EUCTR2004-002783-24-GB进行中（未招募）不适用
Prednisolone versus Dexamethasone in Chronic inflammatory demyelinating polyradiculoneuropathy Trial; PREDICT-trial - PREDICT trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 52
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
- •Eligible patients have to have signs and symptoms consistent with CIDP according to the diagnostic criteria as defined by a Dutch Consensus group in 1997. These criteria are derived from the much used and cited criteria of the ad hoc subcommittee of the American Academy of Neurology AIDS Task Force 1991 but contain a few practical modifications. Only definite or probable CIDP patients will be included.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Abnormal erythrocyte sedimentation rate, hemoglobuline, white cell count, immuno-electrophoresis or immunofixation (with the exception of a IgG MGUS), TSH, Vitamin B1/B12, gamma-GT, or glucose
- •2. Pleocytosis in cerebrospinal fluid (CSF) of more than 90/3 (30/mm3)
- •3. Received treatment for CIDP before
- •4. Use of drugs which are known to cause neuropathy
- •5. Age under 18 years
- •6. Contraindication for corticosteroid treatment
- •7. Pregnancy or active wish to become pregnant
- •8. Diseases known to cause neuropathy or to reduce mobility
- •9. Diseases known to lead to severe handicap or death at short notice
- •10. Patients with a subacute inflammatory demyelinating polyneuropathy (SIDP); this is a subset of patients with spontaneous recovery within 3 months and a monophasic course
- •11. Pure motor CIDP: no sensory signs or symptoms and no abnormalities in sensory nerve conduction studies (SNAP, SNCV, SDLT)
- •12. Refusal to give informed consent or withdrawal of previously given permission
研究者
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