Semaglutide for Relapsing-remitting multiple sclerosis | Multiple sclerosis

Inclusion criteria

• {"criterion_text":"- 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.\n- • Male or female aged 18 to 60 years (inclusive) at the time of the first visit to this study.\n- • Able to understand the requirements and follow the procedures within this study.\n- • 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\n- • EDSS<5,\n- • Set on stable treatment of the underlying disease for at least three (3) months"}

Exclusion criteria

• {"criterion_text":"- Main • diabetes mellitus on diet, oral antidiabetic drugs or insulin\n- • other serious chronic diseases\n- • Acute pancreatitiswith a historyof\n- • oncological diseases\n- • long-term use of medications such as glucocorticoids, Antidepressants\n- • Severe renal impairment and kidney disease in the last stage.\n- • Severe hepatic impairment.\n- • Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transit ischemic attack in 90 days before the dateof screening.\n- • New Class IV congestive heart failure York Heart Association (NYHA).\n- • Historyof major surgical procedures involving the stomach or smallintestine potentially affecting the absorption of medicinal products and/or nutrients, as assessed by the\n- • Pregnancy\n- • breastfeeding\n- • Drug use or alcoholuse\n- • the presence of metal components in the body\n- • Known hypersensitivity to the investigational drug, excipients or hypersensitivity to a drug with a similar structure."}

Primary endpoints

• {"endpoint_text":"- Primary endpoint: Annualized change in brain volume and gray matter volume.\n- Serum neurofilament L level.","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Secondary end points: Insulin sensitivity through ISI Cederholm, ISI Matsuda, HOMA-IR and HOMA-IR2.\n- Scores in Symbol Digit Modalities Test (SDMT) and Stroop Test.","definition_or_measurement_approach":"- Insulin sensitivity measured by ISI Cederholm, ISI Matsuda, HOMA-IR and HOMA-IR2.\n- Cognitive function measured by SDMT and Stroop Test scores."}

Slovakia

Earliest CTIS Part Ii Submission Date

05-11-2024

Latest Decision Or Authorization Date

07-11-2024

Processing Time Days

2

Number Of Sites

1

Number Of Participants

1

Primary sponsor

Full Name

Comenius University Bratislava

Organisation Type

Educational Institution

Country Of Registered Address

Slovakia