EUCTR2005-000260-57-DE进行中（未招募）不适用
Randomized trial to assess efficacy and safety of an add-on treatment with zonisamide in adults with focal epileptic seizures with or without secondary generalization
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Eisai GmbH
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
- •oAdult aged between 18 years and 74 years
- •oFocal epileptic seizures with or without secondary generalization
- •oPresent treatment with one or two antiepileptic drugs (constant dosage during the 8 weeks baseline phase prior to initiation of treatment with zonisamide). Stimulation of the vagus nerve is permitted and will not be counted as antiepileptic drug.
- •oAt least 6 focal or clonicotonic seizures documented completely in a seizure diary or the patient chart during the 8 weeks prospective or retrospective baseline phase
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •oEpileptic state during the past year
- •oNon-epileptic fits
- •oGeneralized epilepsy
- •oConcomitant progressive CNS disease including progressive myoclonus epilepsy
- •oConcomitant treatment with vigabatrine and/or topiramate
- •oHepatic and/or renal insufficiency (creatinine > 2 mg% or GPT > 2 times ULN)
- •oBody weight less than 40 kg
- •o(History of) kidney stones; erythrocyturia; family history (in parents, children, brothers and sisters or grandparents) of kidney stones
- •o(History of) drug and/or alcohol dependence
- •oActive psychosis
- •oSuicide attempt during the past 3 years
- •oPre-treatment with zonisamide
- •oKnown hypersensitivity to sulfonamides
- •oConcomitant treatment with neuroleptic drugs
- •oMore than 4 consecutive weeks of freedom from seizure during baseline phase
研究者
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