Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) Compared to Placebo in Migraine Prevention (ARISE)
To evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days, in adults with episodic migraine.
Adults with a history of migraine with or without aura for ≥ 12 months and who experience ≥ 4 to < 15 migraine days per month with < 15 headache days per month will be randomized 1:1 to placebo or erenumab. Double-blind erenumab or placebo will be administered during the 12-week double-blind treatment phase and open-label erenumab will be administered during the 28-week open-label treatment phase.
Study Type: Interventional (Clinical Trial)
Actual Enrollment: 577 participants
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention
Actual Study Start Date: July 19, 2015
Actual Primary Completion Date: July 11, 2016
Actual Study Completion Date: March 20, 2017
- Placebo Comparator: Placebo
- Experimental: Erenumab
- ARISE: A Phase 3 randomized trial of erenumab for episodic migraine.
|Date last updated at source||2018-08-08|
|Study start date||2015-07-19|
|Estimated primary completion date||2016-07-11|