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

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Migraine or Episodic Migraine

In brief

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.

Key facts

Study ID

NCT03238781

Run by

Amgen

People needed

343

Starts

2017-09-06

Expected to finish

2019-02-04

Last updated by the study team

2020-02-07

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Research Site — Long Beach, California, United States
• Research Site — Santa Monica, California, United States
• Research Site — Boulder, Colorado, United States
• Research Site — East Hartford, Connecticut, United States
• Research Site — Stamford, Connecticut, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Orlando, Florida, United States
• Research Site — West Palm Beach, Florida, United States
• Research Site — Worcester, Massachusetts, United States
• Research Site — Ann Arbor, Michigan, United States
• Research Site — City of Saint Peters, Missouri, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Plainview, New York, United States
• Research Site — Greensboro, North Carolina, United States
• Research Site — Cleveland, Ohio, United States
• Research Site — Memphis, Tennessee, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — Austin, Texas, United States
• Research Site — Dallas, Texas, United States
• Research Site — Round Rock, Texas, United States
• Research Site — Salt Lake City, Utah, United States
• Research Site — Innsbruck, Austria
• Research Site — Klagenfurt, Austria
• Research Site — Vienna, Austria
• Research Site — Calgary, Alberta, Canada

Full record on ClinicalTrials.gov

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