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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 (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
Last Update Posted : November 19, 2021
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE April 10, 2019
First Posted Date  ICMJE April 11, 2019
Last Update Posted Date November 19, 2021
Actual Study Start Date  ICMJE December 4, 2019
Actual Primary Completion Date July 26, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2019)
  • 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 measured by Migraine Functional Impact Questionnaire (MFIQ) [ 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 measured by Migraine Functional Impact Questionnaire (MFIQ) [ 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 measured by Migraine Functional Impact Questionnaire (MFIQ) [ 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Erenumab-aooe on Disability and Work Productivity in Employed Subjects With Episodic Migraine
Official Title  ICMJE 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.
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Migraine
Intervention  ICMJE
  • Drug: Placebo
    Placebo once every 4 weeks. SC injection.
  • Drug: Erenumab
    Erenumab once every 4 weeks. SC injection.
    Other Name: Aimovig
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Placebo
  • 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.
    Intervention: Drug: Erenumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 28, 2021)
29
Original Estimated Enrollment  ICMJE
 (submitted: April 10, 2019)
240
Actual Study Completion Date  ICMJE July 26, 2021
Actual Primary Completion Date July 26, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03912337
Other Study ID Numbers  ICMJE 20180060
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: 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
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Novartis
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP