A Randomized, Double Blind, Placebo Controlled, Parallel Group, Phase 3 Study of MAP0004 in Adult Migraineurs for a Single Migraine Followed by Open Label Extension.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 902
- 试验地点
- 1
- 主要终点
- Number of Subjects Nausea Free at 2 Hours From Time of First Dose
研究概览
简要总结
This is a randomized, double blind, placebo controlled, parallel group study of MAP0004 in adult migraineurs. Subjects will self administer study drug in the outpatient setting.
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
- 否
入选标准
- •Male or female between 18 and 65 years of age.
- •History of episodic, acute migraine (with or without aura) with onset prior to 50
排除标准
- •Known allergy or sensitivity or contraindication to study drugs or their formulations
- •History of chronic pulmonary disease, coronary artery disease (CAD), liver disease, kidney disease, seizures, stroke, or major psychiatric condition.
- •Any condition that, in the opinion of the Investigator, would make the subject unsuitable for study participation
研究组 & 干预措施
MAP0004
MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
干预措施: MAP0004 (Drug)
Placebo
Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to 52 weeks.
干预措施: MAP0004 (Drug)
Placebo
Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to 52 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Subjects Nausea Free at 2 Hours From Time of First Dose
时间窗: 2 hours from time of first dose
Nausea free was defined as a rating of none (score 0) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours post-dose. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
Number of Subjects With Pain Relief at 2 Hours From Time of First Dose
时间窗: 2 hours from time of first dose
Pain relief at 2 hours was defined as change in rating from severe or moderate (score 3 or 2) to a rating of none or mild (score 0 or 1) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
Number of Subjects Photophobia Free at 2 Hours From Time of First Dose
时间窗: 2 hours from time of first dose
Photophobia free at 2 hours was defined as a rating of none (score 0) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
Number of Subjects Phonophobia Free at 2 Hours From Time of First Dose
时间窗: 2 hours from time of first dose
Phonophobia free at 2 hours was defined as a rating of none (score 0) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
次要结局
- Number of Subjects With Sustained Pain Relief From 2 to 24 Hours(From 2 to 24 hours from time of first dose)
- Number of Subjects Whose Time to Pain Relief Occurred Within 2 Hours(2 hours from the first dose)
- Number of Subjects With Pain Relief at 4 Hours(4 hours from time of first dose)
- Number of Subjects With Pain Relief at 10 Minutes(2 hours from time of first dose)