Fremanezumab for the preventive treatment of migraine in Chinese adults: A Phase 3, randomized controlled trial with an open-label extension
Abstract
Aim Fremanezumab is approved for migraine prevention in Europe, the United States (US), Japan, South Korea, and several other countries; however, there are no data available on fremanezumab as a migraine preventive treatment in a Chinese population. This study evaluated the efficacy and safety of fremanezumab in Chinese adults with migraine. Methods This randomized, multicenter, Phase 3 trial consisted of a 4-week screening period, a 12-week double-blind period (DBP), and a 12-week open-label extension (OLE). Chinese adults with episodic and chronic migraine were randomized 1:1:2 to receive fremanezumab monthly (225 mg), fremanezumab quarterly (675 mg), or matched monthly placebo during the DBP. During the OLE, all participants received fremanezumab monthly (225 mg). The primary endpoint was mean change from baseline in monthly migraine days (MMD) during the DBP. Secondary endpoints included mean change from baseline in migraine days during the first 4 weeks of treatment and in monthly number of days with acute headache medication use during the DBP. Similar endpoints were assessed during the OLE. Safety assessments included, but were not limited to, adverse event (AE) reporting. Results In total, 365/454 screened participants were randomized to fremanezumab (n = 182 [monthly, n = 91; quarterly, n = 91]) or placebo (n = 183). Significantly greater changes from baseline in MMD were observed with fremanezumab versus placebo during the DBP (−4.6 vs −2.8; p < 0.0001) and in mean…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 454 participants or records.
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