EUCTR2011-000990-29-ES进行中（未招募）不适用
Multinational European Trial for Children with theOpsoclonus Myoclonus Syndrome / Dancing Eye SyndromeOMS/DES - OMS/DES 2011
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •?Children with newly diagnosed OMS/DES either NB-pos or NB-neg.
- •Three out of the following four components are necessary for the diagnosis of OMS/DES:
- •-Opsoclonus or ocular flutter (but not nystagmus)
- •-Ataxia and/or myoclonus
- •-Behavioural change and/or sleep disturbance
- •-Neuroblastoma
- •?Age 6 months or over up to less than 8 years (< 8th birthday)
- •?Treatment start with the standard corticosteroid treatment with dexamethasone pulses as proposed by the guidelines given in this trial protocol
- •?In patients with presumed NB-neg OMS/DES, neuroblastoma must be excluded according the guidelines of this trial
- •?Documented informed consent for treatment and enrolment in the trial by parents / legal representatives .
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •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
- •?Patients with opsoclonus, myoclonus or ataxia caused by other identified disease (e.g. current active CNS infection, neurometabolic disorder or demyelination).
- •An identified viral precursor is not an exclusion criterion.
- •?prior or parallel use of chemotherapy (other than required for treatment of the neuroblastoma)
- •?Corticoid steroid for OMS/DES or other reasons lasting 14 days or more immediately before treatment start according the standard treatment proposed (treatment with corticosteroids for less than 14 days will be allowed)
- •?contre-indication of use of one of the experimental study drug (cf Summary of Product Characteristics used in this study)
研究者
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