Fremanezumab vs placebo for migraine prevention in patients with documented failure to up to four migraine preventive medication classes (FOCUS): A randomized, double-blind, placebo-controlled, phase 3b trial
The Lancet Sep 28, 2019
Ferrari MD, Diener HC, Ning X, et al. - Through a randomized, double-blind, placebo-controlled, parallel-group, phase 3b FOCUS trial conducted at 104 sites across Belgium, the Czech Republic, Denmark, Finland, France, Germany, Italy, the Netherlands, Poland, Spain, Sweden, Switzerland, the UK, and the USA of 838 individuals aged 18–70 years with episodic or chronic migraine who had documented failure to two to four classes of migraine preventive medications in the past 10 years, experts examined the efficiency and tolerability of fremanezumab, a fully humanized calcitonin gene-related peptide antibody, in patients with migraine who had formerly no response to two to four classes of migraine preventive medications. With quarterly fremanezumab and with monthly fremanezumab, decreases from baseline in monthly average migraine days over 12 weeks were larger in comparison with placebo. For both placebo and fremanezumab, adverse events were comparable. In four of 277 individuals with placebo, two of 276 with quarterly fremanezumab, and four of 285 with monthly fremanezumab, severe adverse events were listed. Thus, in patients with difficult-to-treat migraine who had formerly not responded to up to four classes of migraine preventive medications, fremanezumab was concluded as efficient and well-tolerated.
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