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Study Complete
Sponsor ID
20150308

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

Sponsor ID
20150308
Clinicaltrials.gov ID
NCT03238781
EUCTIS ID
N/A
EudraCT ID
2017-000630-57
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Study Details

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.

Additional Study Details

Phase
Phase 2
Product
AMG 301
Type
Interventional
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Enrollment
343
Additional Study Details

Protocol Summary

Primary Outcome Measures

Change from the baseline period in monthly migraine days. The monthly migraine days will be calculated using the migraine days over the last 4 weeks of the 12-week double-blind treatment period.

Timeframe: Last 4 weeks

Secondary Outcome Measures

At least a 50% reduction from the baseline period in monthly migraine days in the last 4 weeks of the 12-week double-blind treatment period

Timeframe: Last 4 weeks

Change from the baseline period in monthly acute migraine-specific medication days in the last 4 weeks of the 12-week double-blind treatment period.

Timeframe: Last 4 weeks

Change from the baseline period in mean physical impairment domain scores as measured by the MPFID over the last 4 weeks of the 12-week double-blind treatment period.

Timeframe: Last 4 weeks

Change from the baseline period in mean impact on everyday activities domain scores as measured by the MPFID over the last 4 weeks of the 12-week double-blind treatment period.

Timeframe: Last 4 weeks

Locations

Location
Status
Contact Us
Location
Research Site
Ann Arbor, MI, United States, 48104
Status
Recruiting
Location
Research Site
Austin, TX, United States, 78731
Status
Recruiting
Location
Research Site
Boulder, CO, United States, 80301
Status
Recruiting
Location
Research Site
Dallas, TX, United States, 75214
Status
Recruiting
Location
Research Site
Saint Peters, MO, United States, 63303
Status
Recruiting
Location
Research Site
Salt Lake City, UT, United States, 84109
Status
Recruiting
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Study Info
Age
18 - 60 Years
Condition
  • Migraine
    • Sex
    All
    Trial Dates
    Sep 2017 - Oct 2018
    Inclusion and Exclusion 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.