Overview

An Efficacy and Safety Study of Fremanezumab in Adults With Migraine

Status:
Completed
Trial end date:
2019-05-29
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Teva Branded Pharmaceutical Products, R&D Inc.