Background

Atogepant is an oral, small-molecule, calcitonin gene–related peptide receptor antagonist for the preventive treatment of migraine.

Methods

In the double-blind, phase 3 ADVANCE trial, participants with 4–14 migraine days/month were randomized to atogepant 10 mg, 30 mg, 60 mg, or placebo once daily for 12 weeks. We evaluated the time course of efficacy of atogepant for the preventive treatment of migraine. Analyses included change from baseline in mean monthly migraine days during each of the three 4-week treatment periods, change in weekly migraine days during weeks 1–4, and proportion of participants with a migraine on each day during the first week.

Results

We analyzed 873 participants (n = 214 atogepant 10 mg, n = 223 atogepant 30 mg, n = 222 atogepant 60 mg, n = 214 placebo). For weeks 1–4, mean change from baseline in mean monthly migraine days ranged from −3.1 to −3.9 across atogepant doses vs −1.6 for placebo (p < 0.0001). For weeks 5–8 and 9–12, reductions in mean monthly migraine days ranged from −3.7 to −4.2 for atogepant vs −2.9 for placebo (p ≤ 0.012) and −4.2 to −4.4 for atogepant vs −3.0 for placebo (p < 0.0002), respectively. Mean change from baseline in weekly migraine days in week 1 ranged from −0.77 to −1.03 for atogepant vs −0.29 with placebo (p < 0.0001). Percentages of participants reporting a migraine on post-dose day 1 ranged from 10.8% to 14.1% for atogepant vs 25.2% with placebo (p ≤ 0.0071).

Conclusion

Atogepant demonstrated treatment benefits as early as the first full day after treatment initiation, and sustained efficacy across each 4-week interval during the 12-week treatment period.

Clinical trial registration: ClinicalTrials.gov identifier: NCT03777059

中文翻译：

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atogepant 预防偏头痛的疗效时间过程：随机、双盲 ADVANCE 试验的结果

背景

Atogepant 是一种口服小分子降钙素基因相关肽受体拮抗剂，用于预防偏头痛。

方法

在双盲 3 期 ADVANCE 试验中，患有 4-14 天/月偏头痛的参与者被随机分配到阿托格帕特 10 毫克、30 毫克、60 毫克或安慰剂，每天一次，持续 12 周。我们评估了 atogepant 预防偏头痛的疗效时间过程。分析包括三个 4 周治疗期间每个月平均偏头痛天数与基线的变化、第 1-4 周每周偏头痛天数的变化以及第一周每天偏头痛的参与者比例。

结果

我们分析了 873 名参与者（n = 214 atogepant 10 mg，n = 223 atogepant 30 mg，n = 222 atogepant 60 mg，n = 214 安慰剂）。在第 1-4 周，平均每月偏头痛天数从基线的平均变化范围为 -3.1 至 -3.9，与安慰剂相比为 -1.6（p  < 0.0001）。在第 5-8 周和第 9-12 周，平均每月偏头痛天数的减少范围为 atogepant 的 -3.7 至 -4.2 与安慰剂的 -2.9（p  ≤ 0.012）和 atogepant 的 -4.2 至 -4.4 与安慰剂的 -3.0 （p  < 0.0002)，分别。第 1 周每周偏头痛天数与基线的平均变化范围为 -0.77 至 -1.03，阿托格帕特组与 -0.29 组安慰剂组（p < 0.0001)。在给药后第 1 天报告偏头痛的参与者百分比范围为 10.8% 至 14.1%，安慰剂组为 25.2%（p  ≤ 0.0071）。

结论

Atogepant 早在治疗开始后的第一个全天就显示出治疗益处，并且在 12 周治疗期间的每 4 周间隔内均具有持续疗效。

临床试验注册： ClinicalTrials.gov 标识符：NCT03777059