The investigators will evaluate the efficacy for use of intravenous erenumab 140mg for treatment of status migrainosus in an open-label, pilot study.
This will be a single-center, open-label, pilot study. The investigators will enroll 15 subjects. Subjects will be recruited from the outpatient Mayo Headache Clinic. The Headache Clinic employs 5 headache specialists and 1 fellow which is sufficient staffing to support this study and recruitment of patients with status migrainosus. Subject participation would be for a total of 28 days. Subjects will be screened at outpatient clinic visit appointments or when they call into the clinic regarding an episode of status migrainosus and interested qualified subjects will be consented and offered participation in this trial. Once consent has been obtained, subjects will have evaluation of vital signs, pregnancy status, complete blood count, and comprehensive metabolic panel. Abnormal metabolic profile, kidney or liver function will exclude subjects. Pregnancy will exclude subjects. Qualifying subjects will be administered a single dose of intravenous erenumab at our Infusion Center at the first available appointment within 24 hours of qualifying for participation if they continue to have moderate to severe pain and monitored on-site for a minimum of 2 hours after start of drug administration. Subjects will fill out two headache diaries following treatment. The first diary is an hourly diary with entries once every hour for 24 hours, with time point 0 defined as time of when treatment begins. Diary entry at hour 24 coincides with the time point for post-treatment day 1. Follow-up will occur by phone at post-treatment day 1. If pain and symptoms persist, patients will be directed to contact their primary headache provider to receive further management. From this point and onwards, patients will be instructed to fill out a second diary once daily for 28 consecutive calendar days following treatment. A final visit will be conducted at the end of the study at 28 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
140mg single intravenous administration (60 minutes)
Mayo Clinic in Arizona
Phoenix, Arizona, United States
Pain relief at 2 hours
Number of subjects with decreased pain from moderate or severe at baseline to mild or none at 2 hours after treatment
Time frame: 2 hours after treatment
Pain freedom at 2 hours
Number of subjects who become pain free at 2 hours after treatment.
Time frame: 2 hours after treatment
Absence of most bothersome symptom at 2 hours
Number of subjects with absence of most bothersome symptom at 2 hours after treatment.
Time frame: 2 hours after treatment
Relief of most bothersome symptom at 2 hours
Number of subjects with decrease in most bothersome symptom from moderate or severe at baseline to mild or none at 2 hours after treatment.
Time frame: 2 hours after treatment
Pain freedom at 24 hours
Number of subjects who become pain free at 24 hours after treatment
Time frame: 24 hours after treatment
Pain relief at 24 hours
Number of subjects with decrease in pain from moderate or severe at baseline to mild or none at 24 hours after treatment
Time frame: 24 hours after treatment
Sustained pain freedom at 24 hours
Number of subjects who are pain free at 24 hours with no use of rescue medications or relapse within 24 hours of the initial treatment.
Time frame: 24 hours after treatment
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Sustained pain freedom at 48 hours
Number of subjects who are pain free at 48 hours with no use of rescue medications or relapse within 48 hours of the initial treatment.
Time frame: 48 hours after treatment
Sustained pain relief at 24 hours
Number of subjects who have pain relief at 24 hours with no use of rescue medications or relapse within 24 hours of the initial treatment.
Time frame: 24 hours after treatment
Sustained pain relief at 48 hours
Number of subjects who have pain relief at 48 hours with no use of rescue medications or relapse within 48 hours of the initial treatment.
Time frame: 48 hours after treatment
Change in pain intensity at 2 hours
Measured using a self-reported questionnaire to rate headache pain on a numerical rating scale from 0-10, where 0 is no pain and 10 is the worst pain imaginable.
Time frame: Baseline, 2 hours
Change in pain intensity at 24 hours
Measured using a self-reported questionnaire to rate headache pain on a numerical rating scale from 0-10, where 0 is no pain and 10 is the worst pain imaginable.
Time frame: Baseline, 24 hours