E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
Naša hypotéza je, že pacienti so SM majú poruchu energetického metabolizmu v neurónoch a gliálnych bunkách CNS, čo prispieva k vzniku a progresii demyelinizačných ložísk a k neurodegenerácii, a čo sa prejavuje inzulínovou rezistenciou tak v periférnych tkanivách ako aj v CNS. |
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E.1.1.1 | Medical condition in easily understood language |
Our hypothesis is that patients with MS have a disorder of energy metabolism in neurons and glial cells of the CNS, manifested by insulin resistance in both peripheral tissues and the CNS. |
Naša hypotéza je, že pacienti so SM majú poruchu energetického metabolizmu v neurónoch a gliálnych bunkách CNS, čo sa prejavuje inzulínovou rezistenciou tak v periférnych tkanivách ako aj v CNS. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10063399 |
E.1.2 | Term | Relapsing-remitting multiple sclerosis |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
• Annualized change in brain volume and gray matter volume • Serum neurofilament L level |
• Anualizovaná zmena objemu mozgu a objemu sivej hmoty • Hladina neurofilamentu L v sére
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E.2.2 | Secondary objectives of the trial |
• Insulin sensitivity through ISI Cederholm, ISI Matsuda, HOMA-IR and HOMA-IR2 • Symbol Digit Modalities test (SDMT) and Stroop test scores according to normal workplace practice |
• Inzulínová citlivosť prostredníctvom ISI Cederholm, ISI Matsuda, HOMA-IR a HOMA-IR2 • Skóre v Symbol Digit Modalities teste (SDMT) a v Stroopovom teste vykonané podľa bežnej praxe pracoviska
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
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). |
Účastník musí slobodne súhlasiť s účasťou v tomto skúšaní a vlastnoručne podpísať informovaný súhlas pred vykonaním akejkoľvek procedúry v rámci tejto štúdie. • Muž alebo žena vo veku 18 až 60 rokov (vrátane) v čase prvej návštevy v rámci tejto štúdie. • Schopný porozumieť požiadavkám a dodržiavať procedúry v rámci tejto štúdie. • pacienti s potvrdenou diagnózou sklerózy multiplex, s horšou prognózou vzhľadom na vyššiu aktivitu ochorenia • EDSS<5, • Nastavení na stabilnej liečbe natalizumabom (Tysabri, Elan Pharma International Ltd., Monksland, Athlone, County Westmeath, Írsko).
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E.4 | Principal exclusion criteria |
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. |
Hlavné • diabetes mellitus na perorálnych antidiabetikách alebo inzulíne • iné závažné chronické ochorenia • onkologické ochorenia • dlhodobé užívanie liekov ako sú napr. glukokortikoidy, antidepresíva • tehotenstvo • dojčenie • užívanie drog alebo abúzus alkoholu • prítomnosť kovových komponentov v organizme • Známa precitlivenosť na skúšaný liek, pomocné látky lieku alebo precitlivenosť na liek s podobnou štruktúrou. Iné • Účasť na inej klinickej štúdii počas posledných 3 mesiacov pred zaradením alebo súčasná účasť na iných klinických štúdiách • Predchádzajúce zaradenie do liečby počas tejto štúdie • Úzke spojenie s hlavným skúšajúcim (napr. blízky príbuzný) alebo skúšajúcimi či zamestnancami pracoviska. • Účastník je zamestnancom zadávateľa • Kritériá, ktoré podľa názoru skúšajúceho vylučujú účasť z vedeckých dôvodov alebo z dôvodov bezpečnosti účastníka.
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E.5 End points |
E.5.1 | Primary end point(s) |
To determine the effect of GLP-1 receptor agonist on chronic axonal damage and neurodegeneration in patients with MS • Annualized change in brain volume and gray matter volume • Serum neurofilament L level |
Zistiť vplyv agonistu GLP-1 receptorov na chronické axonálne poškodenie a neurodegeneráciu u pacientov s SM • Anualizovaná zmena objemu mozgu a objemu sivej hmoty • Hladina neurofilamentu L v sére
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
end of trial participation / month 12 |
na konci účasti v skúšaní / 12. mesiac |
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E.5.2 | Secondary end point(s) |
To determine the effect of GLP-1 receptor agonist on insulin sensitivity in patients with MS • Insulin sensitivity through ISI Cederholm, ISI Matsuda, HOMA-IR and HOMA-IR2 HOMA-IR = (10 x G0) / 22.5 HOMA2 (http://www.dtu.ox.ac.uk/homacalculator/)
To determine the effect of GLP-1 receptor agonist on cognitive functions in patients with SM • Score in Symbol Digit Modalities Test (SDMT) and Stroop Test |
Zistiť vplyv agonistu GLP-1 receptorov na inzulínovú citlivosť u pacientov s SM • Inzulínová citlivosť prostredníctvom ISI Cederholm, ISI Matsuda, HOMA-IR a HOMA-IR2
HOMA-IR = (I0 x G0)/22.5 HOMA2 (http://www.dtu.ox.ac.uk/homacalculator/)
Zistiť vplyv agonistu GLP-1 receptorov na kognitívne funkcie u pacientov s SM • Skóre v Symbol Digit Modalities teste (SDMT) a v Stroopovom teste
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
end of trial participation / month 12 |
na konci účasti v skúšaní / 12. mesiac |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
exploratory investigation - signal searching |
výskumné skúšanie - hľadanie náznakov pozitívneho účinku liečby |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
skúšaným liekom neliečená skupina |
not IMP treated arm |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LSLV |
ukončenie účasti posledného účastníka |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |