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.

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EudraCT Link


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