Data from Clinicaltrials.gov - Curated by EPG Health - Last updated 02 April 2019

To evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days, in adults with episodic migraine.

purpose

Brief Summary:
To evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days, in adults with episodic migraine.

Detailed Description:
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
Allocation: Randomized
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

Arm:
- Placebo Comparator:
Placebo
- Experimental: Erenumab


Related journal:
- ARISE: A Phase 3 randomized trial of erenumab for episodic migraine.

Category Value
Date last updated at source 08-Aug-18
Study type(s) Interventional
Expected enrolment 577
Study start date 19-Jul-15
Estimated primary completion date 11-Jul-16

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