EUCTR2012-005021-76-IT进行中（未招募）不适用
A Phase 2A Randomized, Placebo Controlled Trial of EPI-743 in Children with Rett Syndrome
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
- Female
入选标准
- •1.Diagnosis of Rett syndrome Stage 1-2 2.Abnormal disease biomarkers 3.Confirmed MeCP2 mutation 4.Patient or patient’s guardian able to consent and comply with protocol requirements 5.Abstention from use of Coenzyne Q10, vitamin E and Idebenone two weeks prior enrollment of treatment with EPI-743
- •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.Any condition, which in the opinion of the investigator could compromise the subject’s safety or adherence to treatment with EPI-743 2.Clinically significant allergy or hypersensitivity to EPI-743 or to any of the excipients of with EPI-743 (eg., sesame oil) 3.Clinically significant allergy or hypersensitivity to VitaminE 4.Lack of confirmation of MeCP2 mutation 5.Clinical history of bleeding or abnormal baseline PT/PTT 6.Diagnosis of any other concurrent inborn error of metabolism 7.Hepatic insufficiency with LFTs greater than 3 times upper limit of normal 8.Renal insufficiency requiring dialysis 9.End stage cardiac failure 10.Fat malabsorption syndromes precluding drug absorption
研究者
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