MOMENTUM: A Randomized, Double-blind, Single-dose, Placebo-controlled Study to Assess the Efficacy and Safety of AXS-07 (Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,594
- 试验地点
- 1
- 主要终点
- Percentage of Subjects Reporting Headache Pain Freedom
研究概览
简要总结
AXS-07 is an oral, investigational medicine consisting of MoSEIC meloxicam and rizatriptan, which is being developed for the acute treatment of migraine with or without aura in adults. AXS-07 tablets are formulated to provide an enhanced rate of absorption of meloxicam. This study is designed to evaluate the efficacy and safety of AXS-07 compared to meloxicam, rizatriptan, and placebo for the treatment of a migraine attack.
This is a randomized, double-blind, 4-arm, parallel group, single-dose, placebo-controlled trial. Subjects who successfully complete screening and continue to meet all entry criteria will be randomly assigned to take one dose of either AXS-07, meloxicam, rizatriptan, or placebo upon the occurrence of a qualifying migraine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（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 prior acute treatments.
排除标准
- •Has previously received any investigational drug or device or investigational therapy within 30 days before Screening.
- •Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.
研究组 & 干预措施
AXS-07
Taken once upon a qualifying migraine
干预措施: AXS-07 (MoSEIC meloxicam and rizatriptan) (Drug)
Meloxicam
Taken once upon a qualifying migraine
干预措施: Meloxicam (Drug)
Rizatriptan
Taken once upon a qualifying migraine
干预措施: Rizatriptan (Drug)
Placebo
Taken once upon a qualifying migraine
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Subjects Reporting Headache Pain Freedom
时间窗: Hour 2 following dose administration
Absence of headache pain. AXS-07 vs Placebo.
Percentage of Subjects With Absence of Most Bothersome Symptom
时间窗: Hour 2 following dose administration
Absence of most bothersome symptom, defined at the onset of migraine. AXS-07 vs Placebo.
次要结局
未报告次要终点