A Multi-center, Randomized, Double-Blind, Placebo-Controlled, Single Dose Efficacy and Safety Study of Staccato® Loxapine for Inhalation in Outpatients With Migraine Headache
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 366
- 试验地点
- 3
- 主要终点
- Pain-Relief at 2 Hours Post-treatment
研究概览
简要总结
Assess the safety and efficacy of Staccato Loxapine in patients with moderate to severe migraine headache with or without aura in an outpatient setting.
详细描述
This study was designed to compare the safety and pharmacodynamic profiles of concomitant administration of single doses of ADASUVE and intramuscular (IM) lorazepam compared to that of each agent administered alone. Respiratory pharmacodynamics were monitored through recordings of respirations/minute and pulse oximetry. Other pharmacodynamic safety measures included effects on blood pressure, heart rate, sedation, and psychomotor measures of attention, information processing speed, reaction time, and coordination.
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
- Triple (Participant, Care Provider, 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Inhaled Placebo
Inhaled Staccato Placebo (0 mg)
干预措施: Inhaled Placebo (Drug)
Inhaled Loxapine 1.25 mg
Inhaled Staccato Loxapine 1.25 mg, single dose
干预措施: Inhaled Loxapine 1.25 mg (Drug)
Inhaled Loxapine 2.5 mg
Inhaled Staccato Loxapine 2.5 mg, single dose
干预措施: Inhaled Loxapine 2.5 mg (Drug)
结局指标
主要结局
Pain-Relief at 2 Hours Post-treatment
时间窗: 2 hours
Pain-Relief=pretreatment pain rating of 2 (moderate) or 3 (severe) and a rating of 0 (none) or 1 (mild) at the designated assessment time
次要结局
- Photophobia Free(2 hours)