NCT05550207已完成3 期
An Open-Label, Multiple-Dose Evaluation of the Efficacy and Safety of AXS-07 (Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults With a Prior Inadequate Response to an Oral CGRP Inhibitor
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Percentage of subjects with headache pain relief
研究概览
简要总结
This is a multicenter, open-label trial to evaluate the efficacy and safety of AXS-07 in subjects with migraine attacks and prior inadequate response to oral CGRP inhibitors.
详细描述
Eligible subjects will receive open-label AXS-07 for up to 8 weeks for at-home treatment of their next 4 migraine attacks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has an established diagnosis of migraine with or without aura
- •Has experienced an inadequate response to oral CGRP inhibitors for the acute treatment of migraine
排除标准
- •Pregnant, breastfeeding, or planning to become pregnant during the study
- •Has previously received any investigational drug or device or investigational therapy within 30 days before Screening
研究组 & 干预措施
AXS-07 (meloxicam-rizatriptan)
Experimental
Up to 8 weeks
干预措施: AXS-07 (meloxicam-rizatriptan) (Drug)
结局指标
主要结局
Percentage of subjects with headache pain relief
时间窗: Hour 2 following dose administration
Absence of headache pain and without the use of rescue medication.
Percentage of subjects with absence of the Most Bothersome Symptom
时间窗: Hour 2 following dose administration
Absence of the most bothersome symptom, defined at the onset of migraine.
次要结局
未报告次要终点
研究者
研究点 (1)
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