Trial record 1 of 12 for: amgen | Missouri, United States | Phase 4

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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 : Terminated (Terminated [Study would not complete enrollment target until 2026 with results available in 2027. The information will not be useful at that time.])

First Posted : April 11, 2019

Results First Posted : July 20, 2022

Last Update Posted : July 20, 2022

View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborator:

Novartis

Information provided by (Responsible Party):

Amgen

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Migraine	Drug: Placebo Drug: Erenumab	Phase 4

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	29 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
Actual Primary Completion Date :	July 28, 2021
Actual Study Completion Date :	July 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine

MedlinePlus related topics: Migraine

Drug Information available for: Erenumab

U.S. FDA Resources

Arms and Interventions

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.	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

Outcome Measures

Primary Outcome Measures :

Sum of Monthly Changes From Baseline in Modified MIDAS Total Score Over the 6-month DBTP [ Time Frame: Baseline and Months 1 to 6 ]
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.

Secondary Outcome Measures :

Change From Baseline in Mean MMD Over Months 4, 5, and 6 of the 6-month DBTP [ Time Frame: Baseline and the last 3 months (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.
Change From Baseline in Mean Monthly Percent Work Impairment Over Months 4, 5, and 6 of the 6-month DBTP [ Time Frame: Baseline and the last 3 months (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.
Change From Baseline in Mean MFIQ Physical Functioning Domain Score Over Months 4, 5, and 6 of the 6-month DBTP [ Time Frame: Baseline and the last 3 months (months 4, 5, and 6) of the 6-month DBTP ]
The MFIQ is a self-administered 26-item instrument measuring the impact of migraine on broader functioning. Participants responded to 5 items on the impact on physical functioning domain using a 5-point scale assigned scores from 1 to 5, with 5 representing the greatest burden. The scores were calculated as the sum of the item responses rescaled to a 0 to 100 scale, with higher scores representing greater impact of migraine, i.e., higher burden.

The MFIQ physical functioning domain score was calculated per month for months 4, 5, and 6 and the mean over this period was calculated. The MFIQ physical functioning domain score during the 4-week baseline period was then subtracted to calculate the change from baseline in mean MFIQ physical functioning domain score over months 4, 5,and 6 of the 6-month DBTP. A negative change from baseline indicates a better outcome.
Change From Baseline in Mean MFIQ Usual Activities Domain Score Over Months 4, 5, and 6 of the 6-month DBTP [ Time Frame: Baseline and the last 3 months (months 4, 5, and 6) of the 6-month DBTP ]
The MFIQ is a self-administered 26-item instrument measuring the impact of migraine on broader functioning. Participants responded to 10 items on the impact on usual activities domain using a 5-point scale assigned scores from 1 to 5, with 5 representing the greatest burden. The scores were calculated as the sum of the item responses rescaled to a 0 to 100 scale, with higher scores representing greater impact of migraine, i.e., higher burden.

The MFIQ usual activities domain score was calculated per month for months 4, 5, and 6 and the mean over this period was calculated. The MFIQ usual activities domain score during the 4-week baseline period was then subtracted to calculate the change from baseline in mean MFIQ usual activities domain score over months 4, 5,and 6 of the 6-month DBTP. A negative change from baseline indicates a better outcome.
Change From Baseline in Mean MFIQ Social Functioning Domain Score Over Months 4, 5, and 6 of the 6-month DBTP [ Time Frame: Baseline and the last 3 months (months 4, 5, and 6) of the 6-month DBTP ]
The MFIQ is a self-administered 26-item instrument measuring the impact of migraine on broader functioning. Participants responded to 5 items on the impact on social functioning domain using a 5-point scale assigned scores from 1 to 5, with 5 representing the greatest burden. The scores were calculated as the sum of the item responses rescaled to a 0 to 100 scale, with higher scores representing greater impact of migraine, i.e., higher burden.

The MFIQ social functioning domain score was calculated per month for months 4, 5, and 6 and the mean over this period was calculated. The MFIQ social functioning domain score during the 4-week baseline period was then subtracted to calculate the change from baseline in mean MFIQ social functioning domain score over months 4, 5,and 6 of the 6-month DBTP. A negative change from baseline indicates a better outcome.

Eligibility Criteria

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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

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.

Contacts and Locations

Information from the National Library of Medicine

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

Locations

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United States, Alabama
Research Site
Birmingham, Alabama, United States, 35235
Research Site
Huntsville, Alabama, United States, 35805
United States, California
Research Site
Los Angeles, California, United States, 90094
Research Site
Pasadena, California, United States, 91105
United States, Colorado
Research Site
Basalt, Colorado, United States, 81621
United States, Connecticut
Research Site
East Hartford, Connecticut, United States, 06118
Research Site
New London, Connecticut, United States, 06320
Research Site
Stamford, Connecticut, United States, 06905
United States, Florida
Research Site
Jacksonville, Florida, United States, 32216
Research Site
Orlando, Florida, United States, 32806
United States, Louisiana
Research Site
Chalmette, Louisiana, United States, 70043
United States, Maryland
Research Site
Hagerstown, Maryland, United States, 21742
United States, Massachusetts
Research Site
Worcester, Massachusetts, United States, 01605
United States, Michigan
Research Site
Ann Arbor, Michigan, United States, 48104
United States, Minnesota
Research Site
Minneapolis, Minnesota, United States, 55402
United States, Missouri
Research Site
Bolivar, Missouri, United States, 65613
Research Site
Saint Louis, Missouri, United States, 63141
Research Site
Saint Peters, Missouri, United States, 63303
Research Site
Springfield, Missouri, United States, 65810
United States, New Jersey
Research Site
Toms River, New Jersey, United States, 08755
United States, North Carolina
Research Site
Durham, North Carolina, United States, 27713
Research Site
Greensboro, North Carolina, United States, 27405
United States, Ohio
Research Site
Centerville, Ohio, United States, 45459
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Research Site
Nashville, Tennessee, United States, 37203
United States, Texas
Research Site
Austin, Texas, United States, 78731
Research Site
Frisco, Texas, United States, 75034
United States, Utah
Research Site
Salt Lake City, Utah, United States, 84109

Sponsors and Collaborators

Amgen

Novartis

Investigators

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Study Director:	MD	Amgen

Study Documents (Full-Text)

Documents provided by Amgen:

Study Protocol [PDF] August 31, 2020

Statistical Analysis Plan [PDF] October 20, 2020

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

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Responsible Party:	Amgen
ClinicalTrials.gov Identifier:	NCT03912337
Other Study ID Numbers:	20180060
First Posted:	April 11, 2019 Key Record Dates
Results First Posted:	July 20, 2022
Last Update Posted:	July 20, 2022
Last Verified:	July 2022
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

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Amgen:


Episodic migraine Disability Migraine-related disability	Work productivity Erenumab AIMOVIG

Additional relevant MeSH terms:

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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

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