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Study Complete
Sponsor ID
20120296

Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine PreventionSTRIVE

Sponsor ID
20120296
Clinicaltrials.gov ID
NCT02456740
EUCTIS ID
N/A
EudraCT ID
2014-004464-38
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Study Details

The primary objective of the study was to evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days.

Additional Study Details

Phase
Phase 3
Product
AMG 334
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
955
Additional Study Details

Protocol Summary

Primary Outcome Measures

Change from baseline in mean monthly migraine days

Timeframe: Completion of double blind treatment phase at 24 weeks.

Secondary Outcome Measures

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

Timeframe: Completion of double blind treatment phase at 24 weeks

Change from baseline in mean monthly acute migraine-specific medication treatment days.

Timeframe: Completion of double blind treatment phase at 24 weeks

Change from baseline in physical impairment.

Timeframe: Completion of double blind treatment phase at 24 weeks

Change from baseline on impact on everyday activities.

Timeframe: Completion of double blind treatment phase at 24 weeks

Study Documents

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

Locations

Location
Status
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Location
Research Site
Boise, ID, United States, 83704
Status
Recruiting
Location
Research Site
Boulder, CO, United States, 80301
Status
Recruiting
Location
Research Site
Cleveland, OH, United States, 44122
Status
Recruiting
Location
Research Site
Edgewood, KY, United States, 41017
Status
Recruiting
Location
Research Site
Nashville, TN, United States, 37203
Status
Recruiting
Location
Research Site
Phoenix, AZ, United States, 85023
Status
Recruiting
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Study Info
Age
18 - 65 Years
Condition
  • Migraine
    • Sex
    All
    Trial Dates
    Jul 2015 - Sep 2016
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - History of migraine (with or without aura) for ≥ 12 months prior to screening according to the International Headache Society (IHS) International Classification of Headache Disorders (ICHD-3) classification - Migraine frequency: ≥ 4 and < 15 migraine days per month on average across the 3 months prior to screening and during baseline - Headache frequency: < 15 headache days per month on average across the 3 months prior to screening and baseline - Demonstrated at least 80% compliance with the eDiary.
    Exclusion Criteria:
    - Older than 50 years of age at migraine onset - History of cluster headache or hemiplegic migraine headache - Unable to differentiate migraine from other headache - No therapeutic response with > 2 medication categories for prophylactic treatment of migraine after an adequate therapeutic trial - Used a prohibited medication, device, or procedure within 2 months prior to the start of the baseline phase or during the baseline phase - Concomitant use of 2 or more medications with possible migraine prophylactic effects within 2 months prior to the start of the baseline phase or during the baseline phase. If only 1 prophylactic medication is used, the dose must be stable within 2 months prior to the start of the baseline phase and throughout the study