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

• ClinicalTrials.gov Identifier: NCT03912337
• Recruitment Status: Recruiting
• First Posted: April 11, 2019
• Last Update Posted: December 31, 2020
• Sponsor: Amgen
• 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

• 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

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 :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.

Eligibility Criteria

• 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

Contacts

Contact: Amgen Call Center; 866-572-6436; medinfo@amgen.com

Locations

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

Sponsors and Collaborators

Amgen

Novartis

Investigators

• Study Director: MD; Amgen

More Information

Additional Information:

AmgenTrials clinical trials website 

• Responsible Party: Amgen
• ClinicalTrials.gov Identifier: NCT03912337
• Other Study ID Numbers: 20180060
• First Posted: April 11, 2019
• 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

Keywords provided by Amgen:

Episodic migraine; Disability; Migraine-related disability; Work productivity; Erenumab; AIMOVIG

Additional relevant MeSH terms:

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