Open-Label Extension Study to Evaluate the Safety and Tolerability of Oral Fampridine SR in Canadian Subjects With Multiple Sclerosis Who Participated in Acorda Extension Trials
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 38
- 试验地点
- 5
- 主要终点
- Adverse events (AEs) and serious adverse events (SAEs) as well as Changes in vital signs and clinical laboratory assessments
研究概览
简要总结
The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB041 (fampridine-sustained release (SR)) treatment in Canadian participants with multiple sclerosis (MS) who previously participated in the registrational and extension studies conducted by Acorda. Those studies include NCT00654927 (MS-F202EXT), NCT00648908 (MS-F203EXT) and NCT00649792 (MS-F204EXT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Discontinued prematurely from the preceding study ((MS-F202EXT, MS-F203EXT, or MS-F204EXT).
- •Any prior history of seizure, epilepsy, or other convulsive disorder.
- •Any clinically significant abnormal laboratory values.
- •New history of moderate or severe renal impairment.
- •New history of angina, uncontrolled hypertension, clinically significant cardiac arrhythmias, or any other clinically significant cardiovascular abnormality, as judged by the Investigator.
- •Any significant change in overall health that would preclude subject's participation in the study, in the opinion of the Investigator.
- •Known allergy to pyridine-containing substances or any of the inactive ingredients of the fampridine-SR tablet
- •Received an investigational drug, except fampridine-SR under the preceding study (MS-F202EXT, MS-F203EXT, or MS-F204EXT), within the last 30 days, or the subject is scheduled to enroll in an investigational drug at any time during the study.
- •A history of drug or alcohol abuse within the past year.
- •Treatment with other forms of fampridine or 4-AP (e.g., compounded formulation of 4-AP) or 3,4-diaminopyridine (3,4-DAP).
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
BIIB041 (Fampridine-SR)
Participants take 10 mg sustained-release tablets of fampridine twice daily for up to 27 months or until the product is commercially available.
干预措施: BIIB041 (Fampridine-SR) (Drug)
结局指标
主要结局
Adverse events (AEs) and serious adverse events (SAEs) as well as Changes in vital signs and clinical laboratory assessments
时间窗: From Screening (Day 0) to Termination (Month 27)
次要结局
未报告次要终点