MedTrace Logo

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

NCT05458011 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 365

Last updated 2025-11-26

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Fremanezumab

Pharmaceutical form: solution for injection Route of administration: subcutaneous injection

DRUG

Placebo

Pharmaceutical form: solution for injection Route of administration: subcutaneous injection

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Principal Investigators

  • Teva Medical Expert, MD · Teva Branded Pharmaceutical Products R&D, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2024-01-31
Completion
2024-06-13

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05458011 on ClinicalTrials.gov