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

• Status: Completed
• Trial end date: 2017-03-20
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Erenumab

Criteria

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.