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Clinical trial

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

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Last updated:19th Jul 2015
Identifier: NCT02483585

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

- Placebo Comparator:
- Experimental: Erenumab

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

Category Value
Date last updated at source 2018-08-08
Study type(s) Interventional
Expected enrolment 577
Study start date 2015-07-19
Estimated primary completion date 2016-07-11

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