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临床试验/NCT00297323
NCT00297323已完成不适用

An Open Observational Safety Study During Administration of Topamac, as Monotherapy in Epileptic Patients With no Prior Treatment or Unsuccessfully Treated With Other Antiepileptic Drug

Janssen Cilag Pharmaceutica S.A.C.I., Greece0 个研究点目标入组 80 人开始时间: 2005年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
主要终点
The primary outcome is efficacy.

研究概览

简要总结

The purpose of this observational study is to evaluate the safety of topiramate in adults and children with epilepsy (or seizures) who have not received or have not responded to treatment with previous antiepileptic medication.

详细描述

Topiramate is a medication that is approved for the treatment of seizures. In accordance with international guidelines, studies are conducted after a drug is marketed to continue to evaluate and expand the knowledge regarding its safety. This is a multi-center, open-label observational safety study to collect information regarding the dosage, tolerability and effectiveness of topiramate in adults and children with epilepsy (or seizures). Patients who have not received previous treatment for epilepsy or for whom previous treatment was ineffective or intolerable will receive 6 months of treatment with topiramate. Topiramate will be given at low doses initially and gradually increased as needed for each patient to control seizure activity. Safety evaluations (incidence of adverse events and laboratory tests) and assessment of patient health status will be performed throughout the study. Effectiveness will be evaluated by recording the frequency of seizures occurring during the study. Patient and physician satisfaction with topiramate treatment will also be recorded. At the end of the study, the treating physician may continue treatment with topiramate in responding patients as appropriate. The study hypothesis is that topiramate will be effective in achieving and maintaining control of seizure activity and is well-tolerated. Observational study - No investigational drug administered.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
2 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who have not received previous treatment with antiepileptic medications or patients who did not respond to previous treatment with antiepileptic medications, defined as a lack of effectiveness of the medication(s), or the inability to take the medication(s) due to adverse effects

排除标准

  • Patients not suffering from epilepsy, whose seizures are due to other causes including disease, exposure to harmful substances, active infection or tumor and are manageable
  • Patients with a hypersensitivity to topiramate or to some of its components
  • Patients who should not take Topiramate for reasons listed in its approved Summary of Product Characteristics (printed information about a medication that describes its actions, side effects and intended patients)
  • Patients who are uncooperative or for whom obtaining compliance with study visit schedules and procedures and information required by the study would be difficult

研究组 & 干预措施

001

干预措施: Topiramate (Drug)

结局指标

主要结局

The primary outcome is efficacy.

时间窗: Visit 1-5

次要结局

  • Tolerability(Visit: 1-5)
  • Safety of topiramate monotherapy(Visit: 1-5)

研究者

发起方
Janssen Cilag Pharmaceutica S.A.C.I., Greece
申办方类型
Industry

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