Effect of Erenumab-aooe on Disability and Work Productivity in Employed Subjects With Episodic Mi… (NCT03912337) | Clinical Trial Compass
TerminatedPhase 4
Effect of Erenumab-aooe on Disability and Work Productivity in Employed Subjects With Episodic Migraine
Stopped: Terminated \[Study would not complete enrollment target until 2026 with results available in 2027. The information will not be useful at that time.\]
United States29 participantsStarted 2019-12-04
Plain-language 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.
Who can participate
Age range18 Years – 99 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 mo…
What they're measuring
1
Sum of Monthly Changes From Baseline in Modified MIDAS Total Score Over the 6-month DBTP