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
Completed
Trial Condition(s)
Migraine
Interventions
Drug: Fremanezumab | Drug: Placebo
EudraCT Number
2019-002053-33

Study Description

Primary objectives:
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:
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.

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Participation criteria and map of study locations

EudraCT


Key Participation Requirements

Gender
Female, Male
Age group
Child
Age Range
6 Years to 17 Years
Trial Duration
July 30, 2020 - November 29, 2024
Phase
Phase 3

Study Type

Interventional