NCT02483585

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

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 577 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Erenumab	Administered once a month by subcutaneous injection
DRUG	Placebo	Administered once a month by subcutaneous injection

Timeline

• Start date: 2015-07-20
• Primary completion: 2016-07-11
• Completion: 2017-03-20
• First posted: 2015-06-29
• Last updated: 2022-10-12
• Results posted: 2018-06-25

Locations

76 sites across 8 countries: United States, Denmark, France, Greece, Portugal, Russia, Spain, Switzerland