se of GLP-1 analogs in the treatment of multiple sclerosis
- Conditions
- Our hypothesis is that patients with MS have a disorder of energy metabolism in neurons and glial cells of the CNS, contributing to the development and progression of demyelinating foci and neurodegeneration, and manifested by insulin resistance in both peripheral tissues and the CNS.MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2019-003001-94-SK
- Lead Sponsor
- ekárska fakulta UK Bratislava
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 50
The participant must freely agree to participate in this trial and sign the informed consent by hand prior to performing any procedure in this study.
• A man or woman aged 18 to 60 years (inclusive) at the time of the first study visit.
• Able to understand the requirements and follow the procedures of this study.
• patients with a confirmed diagnosis of multiple sclerosis, with a worse prognosis due to higher disease activity
• EDSS <5
• Adjustment to stable natalizumab treatment (Tysabri, Elan Pharma International Ltd., Monksland, Athlone, County Westmeath, Ireland).
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 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
main
• diabetes mellitus on oral antidiabetics or insulin
• other serious chronic diseases
• oncological diseases
• long-term use of medicines such as. glucocorticoids, antidepressants
• pregnancy
• breastfeeding
• drug use or alcohol abuse
• the presence of metal components in the body
• Known hypersensitivity to the test product, excipients, or hypersensitivity to a similar structure.
other
• Participation in another clinical study during the last 3 months before enrollment or concurrent participation in other clinical studies
• Previous treatment enrollment during this study
• Close connection with the principal examiner (eg a close relative) or the examiner or workplace staff.
• The participant is an employee of the client
• Criteria that, in the examiner's opinion, exclude participation for scientific or safety reasons of the participant.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method