At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Fremanezumab and Placebo for Migraine. Completed, enrolled 235 participants across 89 sites in 9 countries.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
Participants weighing \<threshold weight will receive fremanezumab SC at dose A for 3 months.
Participants weighing ≥threshold weight will receive fremanezumab SC at dose B for 3 months.
Matching placebo
Interventions
Dose A or Dose B subcutaneous
Matching placebo