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    Summary
    EudraCT Number:2019-003001-94
    Sponsor's Protocol Code Number:MSGLP
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2019-09-13
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2019-003001-94
    A.3Full title of the trial
    Use of GLP-1 analogs in the treatment of multiple sclerosis
    Použitie GLP-1 analógov v terapii sklerózy multiplex
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Use of GLP-1 analogs in the treatment of multiple sclerosis
    Použitie GLP-1 analógov v terapii sklerózy multiplex
    A.3.2Name or abbreviated title of the trial where available
    MSGLP
    MSGLP
    A.4.1Sponsor's protocol code numberMSGLP
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLekárska fakulta UK Bratislava
    B.1.3.4CountrySlovakia
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMinistry of Health
    B.4.2CountrySlovakia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLekárska fakulta UK Bratislava
    B.5.2Functional name of contact pointProf. MUDr. Peter Turčáni, PhD.
    B.5.3 Address:
    B.5.3.1Street AddressŠpitálska 24
    B.5.3.2Town/ cityBratislava
    B.5.3.3Post code813 72
    B.5.3.4CountrySlovakia
    B.5.6E-mailturcani1@gmail.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Trulicity 0,75 mg injekčný roztok naplnený v injekčnom pere.
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V.
    D.2.1.2Country which granted the Marketing AuthorisationSlovakia
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTrulicity 0,75 mg injekčný roztok naplnený v injekčnom pere
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical 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.
    E.1.1.1Medical 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.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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
    E.2.2Secondary 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
    E.2.3Trial contains a sub-study No
    E.3Principal 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).
    E.4Principal 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.
    E.5 End points
    E.5.1Primary 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
    E.5.1.1Timepoint(s) of evaluation of this end point
    end of trial participation / month 12
    na konci účasti v skúšaní / 12. mesiac
    E.5.2Secondary 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
    E.5.2.1Timepoint(s) of evaluation of this end point
    end of trial participation / month 12
    na konci účasti v skúšaní / 12. mesiac
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    exploratory investigation - signal searching
    výskumné skúšanie - hľadanie náznakov pozitívneho účinku liečby
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    skúšaným liekom neliečená skupina
    not IMP treated arm
    E.8.2.4Number of treatment arms in the trial2
    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.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial 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
    LSLV
    ukončenie účasti posledného účastníka
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2019-09-13. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 50
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Upon completion of the clinical trial, patients will receive standard medical care customary for this type of disease.
    Po ukončení účasti v klinickom skúšaní bude pacientom poskytnutá štandardná lekárska starostlivosť, obvyklá pre tento druh ochorenia.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation BMC SAV Bratislava
    G.4.3.4Network Country Slovakia
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-11-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-14
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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