An Extension Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of Dalfampridine Extended-Release Tablets. for the Treatment of Chronic Post-Ischemic Stroke Walking Deficits .
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 294
- 试验地点
- 66
- 主要终点
- The Primary Objective Was to Evaluate Serious and Non-serious Adverse Events for Study Participants as a Measure of Safety and Tolerability of Dalfampridine ER (Extended Release) for at Least 12-months.
研究概览
简要总结
This is an extension study to evaluate the long-term safety, tolerability, and efficacy of two dose strengths of dalfampridine-ER.
详细描述
This is an extension study to evaluate the long-term safety, tolerability, and efficacy of two dose strengths of dalfampridine-ER twice daily tablets when administered for at least 12 months to subjects with chronic post-ischemic stroke walking deficits who have completed the controlled, double-blind Study DALF-PS-1016.
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
- •Completion of the DALF-PS-1016 study
- •Providing informed consent to continue into the DALF-PS-1029 long-term extension study
- •Sufficient ambulatory ability to independently complete the Two Minute Walk Test (2MinWT) and 10 Meter Walk Test (10MWT) at the time of enrollment into the extension study
排除标准
- •Seizures, new onset strokes (or other significant neurological event precluding long-term continuation) occurring during the antecedent DALF-PS-1016 study
- •Calculated creatinine clearance of ≤ 50 mL/minute at the time of enrollment into the long-term extension study
研究组 & 干预措施
dalfampridine-ER 7.5 mg
Dalfampridine-ER 7.5 mg tablets taken orally twice daily, approximately 12 hours apart.
Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study.
干预措施: dalfampridine-ER 7.5 mg (Drug)
dalfampridine-ER 10 mg
Dalfampridine-ER 10 mg tablets taken orally twice daily, approximately 12 hours apart.
Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study.
干预措施: dalfampridine-ER 10 mg (Drug)
结局指标
主要结局
The Primary Objective Was to Evaluate Serious and Non-serious Adverse Events for Study Participants as a Measure of Safety and Tolerability of Dalfampridine ER (Extended Release) for at Least 12-months.
时间窗: up to 12 months
This extension study was designed to evaluate long-term safety, tolerability, and efficacy of dalfampridine-ER (extended release) in adult subjects with chronic post-ischemic stroke walking deficits. Subjects who had completed the placebo-controlled DALF-PS-1016 core study were eligible to enroll regardless of whether they had received active drug or placebo in the core study.
次要结局
- Change From Baseline on the Two-Minute Walk Test (2MinWT)(Day 1, up to 12 months)
- Change From Baseline on the 10 Meter Walk Test (10MWT)(Day 1, up to 12 months)
- Change From Baseline on the Timed up and Go (TUG) Test(Day 1, up to 12 months)
- Change From Baseline on the Walking Impact Scale (Walk-12)(Day 1, up to 12 months)
- Change From Baseline on the Stroke Impact Scale (SIS)(Day 1, up to 12 months)
- Subject Global Impression (SGI)(Visit 8 (Month 12))
- Change From Baseline on the 12-item Health Survey (SF-12)(Day 1, up to 12 months)