An Efficacy and Safety Study of Fremanezumab in Adults With Migraine — FOCUS  

Migraine Prophylaxis Clinical Trial

Official title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study With an Open-Label Period to Evaluate the Efficacy and Safety of Fremanezumab for the Prophylactic Treatment of Migraine in Patients With Inadequate Response to Prior Preventive Treatments

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of monthly and quarterly subcutaneous (sc) injections of fremanezumab compared with sc injections of placebo in participants with chronic migraine (CM) or episodic migraine (EM) who have responded inadequately to 2 to 4 classes of prior preventive treatments. Approximately equal numbers of participants from each subgroup (CM and EM) are randomized in blinded-fashion 1:1:1 into one of 3 treatments for the subgroup - 2 active treatments and 1 placebo treatment- consisting of monthly injections for 3 months (up to Week 12). Then all participants continue into an open-label extension of 3 months (up to Week 24) during which everyone is administered sc injections of fremanezumab.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Migraine Disorders
• Migraine Prophylaxis

• NCT number: NCT03308968
• Study type: Interventional
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Status: Completed
• Phase: Phase 3
• Start date: October 13, 2017
• Completion date: May 29, 2019