EUCTR2015-005460-42-ES进行中（未招募）1 期
Phase III clinical trial, double-blind, cross-way, to evaluate the safety and efficacy ascorbic acid (vitamin C) and tocopherol (vitamin E) combination versus placebo for the treatment of cognitive and behavioral disorders in children with fragile x syndrome
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud0 个研究点开始时间: 2016年4月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- Male
入选标准
- •1. Diagnosis of Fragile X syndrome by genetic testing of molecular biology, with full mutation result methylation.
- •2. Patients older than 2 years and under 9 years.
- •3. Signed the informed consent document before starting their participation in the trial.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 30
- •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 advanced, severe or unstable disease.
- •2. Individuals with other psychiatric diagnosed as the first diagnosis.
- •3. Suffer serious medical problems in the last 12 months.
- •4. Previous treatment with 100 mg of vitamin E or C a day in the last month.
- •5. Any physical, mental or sensory impairments that prevent the assessment of effectiveness.
- •6. Hypersensitivity to any component of the preparation.
- •7. Liver failure or severe renal or previous history of kidney stones.
- •8. Any treatment regimen, including treatment with psychotropic drugs and / or anticonvulsant therapy that has not been stable for a period ? 4 weeks prior to randomization.
- •9. Current treatment with more than two psychoactive drugs, excluding medication used specifically for seizure control.
- •10. Hypoprothrombinemia secondary to vitamin K deficiency.
- •11. Sensitivity to any of the compounds of formula treatment.
- •12. Deficiency of G-6-PD.
- •13. Use of oral anticoagulants.
- •14. Suspicion of change the pharmacological or non-pharmacological interventions during the course of the study.
研究者
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