Study to Test if Fremanezumab is Effective in Preventing Migraine in Children and Adolescents
- Study Title
- 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
- Active, not recruiting
- Trial Condition(s)
- Migraine
- Interventions
- Drug: Fremanezumab
- EudraCT Number
- 2019-002056-16
- Study Description
- Primary objectives: 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: 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 group
- Child
- Age Range
- 6 Years to 17 Years
- Trial Duration
- September 16, 2020 - March 21, 2026
- Phase
- Phase 3
