Study ID: TV48125-CNS-30084 | 2019-002056-16
Study Title
- A Study to Test if Fremanezumab is Effective in Preventing Migraine in Children and Adolescents
Teva Identifier
- TV48125-CNS-30084 | 2019-002056-16
ClinicalTrials.gov Identifier
- NCT04530110
Study Status
- Recruiting
Trial Condition(s)
- Migraine
Interventions
- Drug: Fremanezumab
EudractCT 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.
Key Participation Requirements
Gender
- Female, Male
Age Range
- 6 Years to 17 Years
Trial Duration
- September 16, 2020 - May 24, 2024
Phase
- Phase 3
Study Type
Interventional
Location - Where to Participate
You may contact 1-888-483-8279 or email USMedInfo@tevapharm.com to obtain more information about study locations.
