A Study to Test if Fremanezumab is Effective in Preventing Migraine in Children and Adolescents
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Migraine
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 6 years and 17 years
- Gender
- Both males and females
Description
The study population will be composed of 3 subgroups of participants as follows: Participants rolling over from the pivotal Phase 3 pediatric efficacy studies (Studies TV48125-CNS-30082 and TV48125-CNS-30083) Participants rolling over from the Phase 1 pediatric pharmacokinetic study (Study TV48125-C...
The study population will be composed of 3 subgroups of participants as follows: Participants rolling over from the pivotal Phase 3 pediatric efficacy studies (Studies TV48125-CNS-30082 and TV48125-CNS-30083) Participants rolling over from the Phase 1 pediatric pharmacokinetic study (Study TV48125-CNS-10141) Participants rolling over from the pivotal Phase 3 pediatric efficacy studies (Studies TV48125-CNS-30082 and TV48125-CNS-30083) for safety follow-up and antidrug antibody (ADA) evaluation only
Tracking Information
- NCT #
- NCT04530110
- Collaborators
- Not Provided
- Investigators
- Study Director: Teva Medical Expert, MD Teva Pharmaceuticals USA
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