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 range
18 Years – 99 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sum of Monthly Changes From Baseline in Modified MIDAS Total Score Over the 6-month DBTP