A Multicenter Assessment of ALD403 in Frequent Episodic Migraine (PROMISE 1)

A Multicenter Assessment of ALD403 in Frequent Episodic Migraine (PROMISE 1)

The purpose of this study is to assess ALD403 in the prevention of migraine headache in frequent episodic migraineurs.


Study Type: Interventional (Clinical Trial)
Actual Enrollment: 898 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, Trial to Evaluate the Efficacy and Safety of ALD403 Administered Intravenously in Patients With Frequent Episodic Migraines
Study Start Date: September 2015
Actual Primary Completion Date: February 2017
Actual Study Completion Date: December 2017

Arms:
- Experimental: ALD403 Dose Level 1
- Experimental: ALD403 Dose Level 2
- Experimental: ALD403 Dose Level 3
- Placebo Comparator: Placebo