Merz 完成 XEOMIN 两项全球 III 期偏头痛预防试验患者入组
Merz completes phase 3 recruitment for XEOMIN
Merz Therapeutics 已完成 XEOMIN（incobotulinumtoxinA）用于发作性和慢性偏头痛预防的两项全球 III 期试验患者入组，比计划提前六个月，在北美和欧洲 109 个研究中心共入组约 1800 名成人。MINT-E 和 MINT-C 的主要终点为基线至第 6 个月每月偏头痛天数的变化，次要终点包括每月头痛天数、急性用药天数及每个注射周期末两周内的偏头痛频率。
Global trials assess migraine prevention potential
Merz Therapeutics has completed patient recruitment in two global phase 3 trials evaluating XEOMIN (incobotulinumtoxinA) for the prevention of episodic and chronic migraine.
Recruitment finished six months ahead of schedule, with around 1800 adults enrolled across 109 study sites in North America and Europe. Migraine affects an estimated 1.1 billion people worldwide and represents a significant burden for patients, society and healthcare systems.
Both MINT-E and MINT-C are assessing the change in monthly migraine days from baseline to Month 6 as the primary endpoint.
Secondary endpoints include changes in monthly headache days, acute medication days and migraine frequency during two-week periods at the end of each injection cycle. The studies aim to determine whether XEOMIN can offer a preventive treatment option for adults with episodic or chronic migraine.
Dr Stefan Albrecht said: “Achieving patient recruitment for both MINT-C and MINT-E six months ahead of plan is an important milestone for our XEOMIN migraine prevention program. I am proud of what our teams, investigators and patients have achieved together.”
He added: “With recruitment now complete, our focus is on the main study period and subsequent analysis of the data. These results will guide our next clinical and regulatory decisions as we evaluate XEOMIN for the preventive treatment of chronic and episodic migraine.”
来源：PharmaTimes · pharmatimes.com