A Phase 2b Study of Dalfampridine 10mg Extended Release Tablet in Subjects With Chronic Deficits After Ischemic Stroke
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 20
- 主要终点
- Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
This is a multi-center, safety and tolerability study in subjects with chronic stable sensorimotor deficits after ischemic stroke. It has been designed as a double-blind, placebo-controlled, 2-period crossover study.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of a stable sensorimotor deficit due to an ischemic stroke, as confirmed by the Investigator with supportive prior imaging findings (MRI/ CT scan)
- •≥ 6 months post-stroke
- •Have a body mass index (BMI) ranging between 18.0 - 35.0 kg/m,2 inclusive
- •Stable concomitant medication therapy regimen within 4 weeks of screening visit
排除标准
- •History of seizures, except simple febrile seizures
- •Moderate or severe renal impairment as defined by a calculated creatinine clearance of ≤ 50 mL/minute using the Cockcroft-Gault Equation
- •Botulinum toxin use within 2 months prior to the Screening Visit
- •Orthopedic surgical procedures in any of the extremities within the past 6 months
- •Diagnosis of multiple sclerosis
研究组 & 干预措施
placebo/dalfampridine-ER
Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study:
Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36
干预措施: placebo/dalfampridine-ER (Drug)
dalfampridine-ER/placebo
Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study:
Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36
干预措施: dalfampridine-ER/placebo (Drug)
结局指标
主要结局
Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs)
时间窗: up to 36 days
A TEAE is defined as any adverse event with date of onset (or worsening) on or after the start-date of double-blind treatment through 7 days after the last dose of double-blind treatment. The severity categories of mild, moderate or severe, are defined below: * Mild is defined as causing no limitation of usual activities * Moderate is defined as causing some limitation of usual activities * Severe is defined as causing inability to carry out usual activities
次要结局
未报告次要终点