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

CompletedPhase 2NCT03238781
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

Brief summary (from the registry)

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.

Study details

Official title
A Phase 2a Randomized Double-blind Placebo Controlled Study to Evaluate the Efficacy and Safety of AMG 301 in Migraine Prevention
Conditions
  • Chronic Migraine or Episodic Migraine
Interventions
Sponsor
Amgen
Start date
2017-09-06
Primary completion
2018-10-16
Sex
All
Age range
from 18 Years to 60 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
Austria, Canada, Czechia, Denmark, Finland, Germany, Sweden, United States
Total sites listed
49

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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.

Canadian sites (6)

FacilityCityProvince
Research SiteCalgaryAlberta
Research SiteSurreyBritish Columbia
Research SiteMarkhamOntario
Research SiteTorontoOntario
Research SiteLévisQuebec
Research SiteMontrealQuebec
Canadian sites for NCT03238781CalgarySurreyMarkhamTorontoLévisMontreal
Canadian sites for NCT03238781. 6 mapped locations with coordinates in the registry. Schematic plot, not to scale.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03238781