Status:
COMPLETED
Study to Evaluate the Efficacy and Safety of AMG 301 in Migraine Prevention
Lead Sponsor:
Amgen
Conditions:
Chronic Migraine or Episodic Migraine
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief 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.
Detailed Description
A Phase 2a, randomized, double-blind, placebo-controlled, 3-arm parallel group study to evaluate the efficacy and safety of AMG 301 in subjects with chronic migraine or episodic migraine.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 4 2019
Estimated Enrollment :
343 Patients enrolled
Trial Details
Trial ID
NCT03238781
Start Date
September 6 2017
End Date
February 4 2019
Last Update
February 7 2020
Active Locations (49)
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1
Research Site
Long Beach, California, United States, 90806
2
Research Site
Santa Monica, California, United States, 90404
3
Research Site
Boulder, Colorado, United States, 80301
4
Research Site
East Hartford, Connecticut, United States, 06118