EUCTR2020-004511-27-BE进行中（未招募）1 期
Add-on clioquinol in drug-resistant childhood epilepsy: an exploratory study - CLIOKID: clioquinol for Drug Resistant Epilepsy in Kids
niversity Hospital Leuven0 个研究点目标入组 20 人开始时间: 2021年1月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
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.Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- •2.In females with child bearing potential: negative pregnancy test or use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some intra-uterine devices, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomized partner
- •3.Age = 4 years and < 18 years at time of inclusion
- •4.Weight = 20 kg at time of inclusion
- •5.Well defined epilepsy history with convulsive seizures (with observable and countable motor component)
- •6.Drug-resistant epilepsy: before inclusion failure of at least 2 AEDs
- •7.Drug-resistant epilepsy: = 4 seizures in the 2 week prospective period (baseline) before visit 2, not all (4) seizures observed in 1 of the 2 weeks. Baseline period can be extended with 1 or 2 weeks.
- •8.The patient is at the moment of inclusion on max 3 anti-epileptic drugs (VNS and ketogenic diet not included)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •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.Participant has a history of liver or kidney disease. Children with a co-existing active neuropathy (such as neuritis optica, transverse myelitis)
- •2.Asian etnicity
- •3. Abnormal low blood level of vitamin B12 or Zn
- •4.Patients with hypothyroidism
- •5.Any disorder, which in the Investigator’s opinion might jeopardize the participant’s safety or compliance with the protocol
- •6.Any prior or concomitant treatment(s) that might jeopardize the participant’s safety or that would compromise the integrity of the Trial
- •7.Exposure to clioquinol before the trial
- •8.Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive
- •9.Participation in an interventional Trial with an IMP or device
研究者
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