EUCTR2015-001222-42-Outside-EU/EEA进行中（未招募）不适用
A double-blind trial comparing the efficacy, tolerability and safety of monotherapy topiramate versus phenytoin in subjects with seizures indicative of new onset epilepsy
Johnson & Johnson Pharmaceutical Research and Development, L.L.C.0 个研究点目标入组 261 人开始时间: 2015年4月24日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 261
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Seizures indicative of new-onset epilepsy (or epilepsy relapse) of untreated epilepsy
- •- at least one but not more than 20 unprovoked seizures within past 3 months
- •- weighing more than 110 pounds
- •- considered to be a good candidate for rapid initiation of anti-seizure medication
- •- able to swallow a tablet whole (without crushing it).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 262
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 262
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 262
排除标准
- •- Not having taken anti-seizure medications within the past 30 days
- •- no provoking factors for seizures (presence of alcohol withdrawal, drug intoxication, acute meningitis or encephalitis, acute head injury or stroke, acute hypoxic/ischemic encephalopathy, or brain tumor)
- •- no presence of active liver disease or serious kidney disease
- •- not pregnant or breast-feeding
- •- not using birth control.
研究者
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