Study to Test if Fremanezumab is Effective in Preventing Migraine in Children and Adolescents

Study Title

A Study to Test if Fremanezumab is Effective in Preventing Migraine in Children and Adolescents

Teva Identifier

TV48125-CNS-30084

ClinicalTrials.gov Identifier

NCT04530110

Study Status

Recruiting

Trial Condition(s)

Migraine

Interventions

Drug: Fremanezumab

EudraCT Number

2019-002056-16

Study Description

The primary objective of the study is to evaluate the long-term safety and tolerability of subcutaneous fremanezumab in the preventive treatment of migraine in pediatric participants 6 to 17 years of age (inclusive at enrollment in the pivotal study).

Secondary objectives are to evaluate the efficacy of subcutaneous fremanezumab in pediatric participants with migraine and to evaluate the immunogenicity of fremanezumab and the impact of ADAs on clinical outcomes in pediatric participants exposed to fremanezumab.

The total duration of the study is planned to be up to 60 months.


Key Participation Requirements

Gender

Female, Male

Age Range

6 Years to 17 Years

Trial Duration

September 16, 2020 - March 21, 2026

Phase

Phase 3

Study Type

Interventional