NCT03812224

A Controlled Trial of Erenumab in Migraine Prevention

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 261 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to assess the efficacy and safety of erenumab for prevention of migraine in Japanese adults with episodic migraine (EM) and chronic migraine (CM).

Detailed description

Migraine prevention is an area of a large unmet medical need, with existing therapies often having modest efficacy and poor tolerability. Calcitonin gene-related peptide (CGRP) receptor antagonism is a novel approach to migraine preventive therapy. Erenumab is a human monoclonal antibody against canonical CGRP receptor. The present study is a phase 3 trial intended to assess the efficacy and safety of erenumab for prevention of migraine in Japanese adults with episodic migraine (EM) and chronic migraine (CM). The study consists of a screening period (up to 7 weeks, including a 4-week baseline period), a 24-week double-blind treatment period (DBTP), a 28-week open-label treatment period (OLTP), and an 8-week safety follow-up period (12 weeks after the last dose of investigational product).

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: 2019-04-12
• Primary completion: 2020-03-16
• Completion: 2020-11-25
• First posted: 2019-01-23
• Last updated: 2024-02-21
• Results posted: 2021-03-04

Locations

41 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study