Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention

This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial.
The trial consisted of four phases: screening (≤ 3 weeks of initial screening and a 4-week
baseline phase); the double-blind treatment phase (24 weeks) in which participants received
placebo or erenumab 70 mg or 140 mg daily; the active-treatment phase, in which participants
underwent repeat randomization and were assigned to receive 70 mg or 140 mg of erenumab (28
weeks); and a safety follow-up phase (12 weeks).

Inclusion Criteria:

- History of migraine (with or without aura) for ≥ 12 months prior to screening
according to the International Headache Society (IHS) International Classification of
Headache Disorders (ICHD-3) classification

- Migraine frequency: ≥ 4 and < 15 migraine days per month on average across the 3
months prior to screening and during baseline

- Headache frequency: < 15 headache days per month on average across the 3 months prior
to screening and baseline

- Demonstrated at least 80% compliance with the eDiary.

Exclusion Criteria:

- Older than 50 years of age at migraine onset

- History of cluster headache or hemiplegic migraine headache

- Unable to differentiate migraine from other headache

- 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 months 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 months 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