Zolmitriptan Nasal Spray VS Eletriptan in the Acute Treatment of Migraine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Reduction of migraine headache pain from mild, moderate or severe to pain free.
研究概览
简要总结
The purpose of this study is to Compare the efficacy of zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet in the acute treatment of migraine.
To develop and evaluate a set of importance weights for a predefined set of treatment attributes for migraine suffers using zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet.
To contrast the efficacy of zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet at early time points.
To analyze the patterns of self-reported tolerability of migraine sufferers using zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet.
详细描述
An open-label, randomized, cross-over study comparing the efficacy of zolmitriptan 5 mg nasal spray with eletriptan 40 mg tablet at early time points. Satisfaction endpoints include global assessment of preference, overall satisfaction and effectiveness as well as tolerability of both medications.
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
- None
入排标准
- 年龄范围
- 15 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •15 to 70 years old
- •Migraine attacks according to the criteria proposed by the IHS
- •3-12 Migraine attacks per month
- •adequate contraception
- •Willing and able to give written informed consent
- •Willing and able to complete the entire course of the study & comply with instructions
- •Stable dose of preventive medication for at least 4 weeks
排除标准
- •Disorders listen in groups 5-11 of the IHS Classification
- •Subject is pregnant or lactating.
- •Significant medical or psychiatric disease
- •Subject has a history of symptoms suggestive of ischemic heart disease (angina, myocardial infarction, documented silent ischemia) or other vascular disease, including Prinzmetal angina, claudication, Wolff-Parkinson-White syndrome, or other cardiac accessory conduction pathway arrhythmia
- •Subject has uncontrolled hypertension.
- •Subject has history of basilar, ophthalmoplegic, or hemiplegic migraine or serious neurologic condition associated with headache
- •Subject has used monoamine oxidase A inhibitors (MAOI-As) within 2 weeks of randomization
- •Subject has had serious adverse event while using another 5-HT agonist, or previous serious adverse event while using zolmitriptan or hypersensitivity to zolmitriptan or eletriptan
- •Using CYP3A4 inhibitors listed by the FDA as contraindicated with eletriptan
- •Moderate/severe hepatic/renal impairment
- •Subject currently using cimetidine
- •Concomitant medication treatment with a triptan, ergotamine or methysergide.
研究组 & 干预措施
Zolmitriptan 5 mg nasal spray
干预措施: Zolmitriptan 5 mg Nasal Spray (Drug)
Zolmitriptan 5 mg nasal spray
干预措施: Eletriptan 40 mg tablet (Drug)
Eletriptan 40 mg Tablet
干预措施: Zolmitriptan 5 mg Nasal Spray (Drug)
Eletriptan 40 mg Tablet
干预措施: Eletriptan 40 mg tablet (Drug)
结局指标
主要结局
Reduction of migraine headache pain from mild, moderate or severe to pain free.
时间窗: 30 minutes post-dose
次要结局
- Reduction of migraine headache pain from mild, moderate or severe to pain free.(15 minutes post-dose)