NCT04458857

A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy, Safety, and Tolerability of Subcutaneous Administration of Fremanezumab Versus Placebo for the Preventive Treatment of Episodic Migraine in Pediatric Patients 6 to 17 Years of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 235 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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 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.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Fremanezumab	Dose A or Dose B subcutaneous
DRUG	Placebo	Matching placebo

Timeline

• Start date: 2020-07-15
• Primary completion: 2024-03-13
• Completion: 2024-03-13
• First posted: 2020-07-07
• Last updated: 2025-06-22
• Results posted: 2025-04-16

Locations

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

Regulatory

• FDA-regulated drug study