Effect of Dalfampridine on Gait Impairment, Cognition and Fatigue in Egyptian Patients With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- gait
研究概览
简要总结
The only approved treatment for impaired ambulation in MS is Dalfampridine (also known as fampridine, 4-aminopyridine, 4-AP). Fampridine penetrates the blood-brain barrier and improves impaired axonal conduction by selectively blocking potassium channels. Moreover, further studies investigated the possible beneficial effect of dalfampridine on cognitive functions and fatigue.
The main objective of this study is to investigate the effect of dalfampridine on gait impairment, cognitive functions and fatigue in a sample of Egyptian patients with multiple sclerosis.
详细描述
Type of the Study: randomized double blinded placebo controlled study. Study Setting: MS outpatient clinic in Ain Shams University hospital and Dar Alshefa Hospital, they are located in Eastern Cairo and serves large sector of the ministry of health patients in Greater Cairo.
Period two years. Population patients with relapsing remittent multiple sclerosis attending to ms clinic meeting the inclusion criteria.
Sample size: 100 patients (50 patients in active group and 50 patients in placebo group).
Study Procedures:
Patients diagnosed with MS will be evaluated for inclusion and exclusion criteria using the selected screening scales. Eligible patients will be randomly assigned to one of two groups: dalfampridine ER 10mg twice daily group and placebo group for 12 consecutive weeks.
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)
盲法说明
randomization was done by a research randomization, The copy of the randomization table of patients to the 2 groups was kept with 2 different personnel not working on the study.
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
- •Age > 18 years.
- •Individuals diagnosed with RRMS based on revised McDonald Criteria 2017
- •Patients with Expanded Disability Status Scale (EDSS) ≤ 5.5
- •Patients with gait impairment according to 25 foot walk test (25FWT) with cutoff ≥ 4 seconds
排除标准
- •Women who are pregnant, intended to be pregnant or breastfeeding.
- •Past History of epilepsy or trigeminal neuralgia.
- •History of any psychiatric or medical illness affecting cognition and fatigue.
- •Other comorbidities that might affect gait.
- •Clinical relapse in the last three months.
- •Uncooperative patients or couldn't perform the required scales.
- •Patients with moderate to severe depression according to patient health questionnaire (PHQ-9) with cutoff point ≥15.
研究组 & 干预措施
dalfampridine
patients received dalfampridine ER 10mg twice daily
干预措施: Dalfampridine ER, 10 Mg Oral Tablet, Extended Release (Drug)
Placebo
patients received placebo
干预措施: Placebo (Drug)
结局指标
主要结局
gait
时间窗: 3 months
Hauser ambulatory index, higher scores mean a worse outcome
Balance
时间窗: 3 months
Berg balance scale, higher scores mean a worse outcome
次要结局
- cognition(3 months)
- fatigue(3 months)
- Cognition(3 months)
研究者
Ali Shalash
professor
Ain Shams University