NCT00572767终止4 期
Evaluation of the Therapeutic Effect of Amphetamine in Association to Physiotherapy on Motor Recovery After Stroke: a Randomised, Double-Blinded, Placebo-Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Chedoke-McMaster Stroke Assessment (motor impairment measure)
研究概览
简要总结
The aim of the study is to evaluate the effect of Dextro-amphetamin added to physiotherapy on motor recovery in patients after stroke. The study is a double-blinded placebo-controlled randomised controlled trial.
Patients after a first-ever ischemic stroke will receive Dexamphetamine (10mg) twice per week for a duration of five weeks after a baseline phase of two weeks.
The outcome measure focuses on motor recovery and will be assessed:
- one and two weeks before study intervention (baseline phase)
- five times during the study intervention
- one week after study intervention (follow-up)
- once after six and twelve months after start of the study intervention (follow-up).
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
- •patients after first-ever ischemic stroke with a clinical relevant paresis of the upper and lower limb (general clinical muscle testing below level four)
- •correlation of clinical symptoms with a brain imaging (CT or MRI)
- •able to communicate with the neurological examiner and understand the aim/matter of the study (with or without aphasia)
- •start of the first oral application of the study drug between the fourteenth and 60th day after stroke onset
- •older than 13 years
- •given written informed consent (or two independent witnesses)
排除标准
- •intracranial or (chronic) subdural hemorrhages
- •any additional neurological or psychiatric illnesses
- •instable arrythmia
- •not controlled or treated arterial hypertension
- •ensured cardioembolic event
- •anxiolytica, neuroleptica, or alpha-adrenergic antagonists or agonists respectively
- •certain anticonvulsiva or antihypertonica
- •manifest hyperthyreosis
- •dementia or terminal illnesses
- •epilepsy, phaeochromocytoma or glaucoma
- •women known to be pregnant or lactating
研究组 & 干预措施
1
Experimental
干预措施: Dextro-Amphetamin (Drug)
2
Placebo Comparator
干预措施: Glucose (Other)
结局指标
主要结局
Chedoke-McMaster Stroke Assessment (motor impairment measure)
时间窗: Over the whole duration of the study (2001 to 2006, ten times for each patient)
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Motor Recovery in Recent Stroke Patients Treated With Amphetamine and Physical TherapyCerebrovascular AccidentParalysisNCT00001783National Institute of Neurological Disorders and Stroke (NINDS)34
已完成
2 期
A Pilot Trial of Dextroamphetamine for Methamphetamine DependenceMethamphetamine AddictionNCT00630682California Pacific Medical Center Research Institute60
已完成
1 期
Effect of D-amphetamine on Reward FunctioningAnhedoniaNCT03369015The University of Texas Health Science Center, Houston68
已完成
1 期
Clinical Efficacy of Atomoxetine for Methamphetamine DependenceMethamphetamine DependenceNCT01557569University of Arkansas20
进行中（未招募）
2 期
Dimethyl Fumarate in AdrenomyeloneuropathyAdrenomyeloneuropathy Without Cerebral InvolvementNCT06513533Pujol, Aurora, M.D.40