Therapeutic Effect of Dalfampridine on Gait Incoordination in Spinocerebellar Ataxias- A Randomized, Double-blinded, Placebo-controlled, Crossover Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Timed 25 Feet Walking Test (T25FW)
研究概览
简要总结
Investigators expect there will be improvement in walking speed and steadiness after taking Dalfampridine, thereby improving activities of daily living and enhancing social and occupational functions for patients with spinocerebellar ataxia.
详细描述
Twenty spinocerebellar ataxia patients will be randomized to receive either Dalfampridine or placebo over a total period of 10 weeks. After entering the study, patients will return every 2 weeks for evaluation. After four weeks, intervention will be stopped and patient will enter a 2-week wash out period where they do not take any drug. Then, patients will be given the opposite treatment (Dalfampridine or placebo) and this "crossover" study will be performed for another 4 weeks. Investigators expect there will be improvement in walking speed and steadiness after taking Dalfampridine, thereby improving activities of daily living and enhancing social and occupational functions.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals at age 18 years or older.
- •Individuals who can provide the informed consent
- •Genetic confirmed definite spinocerebellar ataxias (SCA)
- •Able to complete two trials of the timed 25-foot walk at screening
排除标准
- •Patients who has severe ataxia and unable to ambulate.
- •Any orthopedic condition that would affect motor performance.
- •Patients with secondary ataxia from general medical disorders
- •Individuals who have major psychiatric disorders that prevents compliance
- •History of epilepsy
- •Patients with active drug or alcohol use or dependence that would interfere with adherence to study requirements
- •Inability or unwillingness of subject or legal guardian/representative to give written informed consent.
研究组 & 干预措施
Dalfampridine and then placebo
Participant first receive Dalfampridine at an oral dose of 10mg every 12 hours, for 4 weeks. After a washout period of 2 weeks, they then receive Placebo tablet orally every 12 hours, for a 4 weeks period.
干预措施: Dalfampridine (Drug)
Dalfampridine and then placebo
Participant first receive Dalfampridine at an oral dose of 10mg every 12 hours, for 4 weeks. After a washout period of 2 weeks, they then receive Placebo tablet orally every 12 hours, for a 4 weeks period.
干预措施: Placebo (Drug)
Placebo, Then Dalfampridine
Participant first receive Placebo tablet orally every 12 hours, for a 4 weeks period. After a washout period of 2 weeks, they then receive Dalfampridine at an oral dose of 10mg every 12 hours, for 4 weeks.
干预措施: Dalfampridine (Drug)
Placebo, Then Dalfampridine
Participant first receive Placebo tablet orally every 12 hours, for a 4 weeks period. After a washout period of 2 weeks, they then receive Dalfampridine at an oral dose of 10mg every 12 hours, for 4 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Timed 25 Feet Walking Test (T25FW)
时间窗: Baseline and 4 weeks after Dalfampridine or placebo
The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time, in seconds, is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. Baseline values are recorded twice. One was at the beginning of the intervention. The second was 2 weeks after washout period and before the second intervention.
次要结局
- Biomechanical Assessment of Gait (BAG)-Stride Length(Baseline and 4 weeks after Dalfampridine or placebo)
- Change in Scale of Assessment and Rating of Ataxia (SARA)(Baseline and 4 weeks after Dalfampridine or placebo)