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

Completed · Phase 3 · Has a placebo group

Conditions studied: Migraine

In brief

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

Key facts

Study ID: NCT02483585
Run by: Amgen
People needed: 577
Starts: 2015-07-20
Expected to finish: 2017-03-20
Last updated by the study team: 2022-10-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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.

Where it is running

Research Site — Phoenix, Arizona, United States
Research Site — Culver City, California, United States
Research Site — Long Beach, California, United States
Research Site — Sacramento, California, United States
Research Site — San Diego, California, United States
Research Site — Santa Monica, California, United States
Research Site — Walnut Creek, California, United States
Research Site — Colorado Springs, Colorado, United States
Research Site — Fairfield, Connecticut, United States
Research Site — Hollywood, Florida, United States
Research Site — Jacksonville, Florida, United States
Research Site — Orlando, Florida, United States
Research Site — Oviedo, Florida, United States
Research Site — Palm Beach Gardens, Florida, United States
Research Site — Atlanta, Georgia, United States
Research Site — Gurnee, Illinois, United States
Research Site — Indianapolis, Indiana, United States
Research Site — Lenexa, Kansas, United States
Research Site — Lexington, Kentucky, United States
Research Site — Baltimore, Maryland, United States
Research Site — Boston, Massachusetts, United States
Research Site — Ann Arbor, Michigan, United States
Research Site — Kalamazoo, Michigan, United States
Research Site — Princeton, New Jersey, United States
Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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