Fampyra Outcome Measures Study: a Study of Different Outcome Measures on the Effect of Fampyra
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 4
- 主要终点
- The mean change in SSST
研究概览
简要总结
Fampridine-SR is registered for the treatment of walking incapacity in MS patients. Two pivotal trials show that app. 40% of MS patients with walking incapacity can improve walking speed averagely 25% when recieving the drug. This has been shown using the Timed 25 Foot Walk Test (T25FW). No effect on cognition and upper limb function has been shown, but this has not been investigated in patients responding to the drug measured by the abovementioned test.
The question is if this will be the case and also if another walking test, termed the Six Spot Step Test (SSST), will be more sensitive to the effect of Fampridine-SR.
Primary outcome measure is the effect measured by SSST. The hypothesis is that SSST is not less sensitive to the effect of Fampridine-SR than T25FW.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with clinically definite multiple sclerosis diagnosed according to the McDonald criteria
- •Pyramidal FS >= 2
排除标准
- •History of epileptic seizures
- •MS relapse or change in disease modifying treatment (DMT) within 60 days
- •cancer within five years
- •uncontrolled hypertension
- •clinically important cardiac, hepatic, renal or pulmonary disease
- •pregnancy
- •breast feeding
- •concomitant treatment with cimetidine, carvedilol, propranolol and metformin
研究组 & 干预措施
Fampridine-SR
Initially all participants receive Fampridine-SR 10 mg BID in an open label enrichment phase lasting four weeks. Those 40% responding the most by SSST will go onto phase two. 50% of these will receive 10 mg Fampridine-SR BID for four weeks.
干预措施: Fampridine-SR (Drug)
Placebo
In the intervention phase 50% will receive placebo BID
干预措施: Fampridine-SR (Drug)
结局指标
主要结局
The mean change in SSST
时间窗: SSST is measured before and at the end of four weeks of treatment
SSST is measured before treatment with Fampridine-SR. Then again measured at day 26, 27 or 28 of four weeks of treatment with Fampridine-SR.
次要结局
- Mean change in T25FW(Four weeks)
- Mean change on Chair Rise Test(Four weeks)
- Mean change on 9-Hole Peg Test (9HPT)(Four weeks)
- Mean change on Symbol Digit Modalitites Test (SDMT)(Four weeks)
- Mean change in hip flexion, knee flexion and knee extension force(Four weeks)
研究者
Henrik Boye Jensen
MD, PhD Fellow
University of Southern Denmark