EUCTR2011-003507-38-NL进行中（未招募）不适用
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
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •To be eligible to participate in this study, candidates must meet the following eligibility criteria at the Screening Visit or at the timepoint specified in the individual eligibility criterion listed:
- •1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
- •2. Male or female subjects, 18 to 75 years old, inclusive, at the time of informed consent.
- •3. Must have a diagnosis of primary-progressive, secondary-progressive, progressive-remitting, or relapsing-remitting MS per revised McDonald Committee criteria (Section 22.1 [Polman et al, 2011]) as defined by Lublin and Reingold [Lublin and Reingold 1996] of at least 3 months duration.
- •4. Have a walking impairment as determined by the Investigator.
- •5. Able to perform the T25FW (Section 22.2) test with or without a walking aid.
- •6. 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. For further details of contraceptive requirements for this study, please refer to Section 15.5.3.
- •7. Able to understand and comply with the requirements of the protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 640
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 160
排除标准
- •Candidates will be excluded from study entry if any of the following exclusion criteria are met at the Screening Visit or at any time during the screening period, or at the timepoint specified in the individual eligibility criterion listed:
- •Medical History
- •1. Known allergy to pyridine-containing substances or to any of the inactive ingredients (see Section 12.1) 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]).
- •Miscellaneous
- •5. Female subjects who are currently pregnant or who are considering becoming pregnant while participating in the study. Female subjects of childbearing potential who have a positive pregnancy test at the Screening Visit may not participate in this study.
- •6. Female subjects who are currently breastfeeding.
- •7. Previous exposure to fampridine.
研究者
相似试验
进行中（未招募）
不适用
ong-Term Prolonged-Release Fampridine Treatment and Quality of LifeMedDRA version: 14.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersMultiple SclerosisEUCTR2011-003507-38-DKBiogen Idec Research Limited800
进行中（未招募）
1 期
ong-Term Prolonged-Release Fampridine Treatment and Quality of LifeMedDRA version: 15.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersMultiple SclerosisEUCTR2011-003507-38-BEBiogen Idec Research Limited800
进行中（未招募）
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ong-Term Prolonged-Release Fampridine Treatment and Quality of LifeMedDRA version: 14.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersMultiple SclerosisEUCTR2011-003507-38-ITBIOGEN IDEC RESEARCH LTD800
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 SclerosisPlaques in central nervous system10007951NL-OMON37416Biogen90
进行中（未招募）
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ong-Term Prolonged-Release Fampridine Treatment and Quality of LifeMultiple SclerosisEUCTR2011-003507-38-PTBiogen Idec Research Limited800