CTRI/2010/091/000158已完成3 期
A double-blind, randomised, placebo-controlled, multi-centre study to assess the efficacy and safety of adjunctive Zonisamide in paediatric partial onset seizures
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 204
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Inclusion Criteria:
- •1.Subject is male or female aged 6-17 years inclusive.
- •2.Parent or 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 Classification of Epileptic Seizures (1981).
- •5.Diagnosis has been established by clinical history, electroencephalogram (EEG) and computed tomography or magnetic resonance imaging (CT or MRI) of the brain consistent with localization related epilepsy.
- •6.Subject has more than four (simple or complex) partial seizures (with or without secondary generalization) 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 study.
- •8.Subject is in general good health as determined by medical history, physical exam and screening laboratory results.
- •9.Parent or guardian is willing and able to complete a seizure diary for the duration of the study.
排除标准
- •Exclusion Criteria:
- •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 generalized 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 generalized) 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 (1.5 mg1/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 of age 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 sterilization, 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 received previous treatment with zonisamide.
- •18.Subject is treated with a ketogenic diet or is likely to have surgery for epilepsy in the trial period.
- •19.Subject requires frequent rescue benzodiazepines (one or more times a month).
- •20.Concomitant use of felbamate or use of felbamate within 2 months prior to Visit 1.
- •21.Subject has elevations of liver enzymes, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) > 2 times the upper limit of normal (ULN).
- •22.Subject has evidence of significant active and unstable haematological disease; i.e., white blood cell (WBC) count < 2500/µL or an absolute neutrophil count < 1000/µL
- •23.Subject with clinically significant active hepatic disease, cardiovascular, metabolic, respiratory, renal, endocrinological and gastrointestinal diseases or any other clinically significant organic disease, within 30 days prior to the Screening Visit.
- •24.Subjects with known or suspected history of alcoholism or drug abuse within the previous two years, or a positive finding on urinary drug screening of any drugs other than prescribed medications.
- •25.Subjects with any other condition that would make them, in the opinion of the Investigator unsuitable for this study.
- •26.Subjects who have participated in a clinical trial involving
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