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

NCT03912337 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 20180060
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 28

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.

Conditions

Migraine

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Sum of Monthly Changes From Baseline in Modified MIDAS Total Score Over the 6-month DBTP

  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.

  Baseline and Months 1 to 6

Secondary Outcomes (5)

• Change From Baseline in Mean MMD Over Months 4, 5, and 6 of the 6-month DBTP

  Baseline and the last 3 months (months 4, 5, and 6) of the 6-month DBTP

• Change From Baseline in Mean Monthly Percent Work Impairment Over Months 4, 5, and 6 of the 6-month DBTP

  Baseline and the last 3 months (months 4, 5, and 6) of the 6-month DBTP

• Change From Baseline in Mean MFIQ Physical Functioning Domain Score Over Months 4, 5, and 6 of the 6-month DBTP

  Baseline and the last 3 months (months 4, 5, and 6) of the 6-month DBTP

• Change From Baseline in Mean MFIQ Usual Activities Domain Score Over Months 4, 5, and 6 of the 6-month DBTP

  Baseline and the last 3 months (months 4, 5, and 6) of the 6-month DBTP

• Change From Baseline in Mean MFIQ Social Functioning Domain Score Over Months 4, 5, and 6 of the 6-month DBTP

  Baseline and the last 3 months (months 4, 5, and 6) of the 6-month DBTP

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Erenumab

EXPERIMENTAL

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

Interventions

Placebo DRUG

Placebo once every 4 weeks. SC injection.

Placebo

Erenumab DRUG

Erenumab once every 4 weeks. SC injection.

Also known as: Aimovig

Erenumab

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead
• Novartis: collaborator

Study Sites (28)

Research Site

Birmingham, Alabama, 35235, United States

Location

Research Site

Huntsville, Alabama, 35805, United States

Location

Research Site

Los Angeles, California, 90094, United States

Location

Research Site

Pasadena, California, 91105, United States

Location

Research Site

Basalt, Colorado, 81621, United States

Location

Research Site

East Hartford, Connecticut, 06118, United States

Location

Research Site

New London, Connecticut, 06320, United States

Location

Research Site

Stamford, Connecticut, 06905, United States

Location

Research Site

Jacksonville, Florida, 32216, United States

Location

Research Site

Orlando, Florida, 32806, United States

Location

Research Site

Chalmette, Louisiana, 70043, United States

Location

Research Site

Hagerstown, Maryland, 21742, United States

Location

Research Site

Worcester, Massachusetts, 01605, United States

Location

Research Site

Ann Arbor, Michigan, 48104, United States

Location

Research Site

Minneapolis, Minnesota, 55402, United States

Location

Research Site

Bolivar, Missouri, 65613, United States

Location

Research Site

City of Saint Peters, Missouri, 63303, United States

Location

Research Site

Springfield, Missouri, 65810, United States

Location

Research Site

St Louis, Missouri, 63141, United States

Location

Research Site

Toms River, New Jersey, 08755, United States

Location

Research Site

Durham, North Carolina, 27713, United States

Location

Research Site

Greensboro, North Carolina, 27405, United States

Location

Research Site

Centerville, Ohio, 45459, United States

Location

Research Site

Philadelphia, Pennsylvania, 19107, United States

Location

Research Site

Nashville, Tennessee, 37203, United States

Location

Research Site

Austin, Texas, 78731, United States

Location

Research Site

Frisco, Texas, 75034, United States

Location

Research Site

Salt Lake City, Utah, 84109, United States

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Migraine Disorders

Interventions

erenumab

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Limitations and Caveats

The study was terminated early due to slow enrollment and the impact of COVID-19 on the work productivity study endpoints, beyond normal operational disruptions.

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 11, 2019
• Study Start: December 4, 2019
• Primary Completion: July 28, 2021
• Study Completion: July 28, 2021
• Last Updated: July 20, 2022
• Results First Posted: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

US (28)