An Open-Label, Long-Term Study to Assess the Safety and Efficacy of AXS-07 (MoSEIC™ 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
- 706
- 试验地点
- 1
- 主要终点
- Long-term Safety of Chronic Intermittent Use of AXS-07
研究概览
简要总结
MOVEMENT (Multimechanistic Treatment over Time of Migraine Symptoms) is a Phase 3 study to evaluate the long-term safety of chronic intermittent use of AXS-07 and to assess the effect of AXS-07 on migraine symptoms following repeated treatment of migraine attacks.
详细描述
This study is a Phase 3, multicenter, open-label, trial to evaluate the long-term safety and efficacy of intermittent chronic dosing with AXS-07 in subjects with migraine attacks. Eligible subjects will take AXS-07 following the onset of a migraine. Subjects will be treated for up to 12 months.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has participated in a prior study with AXS-07 for the treatment of migraine
排除标准
- •Has previously received any investigational drug or device or investigational therapy within 30 days before Screening, other than AXS-07
- •Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
研究组 & 干预措施
AXS-07
干预措施: AXS-07 (Drug)
结局指标
主要结局
Long-term Safety of Chronic Intermittent Use of AXS-07
时间窗: Up to 12 months
Long-term safety as measured by: Subjects with any TEAEs Subjects with suspected to be drug-related TEAEs Subjects with serious TEAEs Subjects with TEAEs that led to drug withdrawal Subjects with TEAEs that led to withdrawal from study Subjects with TEAEs that resulted in death
次要结局
未报告次要终点