NCT05458011

A Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Period on Efficacy and Safety of Fremanezumab in Chinese Adults With Migraine

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study With an Open-Label Treatment Period of Fremanezumab Administered Subcutaneously Monthly or Quarterly for the Preventive Treatment of Migraine in Adult Chinese Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 365 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To demonstrate the efficacy of fremanezumab administered as monthly and quarterly subcutaneous (sc) injections to adult Chinese participants with migraine. Secondary Objectives: * To further demonstrate the efficacy of fremanezumab administered as monthly and quarterly sc injections. * To evaluate the safety and tolerability of fremanezumab administered as monthly and quarterly sc injections.

Detailed description

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.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Fremanezumab	Pharmaceutical form: solution for injection Route of administration: subcutaneous injection
DRUG	Placebo	Pharmaceutical form: solution for injection Route of administration: subcutaneous injection

Timeline

• Start date: 2022-09-30
• Primary completion: 2024-01-31
• Completion: 2024-06-13
• First posted: 2022-07-14
• Last updated: 2025-11-26
• Results posted: 2025-01-31

Locations

29 sites across 1 country: China