A Randomized Controlled Double-blind Cross-over Trial of Dalfampridine ER for Effect on Ambulatory Activity in People With Multiple Sclerosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Peak Activity Index
研究概览
简要总结
A randomized placebo controlled double-blind cross-over trial of Dalfampridine ER for effect on ambulatory activity in people with multiple sclerosis
详细描述
This is a parallel-group, double-blind, randomized controlled crossover trial with a 1:1 randomization. There are two treatment periods of 4 weeks and a two-week off treatment washout period. Treatment periods are DER (dalfampridine ER) followed by placebo (group A) and placebo followed by DER (group B), respectively. All dosages will be administered twice a week. Purpose of the study is to see if using the study drug(dalfampridine Er) for a short period of time will improve the way subjects with multiple sclerosis (MS) walk.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of MS made at least 3 months prior to based McDonald or Proser criteria.
- •Age 18-75 years old inclusive.
- •Expanded Disability Status Scale (EDS) 0-6.5
- •Clinical stability defined as no MS exacerbation or change in disease modifying therapy for 60 days prior to screening.
- •Screening 6-minute walking test distance between 50m-500m, inclusive.
- •Written informed consent.
排除标准
- •use of 4-aminopyridine within 6 months of screening
- •Any contraindication to DER:
- •Allergy to DER
- •history of seizure disorder or history of EEG showing epileptiform activity
- •Renal insufficiency (estimated GFR <
- •Any condition that would exclude 6 minute walking testing:
- •Cardiac surgery or myocardial infarction within the last 3 months.
- •Severe aortic stenosis or hypertropic cardiomyopathy.
- •Pulmonary embolus or infarction in the last 6 months.
- •Uncontrolled hypertension by history or by screening or baseline diastolic blood pressure > 170, or systolic blood pressure >
- •Use of oxygen at home for 24 hours/day or severe lung disease.
- •History of ventricular arrhythmia or finding of significant ventricular arrhythmia. atrial arrhythmia or 2nd or 3rd degree heart block on screening ECG.
- •Concomitant neurological disease, such as ALS, Parkinson Disease, stroke.
- •Hospitalization in the last 6 months for psychiatric illness.
- •Alcohol or drug abuse within the past year.
- •Females who are breast-feeding, pregnant or have potential to become pregnant during the course of the study( fertile and unwilling/unable to use effective contraceptive measures)
- •Cognitive deficits that would interfere with the subject's ability to give informed consent or preform study testing.
- •Any other serious and/or unstable medical condition.
- •Use of mitoxantrone (Novantrone) within 6 months of baseline visit.
研究组 & 干预措施
dalfampridine ER 10mg bid-placebo
4 week administration of dalfampridine ER 10mg bid followed by 2 week washout and 4 weeks of placebo control
干预措施: dalfampridine ER (Drug)
dalfampridine ER 10mg bid-placebo
4 week administration of dalfampridine ER 10mg bid followed by 2 week washout and 4 weeks of placebo control
干预措施: placebo (Drug)
placebo-dalfampridine ER 10mg bid
placebo tablet administered bid for four weeks followed by 2 week washout and 4 weeks of dalfampridine ER 10mg bid
干预措施: dalfampridine ER (Drug)
placebo-dalfampridine ER 10mg bid
placebo tablet administered bid for four weeks followed by 2 week washout and 4 weeks of dalfampridine ER 10mg bid
干预措施: placebo (Drug)
结局指标
主要结局
Peak Activity Index
时间窗: 10 weeks
peak activity index is a measure of the 30 fastest minutes of walking over a 24 hour period, averaged over one week of accelerometer wear. Measurement is change from baseline to 4 weeks on intervention
次要结局
- Stepcount(10 weeks)
研究者
Theodore R Brown
Principle Investigator
Brown, Theodore R., M.D., MPH