Randomized, Placebo-controlled, Double-blind Pilot Trial to Evaluate the Safety and Efficacy of Ropinirole in Motor Recovery After Stroke
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to assess efficacy, as well as safety, of Ropinirole in improving movement among patients with chronic stroke.
详细描述
Stroke is a leading cause of disability. Current treatments target injury and must be delivered within hours. A body of literature suggests that there are processes ongoing days-months after stroke that can be targeted therapeutically, and improve function. The current study evaluates one such potential therapy, the dopamine agonist ropinirole. The current study tests the hypothesis that patients with chronic stroke randomized to ropinirole+physiotherapy will show improved gait velocity over the 12 weeks of study participation as compared to patients randomized to placebo+physiotherapy. A secondary aim is to test the hypothesis that ropinirole will improve three secondary endpoints at 12 weeks after study entry: the proportion of patients with no significant disability (Barthel Index ≥ 95); overall motor status, measured with the arm/leg FM score; and overall physical function, defined as the score on the Stroke Impact Scale-16 (SIS-16). This study will also evaluate the safety of ropinirole in patients recovering from stroke.
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
- •Stroke onset 4 weeks-12 months prior
- •Stroke is radiologically confirmed as either (a) ischemic or (b) hemorrhagic
- •Minimum age 18
- •No significant pre-stroke disability
- •No other stroke in previous 3 months
- •Absence of major depression
- •Fugl-Meyer (FM) motor score of 23-83 out of 100
- •Functional Independence Measure (FIM) ambulation-subscore of 3 or more, and 50 foot walk takes longer than 15 seconds
排除标准
- •Significant daytime somnolence or any substantial decrease in alertness, language reception, or attention
- •Pregnant or lactating
- •Advanced liver, kidney, cardiac, or pulmonary disease
- •Orthostatic hypotension
- •Current use of ciprofloxacin, a centrally acting dopamine agonist, or a centrally active dopamine antagonist
- •A terminal medical diagnosis consistent with survival < 1 year
- •Coexistent major neurological disease
- •Coexistent major psychiatric disease
- •A history of significant alcohol or drug abuse in the prior 3 years
- •A coexistent disease characterized by an abnormality of CNS dopaminergic tone
- •Current enrollment in another investigational study related to stroke or stroke recovery
- •Contraindication to ropinirole prescription
结局指标
主要结局
未指定
次要结局
- Barthel Index(Measured at weeks 1, 9, and 12)
- Leg motor Fugl-Meyer scale(Measured at baseline and weeks 1, 2, 4, 6, 7, 8, 9, and 12)
- Stroke Impact Scale-16(Measured at weeks 1, 4, 7, 9, and 12)
- Gait endurance(Measured at weeks 1, 2, 4, 6, 7, 8, 9, and 12)
- Hamilton Depression Scale(Measured at baseline and weeks 1, 2, 9, and 12)
- Safety(12 weeks)
研究者
Steven C. Cramer, MD
Professor
University of California, Irvine