NCT04530110

A Study to Test if Fremanezumab is Effective in Preventing Migraine in Children and Adolescents

A Multicenter, Open-Label Study Evaluating the Long-Term Safety, Tolerability, and Efficacy of Monthly Subcutaneous Administration of Fremanezumab for the Preventive Treatment of Episodic and Chronic Migraine in Pediatric Patients 6 to 17 Years of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 506 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D LLC · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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 84 months.

Detailed 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-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

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Fremanezumab	Participants weighing ≥ threshold will receive Dose A subcutaneously monthly. Participants weighing \< threshold will receive Dose B subcutaneously monthly. Subcutaneously monthly, confirmed or adjusted, as appropriate, based on the participant's weight every 3 months.

Timeline

• Start date: 2020-09-16
• Primary completion: 2025-08-15
• Completion: 2025-12-22
• First posted: 2020-08-28
• Last updated: 2026-02-13

Locations

70 sites across 9 countries: United States, Canada, Finland, Germany, Israel, Italy, Netherlands, Poland, Spain

Regulatory

• FDA-regulated drug study