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Keep this study
Lead
Amgen
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.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) Compared to Placebo in Migraine Prevention
