2023-503190-38-00招募中2 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)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 5
- 主要终点
- Change in walking speed, measured by T25FW, between baseline and 96 weeks of treatment.
研究概览
简要总结
The primary objective is to determine if treatment with metformin is able to delay disease progression in comparison to placebo in patients with non-active progressive multiple sclerosis. It is hypothesized that metformin, as add-on treatment, in patients with PMS is superior to placebo in slowing disease progression. This will be measured by the primary outcome that is change in walking speed as measured by the T25FW between baseline and 96 weeks of treatment, between the control (placebo) and intervention (metformin) group.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
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
结局指标
主要结局
Change in walking speed, measured by T25FW, between baseline and 96 weeks of treatment.
Change in walking speed, measured by T25FW, between baseline and 96 weeks of treatment.
次要结局
- Change in 2 minute walk test between baseline and 96 weeks of treatment.
- Change in the Compisite endpoint as measured by Overall Disability Response Score (ODRS) between baseline and 96 weeks of treatment.
- Change in Expanded Disability Status Scale (EDSS) between baseline and after 96 weeks of treatment.
- Change in cognitive function as measured by Symbol Digit Modalities Test (SDMT) between baseline and 96 weeks of treatment.
- Change in hand function as measured by Nine-Hole Peg Test (9HPT) between baseline and 96 weeks of treatment.
- Change in brain volume (whole brain volume and gray matter volume) as measured by MRI from baseline to 48 weeks, from baseline to 96 weeks and from 48 to 96 weeks.
- Change in brain MRI-DTI metrics (fractional anisotropy (FA), mean diffusivity (MD) and radial diffusivity (RD)) from baseline to 48 weeks, from baseline to 96 weeks and from 48 to 96 weeks
- Change in quality of life as measured by EQ-5D-5L between baseline and 96 weeks of treatment.
- Change in quality of life as measured by Multiple Sclerosis Impact Scale-29 between baseline and 96 weeks of treatment.
- Change in number of SWI lesions from baseline to 48 weeks, from baseline to 96 weeks and from 48 to 96 weeks.
- Change in Modified Caregiver strain index (MCSI) from baseline to 96 weeks.
- Average total costs between baseline and 96 weeks of treatment and incremental cost-effectiveness ratio
研究者
Barbara Willekens
Scientific
Antwerp University Hospital
研究点 (5)
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