NCT01211145已完成4 期
A Multicenter, Double-blind, Randomized, Placebo-controlled, 4-Armed Parallel Group Study to Evaluate the Efficacy of Zolmitriptan 0.5-, 2.5- and 5-mg Nasal Spray in the Treatment of Acute Migraine Headache in Adolescents
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,653
- 试验地点
- 1
- 主要终点
- Pain-free Status at 2 Hours Post-treatment
研究概览
简要总结
The purpose of this study is to investigate if Zomig® Nasal Spray will help children (age 12-17 years) with migraine headaches feel better. This will be done by comparing 3 different doses of Zomig Nasal Spray with placebo nasal spray (inactive treatment).
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
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of written informed consent by parent or legal guardian, and written assent provided by patient prior to any study specific procedures.
- •Established diagnosis of migraine.
- •History of a minimum of 2 migraine attacks (moderately or severely disabling)per month.
排除标准
- •Any medical condition that may put the patient at increased risk with exposure to zolmitriptan or that may interfere with the safety or efficacy assessments.
- •A history of basilar, ophthalmoplegic, or hemiplegic migraine headache or any potentially serious neurological condition that is associated with headache.
- •Have had an unacceptable adverse experience following previous use of any 5HT1B/1D agonist drug.
研究组 & 干预措施
1
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
2
Experimental
ZOMIG 0.5 mg
干预措施: Zolmitriptan (Drug)
3
Experimental
ZOMIG 2.5 mg
干预措施: Zolmitriptan (Drug)
4
Experimental
ZOMIG 5.0 mg
干预措施: Zolmitriptan (Drug)
结局指标
主要结局
Pain-free Status at 2 Hours Post-treatment
时间窗: 2 hours post-treatment.
次要结局
- Pain-free Status at 24 Hours Post-treatment(24 hours post-treatment)
- Headache Response at 2 Hours Post-treatment(2 hours post-treatment)
- Headache Response at 24 Hours Post-treatment(24 hours post-treatment)
- Sustained Headache Response at 2 Hours(Up to 2 hours post-treatment)
- Use of Rescue Medication During the First 24 Hours After Treatment(24 hours post-treatment.)
研究者
研究点 (1)
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