EUCTR2006-000788-27-DE进行中（未招募）1 期
International Collaborative Infantile Spasms Study (ICISS) - ICISS
Royal United Hospital Bath NHS Trust0 个研究点目标入组 410 人开始时间: 2010年6月11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
- 410
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
- •The clinical features of Infantile Spasms confirmed by the consultant in charge or his/her nominated deputy.
- •An EEG that is hypsarrhythmic or similar, compatible with the diagnosis of Infantile Spasms.
- •Signed informed consent has been given.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 410
- •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
- •More than 72 hours has elapsed since the EEG was performed.
- •More than 72 hours has elapsed since the clinical features were confirmed.
- •Age less than two months or greater than one year and two months.
- •A diagnosis or high risk of tuberous sclerosis (known affected parent, previously diagnosed cardiac rhabdomyoma, hypomelanic macules, forehead fibrous plaque, shagreen patch, retinal phakoma or known polycystic kidneys).
- •Previous treatment for infantile spasms other than a therapeutic trial of pyridoxine to exclude pyridoxine dependent seizures. Note - previous treatment for other seizure types is not a reason for exclusion.
- •Previous treatment (within the last 28 days) with vigabatrin or hormonal treatments.
- •A contraindication to vigabatrin or hormonal treatments. A risk of a visual field defect is not considered a contraindication.
- •A lethal or potentially lethal condition, other than infantile spasms, with a risk of death before 18 months of age.
- •Doubt about the ability of the parents or guardians to know when the spasms stop.This is likely to include parents known to be intravenous drug abusers.
- •Unavailable for follow up to 18 months of age.
- •Those enrolled in a concurrent trial that is still in the active phase.
- •The language ability of the parents or guardians is such that they may not understand what is being requested of them.
- •The language ability of the parents or guardians is such that it will not be possible to undertake the Vineland assessment.
研究者
相似试验
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International Collaborative Infantile Spasms Study (ICISS) - ICISSInfantile spasms are a rare severe form of epilepsy affecting approx 1 in 2,250 infants, usually under the age of 1 year. Affected infants have a very abnormal EEG and a poor prognosis for subsequent epilepsy and neuro-development. There is a high risk of underlying neurological disease that independently causes delayed development and other seizure disorders. There is a high risk of a poor outcome even when there is no other detectable underlying neurological disorder.EUCTR2006-000788-27-GBRoyal United Hospital Bath NHS Trust410
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