EUCTR2006-002515-27-HU进行中（未招募）不适用
A double-blind, randomised, placebo-controlled, multi-centre study toassess the efficacy and safety of adjunctive zonisamide in paediatric partial onsetseizures - CATZ
Eisai Ltd0 个研究点目标入组 266 人开始时间: 2007年9月14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 generalized seizures according to the International League
- •Against Epilepsy’s Classification of Epileptic Seizures (1981).
- •5. Diagnosis should have 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).
- •NOTE: If using a vagal nerve stimulator (VNS), it must have been implanted for
- •at least five months and stimulator parameters must remain unchanged for at least
- •one month prior to Visit 1 (start of the Screening Period), and throughout the
- •entire study period. VNS will be considered as one AED for the purposes of this
- •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
- •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 preexisting
- •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 >135
- •µmol/l (1.5mg1/dl).
- •10. Subject had a predisposing condition that might interfere with absorption,
- •distribution, or excretion of zonisamide.
- •11. Subject has a history of psychiatric illness.
- •12. Subject has a history of suicide attempt.
- •13. Female subject who is pregnant or lactating.
- •14. Subject has a history of demonstrated non-compliance with treatment or, the
- •subject, parent or legal guardian can be reasonably expected not to be compliant
- •with study procedures or to complete the study.
- •15. Female subject of 10 years or greater or of child bearing potential (i.e. started
- •menses) and is not taking or prepared to take a medically acceptable form of
- •contraception (i.e. oral contraceptive pill, surgical sterilisation, an implant or an
- •injected form of contraception or intrauterine device), or who is not prepared to
- •abstain from sexual activity for the duration of the study and one month after last
- •administration of study medication.
- •NOTE: Should a female subject become of childbearing potential during the study,
- •they must be reconsented, in order to give consent to undergo pregnancy testing
- •and either confirm abstinence or receive medically appropriate form of
- •contraception.
- •16. Subject has clinically significant abnormal laboratory values at the Screening Visit
- •17. Subject has a history of demonstrated non-compliance with treatment or, the
- •subject, parent or legal guardian can be reasonably expected not to be compliant
- •with study procedures or to complete the study.
- •18. Subject has received previous treatment with zonisamide.
- •19. Subject is treated with a ketogenic diet or is likely to have surgery for epilepsy in
- •the trial period.
- •20. Subject requires frequent rescue benzodiazepines (one or more times a month).
- •21. Concomitant use of felbamate or use of felbamate within 2 months prior to Visit 1.
- •22. Subject has elevations of liver enzymes, alanine aminotransferase (ALT), and
- •aspartate aminotransferase (AST) > 2 times the upper limit of normal (ULN).
- •23. Subject has evidence of significant active and unstable haematological disease; i.e.
- •white blood cell (WBC) count < 2500/µL or an absolute neutrophil count <
- •24. Subject with clinically significant active hepatic disease, cardiovascular,
- •metabolic, respiratory, renal, endocrinological, any other clinically significant
- •organic diseases and gastrointestinal diseases within 30 days prior to the
- •Screening Visit.
- 另有 4 项未显示
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