目的:Ubrogepant是一种降钙素基因相关肽受体拮抗剂,被批准用于偏头痛的急性治疗。PRODROME先前的试验表明,在前驱症状期间进行一次性治疗可以预防中度或重度头痛的发作。在对PRODROME试验的分析中,我们评估了前驱症状期间乌布罗吉特治疗对患者报告结局(PRO)的益处.
方法:PRODROME是一个多中心,随机化,双盲,安慰剂对照,交叉试验,纳入每月经历2-8次偏头痛发作并伴有中度-重度头痛的成年人。符合条件的参与者治疗了2个合格的前驱事件,定义为当参与者确信头痛会在1-6小时内出现时,有前驱症状的偏头痛发作。参与者被随机分配到治疗序列A(安慰剂,然后是100毫克)或序列B(100毫克,然后是安慰剂)。该分析评估了在24小时内(次要终点)和在给药后的特定时间点(额外终点)正常发挥功能的能力。其他PRO终点包括24小时内的活动限制和8小时和24小时时对研究药物的满意度。
结果:在518名随机参与者中,477包括修改的意向治疗群体。在治疗合格的前驱事件后,与安慰剂组相比,接受100mg乌布罗吉特治疗的参与者在24小时内的正常功能能力显著增强(比值比[OR]1.66,95%CI1.40~1.96;p<0.0001).早在给药后2小时,接受ubrogepant治疗的参与者报告“没有残疾”的比例更高,与安慰剂相比,能够正常发挥功能(OR1.76,95%CI1.32-2.35;名义p=0.0001)。在前驱症状期间给予Ubrogepant也与剂量后24小时内活动限制的更大降低相关(OR2.07,95%CI1.61-2.67;名义p<0.0001)。在给药后8和24小时,usbrogepant的“满意”或“极度满意”率高于安慰剂(8小时:OR2.37,95%CI1.78-3.15;名义p<0.0001;24小时:OR2.32,95%CI1.78-3.02;名义p<0.0001)。
结论:在前驱期间给予100mg乌布罗吉特与功能正常的能力显着增强有关,活动限制在24小时内减少更多,对研究药物的满意度更高,与安慰剂相比。
■ClinicalTrials.govNCT04492020。送检:2020年7月27日;首例患者登记:2020年8月21日。clinicaltrials.gov/ct2/show/NCT04492020。
方法:这项研究提供了II类证据,证明在偏头痛前驱期间服用100毫克的乌布罗吉特药可使更多患者在接下来的24小时内正常运作。
OBJECTIVE: Ubrogepant is a calcitonin gene-related peptide receptor antagonist approved for the acute treatment of migraine. The PRODROME trial previously demonstrated that ubrogepant treatment during prodrome prevents the onset of moderate or severe headache. In this analysis of the PRODROME trial, the benefits of ubrogepant treatment during the prodrome on patient-reported outcomes (PROs) are evaluated.
METHODS: PRODROME was a multicenter, randomized, double-blind, placebo-controlled, crossover trial that enrolled adults who experienced 2-8 migraine attacks per month with moderate-severe headache pain. Eligible participants treated 2 qualifying prodrome events, defined as a migraine attack with prodromal symptoms when the participant was confident a headache would follow within 1-6 hours. Participants were randomized to treatment sequence A (placebo then ubrogepant 100 mg) or sequence B (ubrogepant 100 mg then placebo). This analysis evaluated the ability to function normally over 24 hours (secondary end point) and at specific time points after dose (additional end point). Other PRO end points included activity limitation over 24 hours and satisfaction with study medication at 8 and 24 hours.
RESULTS: Of 518 randomized participants, 477 comprised the modified intent-to-treat population. After treatment of qualifying prodrome events, a significantly greater ability to function normally over 24 hours was observed for participants after treatment with ubrogepant 100 mg compared with placebo (odds ratio [OR] 1.66, 95% CI 1.40-1.96; p < 0.0001). As early as 2 hours after dose, a greater proportion of ubrogepant-treated participants reported \"no disability, able to function normally\" compared with placebo (OR 1.76, 95% CI 1.32-2.35; nominal p = 0.0001). Ubrogepant administered during the prodrome was also associated with a greater reduction in activity limitations over 24 hours after dose (OR 2.07, 95% CI 1.61-2.67; nominal p < 0.0001). At 8 and 24 hours after dose, rates of being \"satisfied\" or \"extremely satisfied\" were greater for ubrogepant than for placebo (8 hours: OR 2.37, 95% CI 1.78-3.15; nominal p < 0.0001; 24 hours: OR 2.32, 95% CI 1.78-3.02; nominal p < 0.0001).
CONCLUSIONS: Ubrogepant 100 mg administered during the prodrome was associated with significantly greater ability to function normally, greater reduction in activity limitations over 24 hours, and greater satisfaction with study medication, compared with placebo.
UNASSIGNED: ClinicalTrials.gov NCT04492020. Submitted: July 27, 2020; first patient enrolled: August 21, 2020. clinicaltrials.gov/ct2/show/NCT04492020.
METHODS: This study provides Class II evidence that taking ubrogepant 100 mg during a migraine prodrome allows more patients to function normally over the next 24 hours.