NCT01800097终止3 期
Treatment of Post Stroke Fatigue With Modafinil, Effect on Rehabilitation, Fatigue and Bonemass Index
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Multidimensional Fatigue Inventory (MFI- 20)
研究概览
简要总结
This study is an investigator initiated placebo controlled double blinded trial. The hypothesis is that treatment with modafinil positively will affect behavioural and cognitive rehabilitation after stroke, causing the treatment group to experience decreased fatigue, increased endurance, improved skills of sustaining attention and faster reaction times. The cognitive rehabilitation will show in increased muscle mass, decreased osteoporosis and better physical performances due to a higher level of physical activity.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •18 years of age and stroke within 14 days
- •Modified Rankin Scale 3 or under and Barthel 85 or over before stroke
- •Person that can understand instruction and do tests and questionnaires on their own or with support
- •has given informed consent
- •MFI-20 score of 12 or more
- •Infertile person or fertile women tested negative of pregnancy and using safe anticonception
排除标准
- •Dementia or other neuropsychiatric disease making the person incapable of understanding instructions
- •Other disease with fatigue as a known symptom
- •stroke induced by trauma, infection or surgical procedure
- •former drug abuse
- •known contraindication to treatment with modafinil
- •known active malignancy, benign intracranial tumor, subdural or epidural bleeding
- •kidneydysfunction with creatinin more than 265 micromol/L or liver disease with ASAT (aspartate aminotransferase) elevated to more than 70 U/L for women or 100 U/L for men.
- •allergy to project treatment
- •use of benzodiazepin or antiepileptic drugs in a fixed dose. Sleeping pills not included.
- •Patients threaded with ciclosporin or anti HIV medication
研究组 & 干预措施
placebo
Placebo Comparator
placebo
干预措施: placebo (Drug)
Modafinil
Active Comparator
Modafinil
干预措施: modafinil (Drug)
结局指标
主要结局
Multidimensional Fatigue Inventory (MFI- 20)
时间窗: 3 months
Questionnaire
次要结局
- MFI-20(6 months)
- Fatigue severity scale (FSS)(3 months)
- FSS(6 months)
研究者
Karsten Overgaard
Principal Investigator
Herlev Hospital
研究点 (1)
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