NCT03308968

An Efficacy and Safety Study of Fremanezumab in Adults With Migraine

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 838 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Migraine Prophylaxis

Interventions

Type	Name	Description
DRUG	Fremanezumab	Fremanezumab will be administered per dose and schedule specified in the arm.
DRUG	Placebo	Placebo matching to fremanezumab will be administered per schedule specified in the arm.

Timeline

• Start date: 2017-10-13
• Primary completion: 2018-10-02
• Completion: 2019-05-29
• First posted: 2017-10-13
• Last updated: 2021-11-09
• Results posted: 2019-10-09

Locations

113 sites across 14 countries: United States, Belgium, Czechia, Denmark, Finland, France, Germany, Italy, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study