Efficacy of Topiramate in Patients Wih Migraine-Associated Dizziness
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in Dizziness Handicap Inventory scores from baseline.
研究概览
简要总结
The purpose of this study is to determine whether topiramate effective in treating dizziness symptoms that are associated with migraine headaches.
详细描述
Migraine is a common disorder, often associated with dizziness symptoms. In many cases, dizziness is one of the only manifestations of migraine headaches. Various classes of drugs have been advocated as treatment for migraine-associated dizziness, though none has been shown to be superior over the others.
Topiramate is a drug approved for migraine prophylaxis. This study is designed to assess if there are significant changes in dizziness frequency and severity in patients diagnosed with migraine-associated dizziness treated with topiramate. Demonstrating benefit of topiramate with a placebo-controlled study to alleviate symptoms of dizziness would serve to clarify effective treatment options for patients with migraine-associated dizziness.
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
- 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-associated dizziness.
排除标准
- •Previous or current use of topiramate prior to study enrollment.
- •Need for continued use of the following medications for any medical reason during the study: ergots, anti-epileptics, beta-blockers, calcium channel blockers, monoamine oxidase inhibitors, high-dose magnesium, high-dose riboflavin, corticosteroids, local anesthetics, botulinum toxin, or herbal preparations.
- •History of nephrolithiasis.
- •Women whom are pregnant or breastfeeding.
- •Patients with known sensitivity to topiramate.
- •Patients with a history of glaucoma.
- •Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study.
研究组 & 干预措施
2
1 placebo pill orally for 2 weeks, then 2 placebo pills orally for 6 weeks
干预措施: lactulose placebo pill (Drug)
topiramate
topiramate 50mg orally for 2 weeks, then 100mg orally for 6 weeks
干预措施: topiramate (Drug)
结局指标
主要结局
Change in Dizziness Handicap Inventory scores from baseline.
时间窗: 4 weeks, 8 weeks
Change in mean 28-day monthly vertigo frequency from baseline.
时间窗: 4 weeks, 8 weeks
次要结局
- Change in an individual's perception of vertigo symptoms based on a 1 to 10 scale.(4 weeks, 8 weeks)