Study to Test if Fremanezumab is Effective in Preventing Chronic Migraine in Patients 6 to 17 Years

Study Title

A Study to Test if Fremanezumab is Effective in Preventing Chronic Migraine in Patients 6 to 17 Years of Age

Teva Identifier

TV48125-CNS-30082

ClinicalTrials.gov Identifier

NCT04464707

Study Status

Recruiting

Trial Condition(s)

Migraine

Interventions

Drug: Fremanezumab | Drug: Placebo

EudraCT Number

2019-002053-33

Study Description

The primary objective of the study is to evaluate the effectiveness of fremanezumab as compared to placebo for the preventive treatment of chronic migraine (CM).

Secondary objectives are to further demonstrate the efficacy of Fremanezumab as compared to placebo for the preventive treatment of CM, to evaluate the safety and tolerability of Fremanezumab in the preventive treatment of CM and to evaluate the immunogenicity of Fremanezumab and the impact of antidrug antibodies (ADAs) on clinical outcomes in participants exposed to Fremanezumab

The total duration of the study is planned to be 48 months.

Click for participation criteria and map of study locations
EudraCT Link

Key Participation Requirements

Gender

Female, Male

Age Range

6 Years to 17 Years

Trial Duration

July 30, 2020 - February 22, 2025

Phase

Phase 3

Study Type

Interventional