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



Status:Completed
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 65
Updated:12/1/2018
Start Date:July 19, 2015
End Date:March 20, 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

To evaluate the effect of erenumab compared to placebo on the change from baseline in monthly
migraine days, in adults with episodic migraine.

Adults with a history of migraine with or without aura for ≥ 12 months and who experience ≥ 4
to < 15 migraine days per month with < 15 headache days per month will be randomized 1:1 to
placebo or erenumab. Double-blind erenumab or placebo will be administered during the 12-week
double-blind treatment phase and open-label erenumab will be administered during the 28-week
open-label treatment phase.

Inclusion Criteria:

- History of migraines (with or without aura) for ≥ 12 months

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

- Headache (ie, migraine and non-migraine headache) frequency: < 15 headache days per
month on average across the 3 months prior to screening

- Demonstrated 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 headaches

- No therapeutic response with > 2 categories for prophylactic treatment of migraine
after an adequate therapeutic trial.

- 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

- Used a prohibited medication, device, or procedure within 2 months prior to the start
of the baseline phase or during the baseline phase.

- Received botulinum toxin

- Anticipated to require any excluded medication, device, or procedure during the study.

- Active chronic pain syndromes (such as fibromyalgia and chronic pelvic pain).

- History of major psychiatric disorder.

- History of seizure disorder or other significant neurological conditions other than
migraine.

- Human immunodeficiency virus (HIV) infection by history.

- Myocardial infarction (MI), stroke, transient ischemic attack (TIA), unstable angina,
or coronary artery bypass surgery or other revascularization procedure within 12
months prior to screening.

- The subject is at risk of self-harm or harm to others. Previously randomized into an
AMG 334 study.

- Unlikely to be able to complete all protocol required study visits or procedures,
and/or to comply with all required study procedures.
We found this trial at
41
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