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

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

Brief Summary:
A phase 2 study to evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days in participants with episodic migraine.

Detailed Description:
The study is composed of an initial screening phase (up to 3 weeks), a 4-week baseline phase, a 12-week double-blind treatment phase, an open-label treatment phase for up to 256 weeks, and an 8-week safety follow-up (12 weeks after the last dose of investigational product). After implementation of Protocol Amendment 3, participants will increase open-label erenumab to 140 mg monthly and will have a 12-week safety follow-up (16 weeks after the last dose of investigational product).

This study is currently ongoing, with 225 participants continuing in the open-label extension phase. An analysis of the double-blind phase of the study was performed with a data cutoff date of 25 September 2014.


Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 483 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention
Actual Study Start Date: August 6, 2013
Actual Primary Completion Date: September 25, 2014
Estimated Study Completion Date: November 11, 2019

Arms:
- Placebo Comparator: Placebo
- Experimental: Erenumab 7 mg QM
- Experimental: Erenumab 21 mg QM
- Experimental: Erenumab 70 mg QM