Study ID: TV48125-CNS-30088

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

Not yet recruiting

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

Phase

Phase 3

Study Type

Interventional