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

Completed · Phase 3 · Has a placebo group

Conditions studied: Migraine

In brief

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.

Key facts

Study ID

NCT02456740

Run by

Amgen

People needed

955

Starts

2015-07-17

Expected to finish

2017-06-19

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 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.

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 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

Where it is running

• Research Site — Anaheim, California, United States
• Research Site — Encino, California, United States
• Research Site — Irvine, California, United States
• Research Site — Los Alamitos, California, United States
• Research Site — Newport Beach, California, United States
• Research Site — Rancho Mirage, California, United States
• Research Site — Redlands, California, United States
• Research Site — Sherman Oaks, California, United States
• Research Site — Simi Valley, California, United States
• Research Site — Spring Valley, California, United States
• Research Site — Boulder, Colorado, United States
• Research Site — East Hartford, Connecticut, United States
• Research Site — Stamford, Connecticut, United States
• Research Site — Waterbury, Connecticut, United States
• Research Site — Bradenton, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Leesburg, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Ocala, Florida, United States
• Research Site — Orlando, Florida, United States
• Research Site — Sunrise, Florida, United States
• Research Site — West Palm Beach, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Boise, Idaho, United States
• Research Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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