NCT02456740

Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) 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: 955 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study was to evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days.

Detailed description

This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial. The trial consisted of four phases: screening (≤ 3 weeks of initial screening and a 4-week baseline phase); the double-blind treatment phase (24 weeks) in which participants received placebo or erenumab 70 mg or 140 mg daily; the active-treatment phase, in which participants underwent repeat randomization and were assigned to receive 70 mg or 140 mg of erenumab (28 weeks); and a safety follow-up phase (12 weeks).

Conditions

• Migraine

Interventions

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

Timeline

• Start date: 2015-07-17
• Primary completion: 2016-09-05
• Completion: 2017-06-19
• First posted: 2015-05-28
• Last updated: 2022-10-12
• Results posted: 2018-07-10

Locations

129 sites across 13 countries: United States, Austria, Belgium, Canada, Czechia, Finland, Germany, Netherlands, Poland, Slovakia, Sweden, Turkey (Türkiye), United Kingdom