Efficacy and Safety of Fremanezumab in Chinese Adults With Migraine

Study Title
A Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Period on Efficacy and Safety of Fremanezumab in Chinese Adults With Migraine
Teva Identifier
TV48125-CNS-30088
ClinicalTrials.gov Identifier
NCT05458011
Study Status
Completed
Trial Condition(s)
Migraine Headache
Interventions
Drug: Fremanezumab | Drug: Placebo

Study Description

The primary Objective is to demonstrate the efficacy of fremanezumab administered as monthly and quarterly subcutaneous (sc) injections to adult Chinese participants with migraine. The secondary Objectives are to further demonstrate the efficacy of fremanezumab administered as monthly and quarterly sc injections and to evaluate the safety and tolerability of fremanezumab administered as monthly and quarterly sc injections. The total study duration for participants is planned to be approximately 9 months. The study will consist of a screening visit, a baseline period (4 weeks), a 12-week double-blind treatment period, a 12-week open-label treatment period, and a follow-up period lasting approximately 3 months after the last dose of treatment.




Key Participation Requirements

Gender
Female, Male
Age Range
Adult
Trial Duration
August 23, 2022 - June 13, 2024
Phase
Phase 3

Study Type

Interventional