Effect of Erenumab-aooe on Disability and Work Productivity in Employed Subjects With Episodic Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Placebo; Erenumab
Intervention description: Placebo once every 4 weeks. SC injection.; Erenumab once every 4 weeks. SC injection.
Intervention MeSH terms: Erenumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Episodic migraine; Disability; Migraine-related disability; Work productivity; Erenumab; AIMOVIG

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.
    

Eligibility 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.