EUCTR2007-000198-53-ES进行中（未招募）1 期
Estudio abierto de extensión de un estudio doble ciego, aleatorizado, controlado con placebo y multicéntrico, para evaluar la eficacia y la seguridad de zonisamida como tratamiento adyuvante en crisis epilépticas parciales en pediatría
Eisai Ltd0 个研究点目标入组 144 人开始时间: 2008年12月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 144
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
入选标准
- •1.Subject has completed the double-blind study, E2090-E044-312.
- •2.Parent/caregiver is willing to sign an informed consent where the subject is under the age of consent.
- •3.Subject is male or female aged 6?18 years inclusive, who is willing to give informed (written or verbal) assent, if applicable. If mandated by local regulations, subjects of relevant age will be required to sign an appropriate informed consent.
- •4.Subject is in general good health as determined by medical history, physical exam and screening laboratory results.
- •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 has a body weight < 20 kg.
- •2.Subject has developed a history of renal calculi or renal insufficiency (creatinine level > 135 ?mol/l (1.5 mg/dl).
- •3.Subject has a known diagnosis of human immunodeficiency virus (HIV) or hepatitis B or C.
- •4.Subject has a history of sensitivity to sulfonamide drugs or to zonisamide and its excipients.
- •5.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 sterilisation, an implant or injected form of contraception, or intrauterine device), or who is not prepared to abstain from sexual activity for the duration of the study and for one month after the last administration of study medication.
- •NOTE: Should a female subject become of child bearing potential during the study, they must be re-consented in order to undergo pregnancy testing and either confirm abstinence or receive a medically appropriate form of contraception.
- •6.Subject has a recent history of excessive alcohol use or drug abuse.
- •7.Subject has a history of suicide attempt.
- •8.Subject has a clinically significant organic disease.
- •9.Subject has a history of demonstrated non-compliance with treatment or subject or parent/legal guardian can be reasonably expected not to be compliant with study procedures or to complete the study.
- •10.Frequent need of rescue benzodiazepines (one or more times a month).
- •11.Concomitant use of acetazolamide, carbonic anhydrase inhibitors such as topiramate, furosemide and drugs with anticholinergic activity.
- •12.Concomitant use of felbamate or use of felbamate within 2 months prior to Visit 1 of the E2090-E044-312 study.
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