erenumab once every 4 weeks. SC injection.
Other Name: Aimovig |
- Sum of monthly changes from baseline in modified Migraine Disability Assessment (MIDAS) [ Time Frame: Entire 6-month double-blind period ]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.
- Change from baseline in mean monthly migraine days (MMD) [ Time Frame: Months 4, 5, and 6 ]To evaluate the effect of erenumab compared to placebo on monthly migraine days (MMD) in employed subjects with EM who have previously failed 1 or more migraine preventive treatments.
- Change from baseline in mean monthly percent work impairment [ Time Frame: Months 4, 5 and 6 ]To evaluate the effect of erenumab compared to placebo on work impairment in employed subjects with EM who have previously failed 1 or more migraine preventive treatments.
- Change from baseline in mean physical function [ Time Frame: Months 4, 5, and 6 ]To evaluate the effect of erenumab compared to placebo on physical function in employed subjects with EM who have previously failed 1 or more migraine preventive treatments.
- Change from baseline in mean usual activities [ Time Frame: Months 4, 5 and 6 ]To evaluate the effect of erenumab compared to placebo on usual activities in employed subjects with EM who have previously failed 1 or more migraine preventive treatments.
- Change from baseline in mean social function [ Time Frame: Months 4, 5, and 6 ]To evaluate the effect of erenumab compared to placebo on social function in employed subjects with EM who have previously failed 1 or more migraine preventive treatments.

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912337
Contact: Amgen Call Center | 866-572-6436 | medinfo@amgen.com |
United States, Alabama | |
Research Site | Recruiting |
Birmingham, Alabama, United States, 35235 | |
Research Site | Recruiting |
Huntsville, Alabama, United States, 35805 | |
United States, California | |
Research Site | Recruiting |
Los Angeles, California, United States, 90094 | |
Research Site | Recruiting |
Pasadena, California, United States, 91105 | |
United States, Colorado | |
Research Site | Recruiting |
Basalt, Colorado, United States, 81621 | |
United States, Connecticut | |
Research Site | Completed |
East Hartford, Connecticut, United States, 06118 | |
Research Site | Recruiting |
New London, Connecticut, United States, 06320 | |
Research Site | Recruiting |
Stamford, Connecticut, United States, 06905 | |
United States, Florida | |
Research Site | Recruiting |
Jacksonville, Florida, United States, 32216 | |
Research Site | Recruiting |
Orlando, Florida, United States, 32806 | |
United States, Louisiana | |
Research Site | Recruiting |
Chalmette, Louisiana, United States, 70043 | |
United States, Maryland | |
Research Site | Recruiting |
Hagerstown, Maryland, United States, 21742 | |
United States, Massachusetts | |
Research Site | Recruiting |
Worcester, Massachusetts, United States, 01605 | |
United States, Michigan | |
Research Site | Recruiting |
Ann Arbor, Michigan, United States, 48104 | |
United States, Minnesota | |
Research Site | Recruiting |
Minneapolis, Minnesota, United States, 55402 | |
United States, Missouri | |
Research Site | Recruiting |
Bolivar, Missouri, United States, 65613 | |
Research Site | Recruiting |
Saint Louis, Missouri, United States, 63141 | |
Research Site | Recruiting |
Saint Peters, Missouri, United States, 63303 | |
Research Site | Recruiting |
Springfield, Missouri, United States, 65810 | |
United States, New Jersey | |
Research Site | Recruiting |
Toms River, New Jersey, United States, 08755 | |
United States, North Carolina | |
Research Site | Recruiting |
Durham, North Carolina, United States, 27713 | |
Research Site | Recruiting |
Greensboro, North Carolina, United States, 27405 | |
United States, Ohio | |
Research Site | Recruiting |
Centerville, Ohio, United States, 45459 | |
United States, Pennsylvania | |
Research Site | Recruiting |
Philadelphia, Pennsylvania, United States, 19107 | |
United States, Tennessee | |
Research Site | Completed |
Nashville, Tennessee, United States, 37203 | |
United States, Texas | |
Research Site | Recruiting |
Austin, Texas, United States, 78731 | |
Research Site | Recruiting |
Frisco, Texas, United States, 75034 | |
United States, Utah | |
Research Site | Recruiting |
Salt Lake City, Utah, United States, 84109 |
Study Director: | MD | Amgen |
Responsible Party: | Amgen |
ClinicalTrials.gov Identifier: | NCT03912337 |
Other Study ID Numbers: |
20180060 |
First Posted: | April 11, 2019 Key Record Dates |
Last Update Posted: | December 31, 2020 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) |
Time Frame: | Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study. |
Access Criteria: | Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below. |
URL: | https://www.amgen.com/datasharing |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Episodic migraine Disability Migraine-related disability |
Work productivity Erenumab AIMOVIG |
Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Erenumab |
Calcitonin Gene-Related Peptide Receptor Antagonists Molecular Mechanisms of Pharmacological Action Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |