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



Status:Completed
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 65
Updated:12/1/2018
Start Date:July 17, 2015
End Date:June 19, 2017

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A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention

The primary objective of the study was to evaluate the effect of erenumab compared to placebo
on the change from baseline in monthly migraine days.

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
We found this trial at
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