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

• Status: Completed
• Trial end date: 2016-04-28
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Erenumab

Criteria

Inclusion Criteria:

• History of at least 5 attacks of migraine without aura and/or migraine with visual sensory, speech and/or language, retinal or brainstem aura.

• History of ≥ 15 headache days per month of which ≥ 8 headache days were assessed by the subject as migraine day.

• ≥ 4 distinct headache episodes, each lasting ≥ 4 hours OR if shorter, associated with use of a triptan or ergot-derivative on the same calendar day based on the eDiary calculations.

• Demonstrated at least 80% compliance with the eDiary.

Exclusion Criteria:

• History of cluster headache or hemiplegic migraine headache

• Unable to differentiate migraine from other headaches

• Failed > 3 medication categories due to lack of efficacy for prophylactic treatment of migraine .

• Received botulinum toxinin head or neck region within 4 months prior to screening.

• Used a prohibited migraine prophylactic medication, device or procedure within 2 months prior to the start of the baseline phase