NCT07116499终止2 期
A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled Crossover Study of K-645 in the Treatment of Multiple Migraine Attacks
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 134
- 试验地点
- 18
- 主要终点
- Percentage of participants with pain freedom
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled, 3-period crossover study to evaluate the safety, tolerability, and efficacy of two dose levels of K-645 in the treatment of patients with acute migraine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
This is a double-blind study where the Sponsor, site staff and participants will be blinded to the treatment assignment.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment Sequence 1
Experimental
干预措施: Placebo (Drug)
Treatment Sequence 1
Experimental
干预措施: K-645 dose level 1 (Drug)
Treatment Sequence 1
Experimental
干预措施: K-645 dose level 2 (Drug)
Treatment Sequence 2
Experimental
干预措施: Placebo (Drug)
Treatment Sequence 2
Experimental
干预措施: K-645 dose level 1 (Drug)
Treatment Sequence 2
Experimental
干预措施: K-645 dose level 2 (Drug)
结局指标
主要结局
Percentage of participants with pain freedom
时间窗: 2 hours post-dose
次要结局
- Percentage of participants with freedom from the most bothersome symptom(2 hours post-dose)
- Percentage of participants who report pain relief(2 hours post-dose)
- Percentage of participants who experienced 1 or more treatment-emergent adverse events (AEs)(up to 7 days after the last dose of study medication)
- Percentage of participants who experienced 1 or more treatment-emergent serious adverse events (SAEs)(up to 7 days after the last dose of study medication)
研究者
研究点 (18)
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