A Randomized Trial to Evaluate Ampyra for Gait Impairment in Parkinson's Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change in Velocity
研究概览
简要总结
The purpose of this study is to evaluate the effect of AMPYRA on a number of symptoms in Parkinson's disease. AMPYRA is a medication approved by FDA for gait dysfunction in multiple sclerosis. There are multiple studies to suggest that persons with multiple sclerosis benefit from this medication and have major improvements in gait after taking this medication. However, this medication was never studied in Parkinson's disease. This study aims to learn about possible benefits of AMPYRA in Parkinson's disease (PD).
详细描述
Subjects with Parkinson's disease will be randomly assigned to two groups. One group will receive Ampyra first for 4 weeks, followed by 2 weeks break and than 4 weeks placebo while the second group will first receive placebo and then Ampyra.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic PD with stage Hoehn and Yahr Stage>2-3 and with gait freezing or postural instability.
- •On stable dosage dopamine agonist/levodopa, and expected to remain on the same dosage of treatment for the duration of study
- •Age less than 80, onset of disease at age more than
- •Able to give consent
排除标准
- •Past medical history of seizures,
- •History of renal insufficiency,
- •History of cardiac arrhythmia,
- •Severe arthritis,
- •Women of childbearing potential,
- •Cognitive impairment
- •Age more than
- •PD patients stage 4 H&Y
- •PD patient with recent introduction of dopamine agonist or IMAO B
- •PD patients participating in other studies
研究组 & 干预措施
Ampyra
Ampyra 10 mg po BID for 4 weeks followed by placebo 4 weeks
干预措施: Ampyra first, then Placebo (Drug)
Placebo
placebo 4 weeks followed by Ampyra 10 mg po BID
干预措施: placebo first, then Ampyra (Drug)
结局指标
主要结局
Change in Velocity
时间窗: baseline and 4 weeks
The primary outcome measure will be the change in gait velocity as measured with by 3-dimensional gait analysis system.
次要结局
- Timed Up and Go (TUG) Score(4 weeks)
- Freezing of Gait Questionnaire (FOGQ)(4 weeks)
- United Parkinson's Disease Rating Scale Score(UPDRS) ,(4 weeks)
- Timed 25-foot Walk Test (T25FW)(4 weeks)
- Change in Stride Legth(4 weeks)
研究者
Corneliu C Luca
Neurology Instructor
University of Miami