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

• Status: Completed
• Trial end date: 2017-06-19
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study was to evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days.

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

Details

• Lead Sponsor: Amgen
• Treatments: Erenumab

Criteria

Inclusion Criteria:

• History of migraine (with or without aura) for ≥ 12 months prior to screening according to the International Headache Society (IHS) International Classification of Headache Disorders (ICHD-3) classification

• Migraine frequency: ≥ 4 and < 15 migraine days per month on average across the 3 months prior to screening and during baseline

• Headache frequency: < 15 headache days per month on average across the 3 months prior to screening and baseline

• Demonstrated at least 80% 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 headache

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

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

• 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