Study to Evaluate the Efficacy and Safety of AMG 301 in Migraine Prevention

• Status: Completed
• Trial end date: 2019-02-04
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the effect of AMG 301 compared to placebo on the change from the baseline period in monthly migraine days in subjects with migraine.

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

Details

• Lead Sponsor: Amgen

Criteria

Inclusion Criteria:

• Adults ≥ 18 to ≤ 60 years of age at the time of signing the informed consent form.

• History of migraine (with or without aura) for ≥ 12 months before screening according to the International Headache Society (IHS) Classification ICHD-III (Headache Classification Committee of the International Headache Society, 2013)

• Migraine frequency: ≥ 4 migraine days per month on average across the 3 months before screening.

• Failed at least 1 medication for prophylactic treatment of migraine due to tolerability or lack of efficacy

Exclusion Criteria:

• Older than 50 years of age at migraine onset.

• History of cluster headache, hemiplegic migraine headache.

• Unable to differentiate migraine from other headaches.

• Migraine with continuous pain, in which the subject does not experience any pain-free periods (of any duration) during the 1 month before the screening period.

• History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.