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Study Complete
Sponsor ID
20120178

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

Sponsor ID
20120178
Clinicaltrials.gov ID
NCT01952574
EUCTIS ID
N/A
EudraCT ID
2012-005331-90
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Study Details

A study to evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days in participants with episodic migraine.

Additional Study Details

Phase
Phase 2
Product
AMG 334
Type
Interventional
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Enrollment
483
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 in the last 4 weeks of the 12-week double-blind treatment phase

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

Change in monthly migraine attacks 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

Adverse events, clinical laboratory values, electrocardiogram, vital signs, anti-AMG 334 antibodies

Timeframe: Completion of double-blind treatment phase at 12 weeks and open-label treatment phase and safety follow-up at end of study

Study Documents

Study Synopsis
Available Language(s): English
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Locations

Location
Status
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Location
Research Site
Arlington, TX, United States, 76017
Status
Completed
Location
Research Site
Raleigh, NC, United States, 27612
Status
Completed
Location
Research Site
Ann Arbor, MI, United States, 48104
Status
Recruiting
Location
Research Site
Austin, TX, United States, 78731
Status
Recruiting
Location
Research Site
Berlin, Germany, 10435
Status
Recruiting
Location
Research Site
Bradenton, FL, United States, 34205
Status
Recruiting
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Study Info
Age
18 - 60 Years
Condition
  • Migraine
    • Sex
    All
    Trial Dates
    Aug 2013 - Sep 2014
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - History of migraine for more than12 months prior to screening - Migraine frequency: ≥ 4 and ≤ 14 migraine days per month in each of the 3 months prior to screening and during baseline phase - Headache frequency: < 15 headache days per month (with > 50% of the headache days being migraine days) in each of the 3 months prior to screening and during baseline phase - Demonstrated at least 80% compliance with the eDiary during baseline phase
    Exclusion Criteria:
    - Older than 50 years of age at migraine onset - History of cluster headache or basilar or hemiplegic migraine headache - Unable to differentiate migraine from other headaches - No therapeutic response with > 2 of the following eight medication categories for prophylactic treatment of migraine after an adequate therapeutic trial. Medication categories are: -- Category 1: Divalproex sodium, sodium valproate -- Category 2: Topiramate -- Category 3: Beta blockers (for example: atenolol, bisoprolol, metoprolol, nadolol, nebivolol, pindolol, propranolol, timolol) -- Category 4: Tricyclic antidepressants (for example: amitriptyline, nortriptyline, protriptyline) -- Category 5: Venlafaxine, desvenlafaxine, duloxetine, milnacipran -- Category 6: Flunarizine, verapamil -- Category 7: Lisinopril, candesartan -- Category 8: Butterbur, feverfew, magnesium (≥ 600 mg/day), riboflavin (≥ 100 mg/day) - Overuse of acute migraine medications in any month during the 3 months prior to screening or during screening