DRKS00000179招募中2 期
A randomized, double-blind study versus placebo for the evaluation of the efficacy of doxycycline administered by oral route in patients affected by sporadic Creutzfeldt-Jakob disease - CJK - Zerr
niversitätsmedizin Göttingen,Georg-August-Universität0 个研究点目标入组 28 人开始时间: 2009年8月5日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •1. Age 18 to 80 years
- •2. Diagnosis of probable or definite sporadic CJD according to the WHO criteria
- •3. First symptoms reported no more than 6 months ago
- •4. Brain MRI within 6 months and an EEG within 12 months prior
- •5. No contraindications to the use of Tetracyclines
- •6. Written informed consent by patient or legal representative
- •7. Women of child-bearing age have to use effectiv contraception (oral contraception alone not sufficient, since Doxycyline compromises the absorption of orally administered contraceptives)
排除标准
- •1. Family history of a prion desease
- •2. End-stage liver, heart or renal disease
- •3. Active malignancy
- •4. Female subjects who are pregnant or lactating
- •5. Known intolerance/anaphylaxis to tetracycline
- •6. Receiving an experimental drug or having participated in a clinical trial within 12 weeks prior to screening
- •7. Employees of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study centre
- •8. Living will prohibiting the use of intensive-care or life-prolonging treatment
- •9. Administration of absolutely necessary medication interacting with study medications
研究者
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