EUCTR2015-001223-23-Outside-EU/EEA进行中（未招募）不适用
TOPAMAX (Topiramate) Initiated as Monotherapy in Epilepsy (TIME): A Multicenter, Outpatient, Open-Label, Study to Evaluate the Dosing, Effectiveness and Safety of TOPAMAX as Monotherapy in the Treatment of Epilepsy in Clinical Practice
Johnson & Johnson Pharmaceutical Research and Development, L.L.C.0 个研究点目标入组 409 人开始时间: 2015年4月24日最近更新:
适应症
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
- 409
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
- •- Patients having new-onset epilepsy or epilepsy relapse characterized by partial-onset seizures or primary generalized tonic-clonic seizures
- •- having at least 1 seizure within the 3 months prior to entry
- •- who are previously untreated for epilepsy, previously treated for epilepsy, or if currently taking epilepsy medication, must have been taking it for less than 6 weeks
- •- weighing at least 25 kilograms (approximately 55 pounds)
- •- if female of childbearing potential, must be using an acceptable method of birth control
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 409
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 409
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 409
排除标准
- •- Patients who have previously taken topiramate for the treatment of epilepsy
- •- who are currently taking topiramate for any reason
- •- having active liver disease
- •- having a clinically significant medical condition or disease
- •- women who are pregnant or breastfeeding
研究者
相似试验
已完成
3 期
A Study of the Efficacy and Safety of Topiramate Treatment in Patients With EpilepsySeizuresEpilepsyNCT00266591Johnson & Johnson Pharmaceutical Research & Development, L.L.C.51
已完成
3 期
A Study of the Effectiveness and Safety of Topiramate Compared With a Standard Therapy in Patients Newly Diagnosed With EpilepsySeizuresEpilepsyNCT00236717Johnson & Johnson Pharmaceutical Research & Development, L.L.C.865
已完成
2 期
Efficacy of topiramate and topiramate with omega-3 fatty acid in prophylaxis of children migraine headachesmigraine headache.MigraineIRCT20091027002639N23Yazd University of Medical Sciences60
已完成
2 期
Efficacy of topiramate alone and topiramate with supplement vitamin D3 on migraine headaches in 5-15 year old migraineur childreMigraine.MigraineIRCT201701092639N20Shahid Sadoughi University of Medical Sciences, Yazd, Iran60
已完成
4 期
A Study to Evaluate the Dosing, Effectiveness and Safety of Topiramate for the Treatment of EpilepsySeizuresEpilepsies, PartialEpilepsy, GeneralizedSeizures, Tonic-ClonicEpilepsyNCT00266604Johnson & Johnson Pharmaceutical Research & Development, L.L.C.409