A Phase 2 Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention
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|ClinicalTrials.gov Identifier: NCT01952574|
Recruitment Status : Active, not recruiting
First Posted : September 30, 2013
Results First Posted : July 10, 2018
Last Update Posted : July 16, 2019
|Study Design||Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Prevention|
This study was conducted at 59 centers in North America (Canada, USA) and Europe (Denmark, Finland, Germany, Norway, Sweden, and Portugal).
Results are reported for the 12-week double-blind treatment phase (data cutoff date 04 November 2014). Three hundred and forty-four participants are ongoing in the open-label extension phase of the study.
|Pre-assignment Details||Participants were randomized 3:2:2:2 to receive placebo, erenumab 7 mg, erenumab 21 mg, or erenumab 70 mg once a month (QM), respectively. Randomization was stratified by region (North America vs. other).|