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Terminated/Withdrawn
Sponsor ID
20180060

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

Sponsor ID
20180060
Clinicaltrials.gov ID
NCT03912337
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 4
Product
AMG 334
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
29
Additional Study Details

Protocol Summary

Primary Outcome Measures

Sum of monthly changes from baseline in modified Migraine Disability Assessment (MIDAS)

Timeframe: Entire 6-month double-blind period

Secondary Outcome Measures

Change from baseline in mean monthly migraine days (MMD)

Timeframe: Months 4, 5, and 6

Change from baseline in mean monthly percent work impairment

Timeframe: Months 4, 5 and 6

Change from baseline in mean physical function

Timeframe: Months 4, 5, and 6

Change from baseline in mean usual activities

Timeframe: Months 4, 5 and 6

Change from baseline in mean social function

Timeframe: Months 4, 5, and 6

Locations

Location
Status
Contact Us
Location
Research Site
Nashville, TN, United States, 37203
Status
Completed
Location
Research Site
Orlando, FL, United States, 32806
Status
Recruiting
Location
Research Site
Worcester, MA, United States, 01605
Status
Recruiting
Location
Research Site
Basalt, CO, United States, 81621
Status
Recruiting
Location
Research Site
Huntsville, AL, United States, 35805
Status
Recruiting
Location
Research Site
Minneapolis, MN, United States, 55402
Status
Completed
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Study Info
Age
18 - 99 Years
Condition
  • Migraine
    • Sex
    All
    Trial Dates
    Dec 2019 - Jul 2021
    Inclusion and Exclusion 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.