NL-OMON37416已完成4 期
An Open-Label, Multicenter, Multinational Study to Assess the Effect of Long Term Prolonged Release Fampridine (BIIB041) 10 mg Twice Daily on Quality of Life as Reported by Subjects with Multiple Sclerosis - ENABLE 218MS403
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Male or female subjects, 18 to 75 years old, inclusive, at the time of informed consent.
- •2. Must have a diagnosis of primary progressive, secondary progressive, progressive remitting, or relapsing remitting MS per revised McDonald Committee criteria as defined by Lublin and Reingold of at least 3 months duration.
- •3. Have a walking impairment as determined by the Investigator.
- •4. Able to perform the T25FW test with or without a walking aid.
- •5. Female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
排除标准
- •1. Known allergy to pyridine-containing substances or to any of the inactive ingredients in the prolonged release fampridine tablet.
- •2. Any history of seizure, epilepsy, or other convulsive disorder, with the exception of febrile seizures in childhood.
- •3. An estimated CrCl of <80 mL/minute.
- •4.Subject needs to take medicinal products that are inhibitors of organic cation transporter 2 (OCT2 [e.g., cimetidine]).
- •5.Previous exposure to fampridine.
研究者
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