Phase 3 Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects With Multiple Sclerosis Who Participated in the MS-F203 Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 269
- 试验地点
- 63
- 主要终点
- Summary of Treatment Emergent Adverse Events (TEAE).
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and activity of Fampridine-SR when administered for up to 36 additional months, or until it becomes commercially available whichever comes first, in subjects who previously participated in Acorda Therapeutics Protocol MS-F203.
详细描述
Multiple Sclerosis (MS) is a disorder of the body's immune system that affects the central nervous system (CNS). Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with MS, the fatty sheath that surrounds and insulates the nerve fibers (called "myelin") deteriorates, causing nerve impulses to be slowed or stopped. As a result, patients with MS may experience periods of muscle weakness and other symptoms such as numbness, loss of vision, loss of coordination, paralysis, spasticity, mental and physical fatigue and a decrease in the ability to think and/or remember. These periods of illness may come (exacerbations) and go (remissions). Fampridine-SR is an experimental drug that has been reported to possibly improve muscle strength and walking ability for some people with MS. This study will evaluate the effects and possible risks of taking Fampridine-SR in MS patients over a long period of time.
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
- •subject must have been previously enrolled in Acorda Therapeutics MS-F203 study for multiple sclerosis and received either Fampridine-SR or placebo
- •subject is a man or woman with clinical definite multiple sclerosis as defined by McDonald (McDonald WI, et al. Recommended Diagnostic Criteria for Multiple Sclerosis; Guidelines from the International Panel on the Diagnosis of Multiple Sclerosis; Annals of Neurology. 2001; 50: 121-127)
- •subject must be at least 18 years of age. Any subject who is now over the age of 70 must be in good overall health in the judgment of the Investigator
- •subject must be of adequate cognitive function, as judged by the Investigator, to understand and sign the IRB/REB-approved informed consent form prior to the performance of any study-specific procedures and is willing to comply with the required scheduling and assessments of the protocol
- •subjects who are women of childbearing potential, regardless of sexual activity, must have a negative urine pregnancy test at the Screening Visit.
排除标准
- •women who are either pregnant or breastfeeding, and women of childbearing potential (defined as not surgically sterile or at least two years post menopausal) who are engaged in active heterosexual relations and, are not using one of the following birth control methods: tubal ligation, implantable contraception device, oral, patch, injectable or transdermal contraceptive, barrier method or sexual activity restricted to vasectomized partner.
- •subject discontinued prematurely from the MS-F203 study
- •subject has a history of seizures or has evidence of past, or possible, epileptiform activity on an EEG
- •subject has either a clinically significant abnormal ECG or laboratory value(s) at the Screening visit, as judged by the Investigator that would preclude entry into the study. ECG and laboratory results from Visit 6 or repeat results from Visit 7 of the MS-F203 study may be used as the baseline for the current study
- •subject has angina, uncontrolled hypertension, clinically significant cardiac arrhythmias, or any other clinically significant cardiovascular abnormality, as judged by the Investigator
- •subject has a known allergy to pyridine-containing substances or any of the inactive ingredients of the Fampridine-SR tablet (hydroxypropyl methylcellulose, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, opadry white (tablet film coating))
- •subject has received an investigational drug, except for Fampridine-SR or matching placebo under protocol MS-F203, within 30 days of the Screening Visit. Subject is scheduled to enroll in an investigational drug trial at any time during this study.
- •subject has a history of drug or alcohol abuse within the past year
结局指标
主要结局
Summary of Treatment Emergent Adverse Events (TEAE).
时间窗: up to 5 years
All adverse events reported were treatment emergent. Therefore, events that had a date of onset, or worsening, on or after the start of the open-label drug and up to 14 days after the last dose (for non-serious events) or up to 30 days after the last dose (for SAEs) were summarized. Any abnormal clinically significant changes in physical examination, medical history, clinical laboratory testing, 12-lead ECG, and standard EEG testing were captured as adverse events.
次要结局
- Timed 25 Foot Walk (T25FW)(Week 2, 14, 26, continuing every 26 weeks until the Final Visit)
- Subject Global Impression (SGI)(visit 1 and every clinic visit)
- Clinician Global Impression of Change (CGIC)(visit 1 and every clinic visit)
- Expanded Disability Status Scale (EDSS)(Screening visit, visit 6 and every 24 months thereafter)