EUCTR2006-002515-27-IT进行中（未招募）不适用
A double-blind, randomised, placebo-controlled, multi-centre study to assess the efficacy and safety of adjunctive zonisamide in paediatric partial onset seizures - ND
EISAI LTD UK0 个研究点目标入组 266 人开始时间: 2008年3月12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
- 266
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
- •1. Subject is male or female aged 6?17 years inclusive. 2. Parent/guardian is willing to sign an approved informed consent form, and accompany the subject on all study visits. 3. Subject is willing to give informed (written or verbal) assent and if appropriate written informed consent. 4. Subject has a clinical diagnosis of epilepsy with partial-onset seizures with or without secondary generalised seizures according to the International League Against Epilepsy?s Classification of Epileptic Seizures (1981). 5. Diagnosis has been established by clinical history, electroencephalogram (EEG) and computed tomography/ magnetic resonance imaging (CT/MRI) of the brain consistent with localisation related epilepsy. 6. Subject has > four (simple or complex) partial seizures (with or without secondary generalisation) per month over the eight week Screening Period with at least one seizure in each four week period and with no 21 day period being seizure free. 7. Subject is taking a stable regimen of one or two other AEDs for at least one month prior to Visit 1 (start of the Screening Period). 8. Subject is in general good health as determined by medical history, physical exam and screening laboratory results. 9. Parent/guardian is willing and able to complete a seizure diary for the duration of the study
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subject of body weight < 20 kg at the Screening Visit. 2. Subject is unable to swallow capsules. 3. Subject has progressive neurological disease (determined by diagnosis or a pre-existing brain image such as a CT scan or MRI). 4. Subject has a history of idiopathic generalised epilepsy as defined by the International League Against Epilepsy (ILAE). 5. Subjects with Lennox-Gastaut syndrome, absence, myoclonic, clonic and/or tonic (other than secondary generalised) and atonic seizures. 6. Subject has psychogenic seizures 7. Subject has a history of status epilepticus within a year of the Screening Visit whilst taking AEDs. 8. Subject has seizures that only occur in clustered patterns, or has seizures that are too close together to count accurately. 9. Subject has a history of renal calculi or renal insufficiency (creatinine levels >194 µmol/l (1.5mg1/dl). 10. Subject had a predisposing condition that might interfere with absorption, distribution, or excretion of zonisamide. See Protocol for other exclusion criteria
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