EUCTR2013-002113-35-FR进行中（未招募）1 期
Effect of MD1003 in spinal progressive multiple sclerosis: a pivotal randomized double blind placebo controlled study - MS-SPI
MEDDAY SAS0 个研究点目标入组 154 人开始时间: 2015年5月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 154
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
- •1) Diagnosis criteria of secondary or primary progressive MS with clinical or radiological evidence of spinal cord involvement fulfilling revised MacDonald criteria (2010) and Lublin criteria (1996)
- •2) Progression of the EDSS of at least 0.5 point during the past two years
- •3) EDSS score between 4.5 and 7 (measured beside a relapse and confirmed at 6 months)
- •4) Informed consent
- •5) Patient aged 18-64 years
- •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 105
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Any general chronic handicapping disease other than MS
- •2) Intensive physical therapy program within the 3 months prior to inclusion
- •3) Differences of the TW25 mean score between screening and baseline above 20%
- •4) New treatment introduced less than 3 months prior to inclusion or less than 1 month for Fampridine
- •5) Pregnancy or childbearing potential woman without contraception
研究者
相似试验
Unknown
3 期
Effect of MD1003 in Spinal Progressive Multiple SclerosisMultiple SclerosisNCT02220933MedDay Pharmaceuticals SA144
进行中（未招募）
1 期
Effect of MD1003 in progressive multiple sclerosis with walking impairmentMultiple sclerosisMedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2016-000700-29-BEMEDDAY PHARMACEUTICALS SA754
进行中（未招募）
1 期
Effect of MD1003 in progressive multiple sclerosis with walking impairmentMultiple sclerosisEUCTR2016-000700-29-HUMEDDAY PHARMACEUTICALS SA754
进行中（未招募）
1 期
Effect of MD1003 in progressive multiple sclerosis with walking impairmentMultiple sclerosisMedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2016-000700-29-DEMEDDAY PHARMACEUTICALS SA754
进行中（未招募）
1 期
Effect of MD1003 in progressive multiple sclerosis with walking impairmentMultiple sclerosisMedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2016-000700-29-ITMEDDAY PHARMACEUTICALS766