NCT00610428已完成2 期
A Multi-center, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of StaccatoTM Prochlorperazine for Inhalation in Patients With Migraine Headache
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Headache Pain Relief at 2 hr Post-dose by 2-point Definition
研究概览
简要总结
Development of Staccato Prochlorperazine for the treatment of migraine headache.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 是
入选标准
- •Subjects who have migraine headache with or without aura (diagnosis according to International Headache Society guidelines) for at least 6 months, who have been pain free for at least 48 hours since the end of their last migraine attack, who have a pain rating of Moderate or Severe prior to dosing.
排除标准
- •Subjects who have taken any other migraine or pain medication within 48 hours of randomization, with a history of allergy or intolerance to phenothiazines and related drugs, or are considered by the investigator, for any reason, to be an unsuitable candidate for receiving prochlorperazine, or unable to use the inhalation device, must be excluded.
研究组 & 干预措施
Inhaled Placebo
Placebo Comparator
Inhaled Staccato Placebo
干预措施: Staccato Placebo (Drug)
Inhaled PCZ 5 mg
Experimental
Inhaled Staccato Prochlorperazine 5 mg
干预措施: Staccato Prochlorperazine 5 mg (Drug)
Inhaled PCZ 10 mg
Placebo Comparator
Inhaled Staccato Prochlorperazine 10 mg
干预措施: Staccato Prochlorperazine 10 mg (Drug)
结局指标
主要结局
Headache Pain Relief at 2 hr Post-dose by 2-point Definition
时间窗: 2 hours after treatment
patient headache pain relief defined as a 2 point reduction as measured on the scale: 0=NO headache pain, 1 = MILD headache pain, 2 = MODERATE headache pain, 3 = SEVERE headache pain
次要结局
- Survival Analysis for Time to Pain Relief(from treatment (time = 0) to 2 hours post treatment)
研究者
研究点 (1)
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