CTIS2023-503190-38-00招募中1 期
Metformin add-on clinical study in multiple sclerosis to evaluate brain remyelination and neurodegeneration: a phase IIb triple-blind placebo-controlled randomized clinical trial (MACSiMiSE-BRAIN) - MACSiMiSE-BRAIN_v1.0
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 120
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 65+（—）
- 性别
- All
入选标准
- •A diagnosis of non-active progressive multiple sclerosis (including PPMS and SPMS, in accordance with 2017 revisions of McDonald criteria and disease course definitions of Lublin 2013), as evidenced by: a. the absence of relapses and new T2 lesions and/or enhancing T1 lesions on brain MRI in the past 1-2 years or longer (NEDA-2) b. progression of disability independent of relapses in the past 1-2 years or longer If progression is defined as one of the following, over the past 1-2 years or less, the patient can be included without additional review: •minimum increase in the EDSS of 1.0, or 0.5 from a baseline level of 2.0–5.0, and 5.5-6.0, respectively •=20% in the T25W •=20% 9HPT (on average of both hands and/or the dominant hand and/or the non-dominant hand) •reduction of =4 points or a 10% worsening in the Symbol Digit Modality Test without concomitant depression or fatigue If the investigator is in the opinion that the patient is clearly progressing, but not enough data are available to demonstrate this, a narrative needs to be provided, which will be judged by at least 2 members of the TSC, from a center that is not submitting the case for review., Age 18-70 years inclusive, EDSS 2.0-6.5 inclusive, Able to give informed consent (signed, written) and to adhere to study procedures, Dutch/Flemish and French speaking (patient reported outcomes and questionnaires available in Dutch/Flemish and French), Stable use of DMT or no treatment in the past year or longer, Use of adequate contraceptive measures in females of reproductive age
排除标准
- •A medical or neurological problem other than MS that is a cause of progressive or fluctuating gait dysfunction, Current use of metformin or known intolerance for metformin, Diagnosis of diabetes mellitus or fasting glucose level of 126mg/dl or more; random glucose level of 200mg/dl or more; HbA1C of 6.5% or more at screening, Unable to complete T25FW, Unable to undergo MRI, Current major disease or disorder other than MS (e.g., active malignancy, significant renal insufficiency eGFR <60 mL/min/1.73 m2, end-stage cardiopulmonary disease, alcoholism, liver insufficiency with AST >3 times ULN, chronic active infection etc.) that may interfere with study procedures and/or intake of study drug., Pregnant or breast-feeding or planning pregnancy, Use of an experimental therapy in the past 6 months, Ongoing immune reconstitution therapy schedule (cladribine second course ended at least 12 months before inclusion, alemtuzumab second/last course at least 12 months before inclusion, AHSCT at least 12 months before inclusion), Expected change in ongoing DMT or start of DMT if untreated
研究者
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