pISSN 1226-6051
eISSN 2508-786X

Table. 1.

Table. 1.

Summary of study designs for the three clinical trials of erenumab for the prevention of migraine

STUDY 1 (STRIVE) (NCT02456740; Goadsby 2017)STUDY 2 (ARISE) (NCT02483585; Dodick 2018)STUDY 3 (Tepper et al.) (NCT02066415; Tepper 2017)
Subjects (n)955577667
Sites121 in US, Canada, Belgium, Czech Republic, Finland, Germany, Netherlands, Poland, Slovakia, Sweden, UK, Turkey69 in Denmark, France, Greece, Portugal, Russian Federation, Spain, Switzerland, US69 in Canada, US, Czech Republic, Denmark, Finland, Germany, Norway, Poland, Sweden, UK
Designmc, r, db, pc, pg, phase 3 trialmc, r, db, pc, pg, phase 2 trial
Inclusion criteria• history of migraine (with or without aura) for ≥12 mo prior to screening according to the ICHD-3/HIS • migraine frequency: ≥4 and <15 migraine days per month on average across the 3 mo prior to screening and during baseline phase • headache frequency: <15 headache days per month on average across the 3 mo prior to screening and during baseline phase • patients who demonstrated at least 80% compliance with the eDiary• history of at least 5 attacks of migraine with or without aura • ≥4 distinct headache episodes, each lasting ≥4 h OR if shorter, associated with use of a triptan or ergot-derivative • patients who demonstrated at least 80% compliance with the eDiary
Exclusion criteria• older than 50 yo at migraine onset • history of cluster headache or hemiplegic migraine headache • unable to differentiate migraine from other headaches • no therapeutic response with >2 medication categories for prophylactic treatment of migraine after an adequate therapeutic trial • used a prohibited medication, device, or procedure within 2 mo prior to the start of the baseline phase or during the baseline phase • concomitant use of 2 or more medications with possible migraine prophylactic effects within 2 mo prior to the start of the baseline phase or during the baseline phase. If only 1 prophylactic medication is used, the dose must be stable within 2 months prior to the start of the baseline phase and throughout the study• older than 50 yo at migraine onset • history of cluster headache or hemiplegic migraine headache • unable to differentiate migraine from other headaches • failed >3 medication categories due to lack of efficacy for prophylactic treatment of migraine • used a prohibited migraine prophylactic medication, device or procedure within 2 months prior to the start of the baseline phase • received botulinum toxin in head or neck region within 4 mo prior to screening
Duration6 months12 weeks12 weeks
Treatment regimenpbo (n = 319)Erenumab 70 mg qM SC × 6 mo (n = 317)Erenumab 140 mg qM SC × 6 mo (n = 319)pbo (n = 291)Erenumab 70 mg qM SC × 3 mo (n = 286)pbo (n = 286)Erenumab 70 mg qM SC × 3 mo (n = 191)Erenumab 140 mg qM SC × 3 mo (n = 190)
Primary endpointschange from baseline in mean monthly migraine days for the last 3 monthschange from baseline in monthly migraine days
Secondary endpoints• percentage of participants with at least a 50% reduction from baseline in monthly migraine days in the last 3 months of the double-blind treatment phase • change from baseline in monthly acute migraine-specific medication treatment days to the last 3 months of the double-blind treatment period • change from baseline in mean monthly average physical impairment domain score measured by mpfid in the last 3 months of the double-blind treatment phase • change from baseline in mean monthly average impact on everyday activities score measured by mpfid in the last 3 months of the double-blind treatment phase• percentage of participants with at least a 50% reduction from baseline in monthly migraine days at week 12 • change from baseline in monthly acute migraine-specific medication treatment days at week 12 • percentage of participants with at least a 5-point reduction from baseline in average impact on everyday activities domain score measured by mpfid at week 12 • percentage of participants with at least a 5-point reduction from baseline in average impact on physical impairment domain score measured by mpfid at week 12• percentage of participants with at least a 50% reduction in monthly migraine days from baseline • change from baseline in monthly acute migraine-specific medication treatment days • change from baseline in cumulative monthly headache hours

db: double-blind, ICHD-3/IHS: International Classification of Headache Disorders classification by International Headache Society, mc: multi-center, mpfid: migraine physical function impact diary; pbo: placebo, pc: placebo-controlled, qM; monthly, r: randomized, SC: subcutaneous injection

Korean J Clin Pharm 2019;29:71-8 https://doi.org/10.24304/kjcp.2019.29.2.71
© 2019 Korean J Clin Pharm