5 results
There will be three formal interim analyses during the study. Interim Analysis 1 will occur at the end of Phase II when approximately 162 PFS events (defined as disease progression or death due to any cause, whichever occurs first) have been…
Primary: -The correlation between 18F-choline uptake in the atherosclerotic plaques on PET-MRI and plaque inflammation on histology, including the content of CD68-positive activated monocytes/macrophages.Secondary: -The correlation between the…
Main objective:To evaluate the efficacy of fremanezumab as compared to placebo for the preventive treatment of episodic migraine (EM)Secondary objectives:-To evaluate the safety and tolerability of fremanezumab in the preventive treatment of…
Main objective:The primary objective of the trial is to evaluate the efficacy of test investigational medicinal product (IMP) as compared to placebo IMP for the preventive treatment of chronic migraine (CM). Secondary objectives:To evaluate the…
Main objective:To evaluate the long-term safety and tolerability of subcutaneous test IMP in the preventive treatment of migraine in pediatric participants 6 to 17 years of age (inclusive at enrollment in the pivotal trial)Secondary objectives:-To…