NCT00276341已完成3 期
Efficacy of EGb 761® 120mg Twice a Day Versus Placebo on Cognitive Impairment in Patients With Multiple Sclerosis. A Randomised, Double-blind, Multicentre, Parallel Groups Placebo Controlled Phase III Study.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 47
- 试验地点
- 59
- 主要终点
- Evolution of Paced Auditory Serial Addition Test 3 and 2 seconds between baseline and week 24
研究概览
简要总结
The purpose of this study is to determine whether the use of EGb 761 by patients with Relapsing-Remitting Multiple Sclerosis is effective in improving cognition, when compared to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with Multiple Sclerosis Relapsing-Remitting form
- •Patient with cognitive impairment (as spontaneous complaint by either patient or family)
- •Patient treated with interferon and maintaining same dosage for previous 6 months
- •Patient without major disability (Kurtzke Extended Disability Status Scale ≤6)
排除标准
- •Clinical Multiple Sclerosis relapse within 3 months prior to participation
- •Major psychiatric disease according to Diagnostic and Statistical Manual of Mental Disorders, 4th Ed.
- •Other concomitant disorders possibly jeopardizing the cognitive status evaluation or the follow up of the patient (severe impairment of visual or motor function which may prevent participation in neuropsychological testing)
结局指标
主要结局
Evolution of Paced Auditory Serial Addition Test 3 and 2 seconds between baseline and week 24
次要结局
- 10/36 Visual-Spatial Recall Test
- Symbol Digit Modalities Test
- Trail Making Test A and B
- Beck Depression Inventory Scale
- Evolution of the following tests between baseline and week 24:
- Multiple Sclerosis Functional Composite Test
- Selective Reminding Test
- Verbal Fluency Test
- Empan Test
- Evolution of the following scales between baseline and week 24:
- Cognitive Deficit Interview based screen
- Anxiety Brief Scale
- Modified Fatigue Impact Scale
- Evolution of Quality of Life
- Evolution of the following between baseline, week 12, and week 24: Kurtzke Extended Disability Status Scale, and Clinician Interview Based Impression of Change
研究者
研究点 (59)
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