NCT00440518已完成2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of 100mg/Day and 300mg/Day Lacosamide for Migraine Prophylaxis.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 218
- 主要终点
- Change From Baseline in Mean Migraine Headache Rates During the Entire 14-week Maintenance Period
研究概览
简要总结
The purpose of this study is to see how safe and effective Lacosamide (LCM) is when taken by mouth, twice a day for up to 18 weeks to prevent migraines.
详细描述
This study is for subjects who have been diagnosed with migraine for at least one year and who are currently taking an effective abortive medication(s).
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
- •History of migraines headaches for 1 year and well documented 3 month retrospective history of migraines.
- •Experience 2-8 migraines per month but not more than 15 headache days per month. There should be at least 48 hours of freedom between headaches.
- •On effective stable abortive medication(s) for the acute treatment of migraine.
排除标准
- •Subject in another investigational drug or device study within the last 30 days or is currently in another investigational drug trial.
- •Use of triptans or ergots for migraine abortive treatment > 2-3 days per calendar week 2 months prior to screening.
- •Experience 15 or more headache days per month of any kind 2 months prior to screening.
- •Has another consistent or chronic form of headache.
- •Unable to stop medications, herbs, vitamins, or minerals used to prevent a migraine from occurring.
- •Pregnant or nursing women and those of child bearing potential who are not surgically sterile, or 2 years post menopausal, or do not practice 2 combined methods of birth control, unless sexually abstinent, during the trial.
- •Significant laboratory or electrocardiograms (ECG) abnormalities
- •Significant medical history including cardiovascular abnormalities.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Other)
Lacosamide 100mg
Experimental
100mg lacosamide
干预措施: Lacosamide (Drug)
Lacosamide 300mg
Experimental
300mg lacosamide
干预措施: Lacosamide (Drug)
结局指标
主要结局
Change From Baseline in Mean Migraine Headache Rates During the Entire 14-week Maintenance Period
时间窗: Baseline, Entire 14-week Maintenance Period
次要结局
- Change From Baseline in Mean Migraine Headache Rates During the Last 4 Weeks of the Maintenance Period(Baseline, last 4 weeks of the 14-week Maintenance Period)
- Number of Subjects Who Experience a 50 Percent or Greater Reduction From Baseline in Migraine Frequency During the Last 4 Weeks of the Maintenance Period.(Baseline, last 4 weeks of the 14-week Maintenance Period)
- Changes From Baseline in Improvement of Function and Reduction of Disability Using the Headache Impact Test (HIT-6)(Baseline, last visit in the 17-week Trial Period)
- Number of Subjects Who Experience a 50 Percent or Greater Reduction From Baseline in Migraine Frequency During the Entire 14-week Maintenance Period.(Baseline, Entire 14-week Maintenance Period)
研究者
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