This is a Multi-center, Double-blind, Three Arm, Parallel Group, Placebo-controlled, Randomized Study Designed to Evaluate the Efficacy, Safety and Tolerability of Dalfampridine.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 377
- 试验地点
- 74
- 主要终点
- Proportion of Subjects Who Show at Least a 20% Improvement on the Two Minute Walk Test (2MinWT) at Week 12
研究概览
简要总结
The objective of this study is to determine the effect of two dose strengths of dalfampridine-Extended Release (ER) tablets, taken twice daily for 12 weeks, on stable walking deficits in subjects with post-ischemic stroke.
详细描述
This was a randomized, placebo-controlled, three-arm, parallel-group study designed to evaluate the efficacy, safety, and tolerability of dalfampridine extended release (ER) tablets on chronic walking deficits in subjects with post-ischemic stroke.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical evidence of a stable walking deficit due to an ischemic stroke, as judged by the Investigator, based on review of medical records and physical exam. Such deficit was not present prior to the stroke and cannot be attributed primarily to other conditions (e.g. chronic obstructive pulmonary disease, arthritis). Evidence of walking deficits is objectively supported by any one of the following findings on clinical examination:
- •obvious slowness of movement assigned primarily to the stroke
- •use of an assistive walking device such as a cane or walker
- •Presence of movement pattern deviations such as stiff-legged gait, foot drop, hip hiking and hip circumduction
- •Modified Rankin Scale score of 1 - 3, regardless of the cause(s) of the disability
- •Sufficient ambulatory ability to independently complete the 2MinWT and 10MWT
- •≥ 6 months from occurrence of most recent stroke
排除标准
- •Woman who is not surgically sterile or is less than 2 years postmenopausal, and does not agree to use a highly effective birth control method during the study and up to 3 months after the last dose of investigational product.
- •Woman who is pregnant, breastfeeding, or planning to become pregnant
- •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
- •Suicide attempt within 1 year prior to the Screening Visit, or severe suicidal ideation within 6 months prior to the Screening Visit, or subject is at significant risk of suicidal behavior in the opinion of the Investigator
- •Previous use of AMPYRA, dalfampridine, fampridine or 4-aminopyridine (4-AP)
- •Initiation of a serotonin reuptake inhibitor (SSRI) within 3 months prior to the Screening Visit, or any change in dosing regimen within 3 months prior to the Screening Visit
- •Botulinum toxin use within 2 months prior to the Screening Visit
- •Orthopedic surgical procedures in any of the extremities within the past 6 months
研究组 & 干预措施
Placebo
Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.
干预措施: Placebo (Drug)
dalfampridine-ER 7.5 mg
Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.
干预措施: dalfampridine-ER 7.5mg (Drug)
dalfampridine-ER 10mg
Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.
干预措施: dalfampridine-ER 10mg (Drug)
结局指标
主要结局
Proportion of Subjects Who Show at Least a 20% Improvement on the Two Minute Walk Test (2MinWT) at Week 12
时间窗: Week 12
"The 2MinWT measures the distance a subject can walk in 2 minutes. Participants showing at Least a 20% Improvement on the 2MinWT at 12-weeks are considered "Responders".
次要结局
- Change From Baseline on the Walking Impact Scale (Walk-12) at Week 12 (Key Secondary)(Baseline, week 12)