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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 : Not yet recruiting
First Posted : April 11, 2019
Last Update Posted : August 5, 2019
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Amgen

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.

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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.
Estimated Study Start Date : October 21, 2019
Estimated Primary Completion Date : March 10, 2021
Estimated Study Completion Date : March 10, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

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




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.



Information from the National Library of Medicine

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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 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 in the past month prior to initial screening
  • 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 12 days during the 3 months prior to screening for any indication
  • Taken a butalbital and/or butalbital-containing analgesic greater than 6 days during the 3 months 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 either acute or preventive settings

Other inclusion and exclusion criteria may apply.


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


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

Sponsors and Collaborators
Amgen
Novartis
Investigators
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Study Director: MD Amgen

Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT03912337     History of Changes
Other Study ID Numbers: 20180060
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: July 2019
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 link 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
Antibodies, Monoclonal
Calcitonin Gene-Related Peptide Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Immunologic Factors