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). The 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.
Key Participation Requirements
- Gender
- Female, Male
- Age group
- Child
- Age Range
- 6 Years to 17 Years
- Trial Duration
- September 24, 2020 - November 29, 2024
- Phase
- Phase 3
