Responsiveness to Dalfampridine Treatment Among Multiple Sclerosis Patients Followed at the Mandell MS Center: Characterizing Clinical Predictors of Response and Identifying Additional Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change in 25ft walk time
研究概览
简要总结
Ampyra (dalfampridine-ER) was approved by the FDA (2010) for improving walking speed in persons with multiple sclerosis. This project seeks to determine if there are other benefits to taking dalfampridine besides an increase in walking speed. This is strictly an observational study and research staff will not be involved in any decisions to stop or start taking the medication.
详细描述
Subjects will be evaluated before starting medication, throughout a 14week period after starting D-ER as well as at 12 and 18months following the start date of medication regardless of if they stayed on medication or not.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
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
- •Confirmed clinical diagnosis of MS by McDonald criteria
- •Prescribed ampyra (dalfampridine) as part of usual care, but have not yet started taking the medication before baseline visit
- •Receive MS care at the Mandell MS center
- •Cognitively able to understand directions and complete protocol (score of 22 or greater on the MMSE)
- •18 years of age or older
排除标准
- •Already began to take drug prior to baseline research visit
- •Not planning to continue care at Mandell Center for at least 14 weeks after initiation of therapy
- •Unwilling or unable to complete assessments
结局指标
主要结局
Change in 25ft walk time
时间窗: Baseline (pre drug) and followup at 3.5 weeks, 7 weeks, 10.5 weeks and 14weeks
Change in 6 minute walk distance
时间窗: Baseline (pre drug) and followup at 3.5 weeks, 7 weeks, 10.5 weeks and 14weeks
Measure of endurance
次要结局
- Change of Upper extremity dexterity with 9hole peg test(Baseline (pre drug) and followup at 3.5 weeks, 7 weeks, 10.5 weeks and 14weeks)
研究者
Jennifer Ruiz, DPT
Research Manager
Mount Sinai Rehabilitation Hospital