NCT00334178已完成3 期
A Multi-Center, Randomized, Parallel, Double-Blind, Placebo-Controlled Study in Evaluation the Efficacy and Safety of Laxymig® ER as Prophylactic Treatment in Patients With Migraine
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 7
- 主要终点
- change from baseline in the frequency of migraine attacks
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Laxymig® ER compared with placebo in prophylactic monotherapy treatment of migraine headache.
详细描述
The purpose of this study is to evaluate the efficacy and safety of Laxymig® ER compared with placebo in prophylactic monotherapy treatment of migraine headache.
Four weeks baseline, following with 12 weeks treatment phase. Subjects migraine are recorded by diary cards and re-evaluated by the investigator.
Subject will have visit every 4-week (+/- 7 days).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Clinical diagnosis of migraine with or without aura (typical aura with migraine headache)
- •Subjects who had an average of two or more migraine frequencies per month during the 3 months before screening
排除标准
- •Female subjects who are pregnant, lactating
- •Chronic daily headache
- •Previous treatment with three or more migraine prophylaxis medications failed
- •Subjects with hepatic disease whose liver enzymes are over 2 times of upper limit of reference or significant dysfunction
- •Coexisting medical, neurological, or psychiatric disorder that may hinder the study according to the investigator's judgment
结局指标
主要结局
change from baseline in the frequency of migraine attacks
次要结局
- change from baseline in 4-week in migraine periods of week 9 to 12;
- change from baseline in 4-week in migraine days of week 9 to 12;
- the proportion of subjects with a reduction of 50% or more in 4-week migraine frequencies;
- the proportion of subjects with a reduction of 50% or more in 4-week migraine periods;
- the proportion of subjects with a reduction of 50% or more in 4-week migraine days
- the average symptomatic medications usage
研究者
研究点 (7)
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