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Study Complete
Sponsor ID
20120295

A Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Chronic Migraine Prevention

Sponsor ID
20120295
Clinicaltrials.gov ID
NCT02066415
EUCTIS ID
N/A
EudraCT ID
2013-001707-36
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Study Details

To evaluate the effect of erenumab compared to placebo on the change from baseline in the number of monthly migraine days in adults with chronic migraine.

Additional Study Details

Phase
Phase 2
Product
AMG 334
Type
Interventional
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Enrollment
667
Additional Study Details

Protocol Summary

Primary Outcome Measures

Change in monthly migraine days from baseline in the last 4 weeks of the 12-week double-blind treatment phase.

Timeframe: Completion of double-blind treatment phase at 12 weeks

Secondary Outcome Measures

Proportion of subjects with at least a 50% reduction from baseline in monthly migraine days

Timeframe: Completion of double-blind treatment phase at 12 weeks

Change in monthly acute migraine-specific medication treatment days

Timeframe: Completion of double-blind treatment phase at 12 weeks

Change in monthly cumulative hours of headache

Timeframe: Completion of double-blind treatment phase at 12 weeks

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
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Location
Research Site
Ann Arbor, MI, United States, 48104
Status
Recruiting
Location
Research Site
Atlanta, GA, United States, 30342
Status
Recruiting
Location
Research Site
Decatur, GA, United States, 30033
Status
Recruiting
Location
Research Site
Greensboro, NC, United States, 27405
Status
Recruiting
Location
Research Site
Indianapolis, IN, United States, 46256
Status
Recruiting
Location
Research Site
Nashville, TN, United States, 37203
Status
Recruiting
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Study Info
Age
18 - 65 Years
Condition
  • Migraine
    • Sex
    All
    Trial Dates
    Mar 2014 - Feb 2016
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - History of at least 5 attacks of migraine without aura and/or migraine with visual sensory, speech and/or language, retinal or brainstem aura. - History of ≥ 15 headache days per month of which ≥ 8 headache days were assessed by the subject as migraine day. - ≥ 4 distinct headache episodes, each lasting ≥ 4 hours OR if shorter, associated with use of a triptan or ergot-derivative on the same calendar day based on the eDiary calculations. - Demonstrated at least 80% compliance with the eDiary.
    Exclusion Criteria:
    - History of cluster headache or hemiplegic migraine headache - Unable to differentiate migraine from other headaches - Failed > 3 medication categories due to lack of efficacy for prophylactic treatment of migraine . - Received botulinum toxinin head or neck region within 4 months prior to screening. - Used a prohibited migraine prophylactic medication, device or procedure within 2 months prior to the start of the baseline phase