2024-519235-42-00招募中2 期
Effects of GLP-1 analogue in multiple sclerosis
Comenius University Bratislava1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2024年11月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Primary endpoint: Annualized change in brain volume and gray matter volume. Serum neurofilament L level.
研究概览
简要总结
Primary objectives To determine the effect of a GLP-1 receptor agonist on chronic axonal damage and neurodegeneration in MS patients
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Main inclusion criteria • Must freely consent to participate in this trial and personally sign the informed consent prior to performing any procedure in this study. • Male or female aged 18 to 60 years (inclusive) at the time of the first visit to this study. • Able to understand the requirements and follow the procedures within this study. • Patients with a confirmed diagnosis of relapsing-remitting multiple sclerosis, with a worse prognosis due to higher disease activity, with a disease duration of at least 1 year • EDSS<5, • Set on stable treatment of the underlying disease for at least three (3) months
排除标准
- •Main • diabetes mellitus on diet, oral antidiabetic drugs or insulin • other serious chronic diseases • Acute pancreatitiswith a historyof • oncological diseases • long-term use of medications such as glucocorticoids, Antidepressants • Severe renal impairment and kidney disease in the last stage. • Severe hepatic impairment. • Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transit ischemic attack in 90 days before the dateof screening. • New Class IV congestive heart failure York Heart Association (NYHA). • Historyof major surgical procedures involving the stomach or smallintestine potentially affecting the absorption of medicinal products and/or nutrients, as assessed by the • Pregnancy • breastfeeding • Drug use or alcoholuse • the presence of metal components in the body • Known hypersensitivity to the investigational drug, excipients or hypersensitivity to a drug with a similar structure.
结局指标
主要结局
Primary endpoint: Annualized change in brain volume and gray matter volume. Serum neurofilament L level.
Primary endpoint: Annualized change in brain volume and gray matter volume. Serum neurofilament L level.
次要结局
- Secondary end points: Insulin sensitivity through ISI Cederholm, ISI Matsuda, HOMA-IR and HOMA-IR2. Scores in Symbol Digit Modalities Test (SDMT) and Stroop Test.
研究者
prof. MUDr. Peter Turčáni, PhD.
Scientific
Comenius University Bratislava
研究点 (1)
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