CTRI/2008/091/000229未知2/3 期
A Randomized, Double-Blind, Placebo-Controlled Study of Donepezil on Cognitive Function and Behaviour in Children with Fragile X Syndrome
Dr Jitendra Kumar Sahu1 个研究点 分布在 1 个国家目标入组 0 人开始时间: 待定
试验速览
- 阶段
- 2/3 期
- 发起方
- 试验地点
- 1
- 主要终点
- Intelligence Quotient by Kulshreshta adaptation of the Stanford - Binet Test
研究概览
简要总结
The study is a randomized, double blind, parallel group trial evaluating effect of Donepezil on cognitive function and behavior over 12 weeks period. The primary outcome measure will be change in Stanford-Binet intelligence scale from baseline to 12 weeks.
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
入选标准
- •1.Confirmed genetic diagnosis of fragile X syndrome by PCR & Southern blot;
- •Age 6-15 yrs; 3.Regardless of their IQ level if they were able to complete the required neuropsychological testing.
排除标准
- •1.Children below 6 years and beyond 15 years of age;
- •Currently taking any anticholinergic medications or known hypersensitivity to anticholinergic drugs;3.Seizure disorder requiring the use of anticonvulsant medications;4.Clinically significant uncontrolled cardiovascular, renal, hepatic, pulmonary, gastrointestinal, endocrine, metabolic or hematologic conditions.
结局指标
主要结局
Intelligence Quotient by Kulshreshta adaptation of the Stanford - Binet Test
时间窗: Baseline & 12 week
次要结局
- Childhood Autism Rating Scale(Baseline, 12 Week)
研究者
研究点 (1)
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