NCT00617747已完成3 期
A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel Group Trial to Evaluate Early Efficacy and Tolerability of Zolmitriptan (ZOMIG) Nasal Spray in the Acute Treatment of Adult Subjects With Migraine.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 2,114
- 主要终点
- Improvement in migraine headache pain from severe or moderate to mild or none
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and tolerability (the ability not to experience ill effects from the study drug) of a zolmitriptan nasal spray, 5.0 mg, compared with placebo (inactive drug) for 2 migraine headaches for up to 12 weeks in adult subjects with migraine headaches
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
- •Subject has an established diagnosis of migraine headache, with or without aura
- •Subject has a medical history indicating the presence of migraine attacks for at least 1 year before the start of the trial or a minimum of 2 and maximum of 6 migraine attacks per month on average for 3 months preceding the study
- •Subject has non migraine headaches on fewer than 6 days each month for 3 months preceding the study
排除标准
- •Subject has history of basilar, ophthalmoplegic or hemiplegic migraine or serious neurologic condition associated with headache
- •Subject has used a MAOI within 2 weeks of randomisation or has been given SSRI therapy or migraine prophylactic agent within 3 months of randomisation. Subject requires treatment with propranolol or cimetidine or has had an intolerable or serious adverse event while using another triptan
- •Subject has a history or symptoms suggestive of ischemic heart disease, coronary artery vasospasm or other significant underlying cardiovascular disease or clinically significant abnormalities seen on an ECG or uncontrolled hypertension
研究组 & 干预措施
1
Experimental
干预措施: Zolmitriptan (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Improvement in migraine headache pain from severe or moderate to mild or none
时间窗: 15 minutes after the initial dose of trial treatment
次要结局
- Headache response rate(30 minutes and 1, 2 and 4 hours after dosing)
研究者
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