Fremanezumab in Preventing Episodic Migraine in Patients 6 to 17 Years of Age
- Study Title
- A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age
- Teva Identifier
- TV48125-CNS-30083
- ClinicalTrials.gov Identifier
- NCT04458857
- Study Status
- Completed
- Trial Condition(s)
- Migraine
- Interventions
- Drug: Fremanezumab | Drug: Placebo
- EudraCT Number
- 2019-002055-42
- Study Description
- Primary objectives: The primary objective of the study is to evaluate the efficacy of fremanezumab as compared to placebo for the preventive treatment of episodic migraine (EM). Secondary objectives: Secondary objectives are to further demonstrate the efficacy of Fremanezumab as compared to placebo for the preventive treatment of EM, to evaluate the safety and tolerability of Fremanezumab in the preventive treatment of EM 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 up to 51 months
Key Participation Requirements
- Gender
- Female, Male
- Age group
- Child
- Age Range
- 6 Years to 17 Years
- Trial Duration
- July 15, 2020 - March 13, 2024
- Phase
- Phase 3
