Evaluation of ALD403 (Eptinezumab) in the Prevention of Chronic Migraine (PROMISE 2)

Evaluation of ALD403 (Eptinezumab) in the Prevention of Chronic Migraine (PROMISE 2)

The purpose of this study is to assess the efficacy and safety of ALD403 in the prevention of migraine headache in chronic migraineurs.


Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 1121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Parallel Group, Double-Blind, Randomized, Placebo Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of ALD403 Administered Intravenously in Patients With Chronic Migraine
Actual Study Start Date: November 2016
Actual Primary Completion Date: November 2017
Actual Study Completion Date: April 2018

Arms:
- Experimental: ALD403 (Eptinezumab) Dose Level 1
- Experimental: ALD403 (Eptinezumab) Dose Level 2
- Placebo Comparator: Placebo