Overview
Study to Evaluate the Efficacy and Safety of AMG 301 in Migraine Prevention
Status:
Completed
Completed
Trial end date:
2019-02-04
2019-02-04
Target enrollment:
0
0
Participant gender:
All
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 2Accepts Healthy Volunteers?
NoDetails
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.