Table 1.

Erenumab in episodic migraine: Phase II and Phase III studies

Protocol and date of completion	Population active vs placebo	Modality of administration	Primary efficacy outcome	Adverse events (AEs)
NCT01952574 Phase II, randomized double-blind placebo-controlled, June 2014	483 (108, 108, 107 vs 160)	7, 21, 70 mg sc once/month for 12 weeks	Week 9–12 vs basis decrease in migraine days; 70 mg vs placebo (P<0.03)	Fatigue, nasopharyngitis, headache, vertigo
NCT02483585 – ARISE Phase III, randomized double-blind placebo-controlled, March 2017	577	70 mg sc for 12 weeks	Weeks 9–12 vs basis decrease in migraine days and migraine medications; 70 mg vs placebo (0.001<P<0.003)	Upper respiratory tract infection, injection site pain, nausea, nasopharyngitis
NCT02456740 – STRIVE Phase III, randomized double-blind placebo-controlled, June 2017	955	70, 140 mg sc once/month for 24 weeks	24 weeks vs basis: decrease in number of monthly migraine days, migraine medications, MPFID-EA, and MPFID-PI; 70 mg and 140mg vs placebo (P<0.001)	Upper respiratory tract infection, injection site pain, nausea, nasopharyngitis
NCT03096834 CAMG334A2301, Phase IIIb, randomized double-blind, March 2019, followed by a 1 year open label phase	382	Single dose sc once/month for 12 weeks	Reduction in migraine days and improvement in patients’ quality of life	N/A

Abbreviations: MPFID-EA, impact of migraine on everyday activities as evaluated via the Migraine Physical Function Impact Diary; MPFID-PI, mean physical impairment domain score as measured by the Migraine Physical Function Impact Diary; N/A, not applicable sc, subcutaneous.