Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2019-001885-14
    Sponsor's Protocol Code Number:LOWBACK-SE
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-05-29
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2019-001885-14
    A.3Full title of the trial
    The prognostic value of Biomarkers and the Effect of Tolperisone in Acute low back pain and sciatic pain – BETA
    A Phase 3 investigator initiated study
    Biomarkerek prognosztikus Értéke és az izomrelaxáns Tolperison hatása Acut lumbagóban és lumboischialgiában - BÉTA.
    3. fázisú nem kereskedelmi klinikai vizsgálat
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The value of blood measurements, ultrasound an muscle electric studies to fortell the outcome of low back pain and sciatic pain and to evaluate the effect of the muscle relaxant tolperison
    Vérből vizsgálható anyagok, ultrahang- és izomelektromos vizsgálatok értéke a lumbágó és az isiász kórlefolyásának meghatározására és az izomlazító tolperison hatásának megítélésére
    A.3.2Name or abbreviated title of the trial where available
    BETA
    BÉTA
    A.4.1Sponsor's protocol code numberLOWBACK-SE
    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 SponsorNational Research, Development and Innovation Office
    B.1.3.4CountryHungary
    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 supportNational Research, Development and Innovation Office
    B.4.2CountryHungary
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSemmelweis University
    B.5.2Functional name of contact pointDepartment of Neurology
    B.5.3 Address:
    B.5.3.1Street AddressBalassa u. 6.
    B.5.3.2Town/ cityBudapest
    B.5.3.3Post codeH-1083
    B.5.3.4CountryHungary
    B.5.4Telephone number3612100337
    B.5.5Fax number3612101368
    B.5.6E-mailbereczki.daniel@med.semmelweis-univ.hu
    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 Miderizone 150 mg tablet
    D.2.1.1.2Name of the Marketing Authorisation holderMEDITOP Pharmaceutical Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationHungary
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute low back pain with or withour radicular signs
    Akut derékfájdalom gyöki tünetek nélkül (lumbago) vagy gyöki tünetekkel (lumboischialgia)
    E.1.1.1Medical condition in easily understood language
    Acute low back pain
    Akut derékfájdalom (lumbágó és isiász)
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main purpose of the trial is to identify biomarkers from the blood as well as electrophysiological and morphological features (chemical, electrophysiological and ultrasound biomarkers) that reflect the intensity of pain and/or fortell the efficacy of pharmacological (non-surgical) treatment in patients with acute low back pain.
    A tervezett kutatás célja a fájdalom intenzitását tükröző, a gyógyszeres kezelés hatékonyságát előrejelző, vérből kimutatható jelzőanyagok, valamint elektrofiziológiai és morfológiai jellemzők (kémiai, elektrofiziológiai és ultrahang biomarkerek) azonosítása akut derékfájdalomban szenvedő betegeknél.
    E.2.2Secondary objectives of the trial
    Not applicable
    Nincs
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients aged 18-80 years with acute (less than 1-month) low back pain with or without radicular signs, who do not have severe diseases (abscess, tumor etc) in the background, had CT or MRI scan, and who has given written consent to participte in the study.
    Acut (egy hónapnál rövidebb ideje fennálló) derékfájdalomban szenvedő, 18-80 év közötti betegek, akiknél MRI vagy CT vizsgálat történt, a fájdalom hátterében gyöki kompresszióval járó vagy azzal nem járó kórkép áll, a fájdalom hátterében tumor vagy tályog nincsen, és a beteg írásos beleegyezését adta a vizsgálatban való részvételhez.
    E.4Principal exclusion criteria
    Pregnancy, hypesensitivity to tolperisone in the history, severe liver or kidney disease, other severe diseases (abscess, tumor etc) in the background of pain.
    Graviditás, anamnesisben szereplő tolperison túlérzékenység, súlyos vese- vagy májkárosodás), egyéb súlyos kórok (tályog, tumor) a fájdalom hátterében.
    E.5 End points
    E.5.1Primary end point(s)
    Change in the level of biomarkers by the end of the treatment period compared to the pretreatment values.
    A biomarkerek szintjének változása a kezelési periódus végére a kezelés előtti értékhez képest.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Pretreatment value (Day 0)
    Daily report of patients on pain features (Days 0 - 14)
    End of treatment values (Day 14 +/- 3)
    Kezelés előtti érték (0. nap)
    Napi jelentések a betegtől a fájdalom jellemzőiről (0 - 14. napok)
    Kezelés végi érték (14 +/- 3 nap)
    E.5.2Secondary end point(s)
    • Change in the level of biomarkers with ceased or greatly reduced pain/paravertebral défense
    • Change in pain intensity by the end of the treatment period
    • Change in the level of biomarkers after 2 weeks of tolperisone treatment
    • Change in the level of paravertebral muscle contraction by the end of the treatment period
    • Predictive value of the initial levels of biomarkers
    • A serum biomarkerek szintjének változása megszűnt vagy jelentősen csökkent fájdalom/paravertebralis défense elérésekor
    • A fájdalom változása a kezelés végére
    • A serum biomarkerek szintjének változása két hét tolperison kezelés után
    • A paravertebralis izomkontrakció mértékének változása a kéthetes kezelés végére
    • A biomarkerek kezdeti értékének prediktív értéke
    E.5.2.1Timepoint(s) of evaluation of this end point
    Pretreatment value (Day 0)
    Endf of treatment values (Day 14 +/- 3)
    Kezelés előtti érték (0. nap)
    Kezelés végi érték (14 +/- 3 nap)
    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 Yes
    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
    Prognosis (predicitve value of biomarkers)
    Prognózis (egyes biomarkerek prediktiv értéke)
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    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
    LVLS
    A vizsgálatban résztvevő utolsó beteg utolsó vizitje
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    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 state150
    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)
    None
    Nincs
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-08-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-17
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Wed Apr 24 09:44:39 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA