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    Summary
    EudraCT Number:2009-016057-17
    Sponsor's Protocol Code Number:23349
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-06-16
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2009-016057-17
    A.3Full title of the trial
    Behandling med nerveaktiverende medicin efter apopleksi - måling af genoptræningseffekt, patologisk træthed, muskelstyrke og knogleafkalkning
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Behandling med nerveaktiverende medicin efter slagtilfælde
    A.4.1Sponsor's protocol code number23349
    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 SponsorGentofte Hospital
    B.1.3.4CountryDenmark
    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 supportForskningsrådet og fonde
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Modiodal
    D.2.1.1.2Name of the Marketing Authorisation holderCephalon Pharma ApS
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMODAFINIL
    D.3.9.1CAS number 68693118
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Apopleksi.
    E.1.1.1Medical condition in easily understood language
    Slagtilælde.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10042244
    E.1.2Term Stroke
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10048863
    E.1.2Term Hemorrhagic stroke
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10014498
    E.1.2Term Embolic stroke
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10019016
    E.1.2Term Haemorrhagic stroke
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10027580
    E.1.2Term Middle cerebral artery stroke
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10043647
    E.1.2Term Thrombotic stroke
    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
    At reducere patologisk træthed efter slagtilfælde
    E.2.2Secondary objectives of the trial
    At modvirke udvikling af knogleskørhed efter slagtilfælde.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Myndige personer af begge køn på mindst 18 år med apopleksi opstået inden for 14 dage.
    2. Forud for aktuel apopleksi skal modified Rankin Score (mRS) være mellem 0 og 3, og Barthelscore 85 eller mere, idet et betydende forudgående handicap gør det vanskeligt at vurdere et gunstigt behandlingsresultat.
    3. Patienter, som er i stand til at forstå instruktioner og generelt er i stand til at kooperere på test og spørgeskemaer selv eller via støtte.
    4. Patienter eller pårørende, som har afgivet informeret samtykke.
    5. Generel MFI-20 score > 12.
    6. Fertile kvinder testet negativt for graviditet og som anvender sikker antikonception.
    E.4Principal exclusion criteria
    1. Manglende evne til at medvirke i undersøgelsen selv eller via pårørende (f.eks. tilstedeværelse af demens eller neuropsykologiske dysfunktioner som bevirker, at patienten ikke kan forstå instruktioner; herunder komatøse og vegetative patienter).
    2. Tilstedeværelse af kendte faktorer udover apopleksi, der kan medføre invaliderende træthed.
    3. Apopleksi induceret af et traume, en infektion, en kirurgisk eller kardiovaskulær procedure.
    4. Stofmisbrug; test foretages umiddelbart efter accept af forsøgsdeltagelse.
    5. Graviditet eller usikker anvendelse af antikonception hos fertile kvinder.
    6. Kendte kontraindikationer vedr. behandling med modafinil og methylphenidat, som eksempelvis hjertearytmier, svær angina pectoris, udtalt hypertension og alkoholmisbrug (se Lægemiddelkataloget® for detaljer).
    7. Kendt aktiv malign lidelse, benign intrakraniel proces, subdural eller epidural blødning.
    8. Kendt, svær nyreinsufficiens (serumkreatinin >265 mikromol/l) eller leverdysfunktion (ASAT > 70 U/L for kvinder og 100 U/L for mænd) og levercirrose.
    9. Allergi mod anvendte forsøgsmedicin.
    10. Anvendelse af anden medicin, som kan medføre træthed. (Rescue-medicin, og anden medicin med kortvarig/akut virkning, må anvendes, også såfremt der herved induceres kortvarig påvirkning af træthed. Hvis en sådanne kortvarig effekt forekommer umiddelbart op til en test-situation, så aftales nyt undersøgelsestidspunkt.)
    E.5 End points
    E.5.1Primary end point(s)
    Nærværende projekt er en investigator-initieret, placebokontrolleret, dobbeltblindet og klinisk undersøgelse af apopleksiramte patienter med det hypotetiske udgangspunkt, at nerveaktiverende medikamenter vil modvirke invaliderende træthed samt forbedre kognitivt og psykomotorisk funktionsniveau.
    Den primære hypotese er således, at medicinsk behandling vil have positiv effekt på graden af adfærdsmæssigt og kognitivt funktionsniveau efter apopleksi, således at den neuroaktiverede gruppe vil opleve reduceret grad af invaliderende træthed. Endvidere forventes gruppen i højere grad at være vendt tilbage til præmorbidt aktivitets- og funktionsniveau.
    Undersøgelsen primære effektmål er en reduktion af træthed hos mindst 20 % af apopleksipatienter behandlet med nerveaktiverende medikamenter målt efter 6 måneders behandlingstid via MFI-20-testen (MFI = Multidimensional Fatigue Inventory, som består af 20 delspørgsmål).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Efter 6 måneders behandlingstid.
    E.5.2Secondary end point(s)
    Et særligt centralt sekundært effektmål er vurdering af trætheden efter 12 måneder, dvs. 6 måneder efter at patienterne modtog sidste medicinering mod trætheden. Anvendelse af MFI-20 som primært effektparameter følger en større videnskabelig undersøgelse af træthed hos apopleksipatienter, som blev udført med positivt resultat i Danmark i år 2008.
    Yderligere sekundære effektmål er måling af træthed efter behandlingstid på 14 dage, 1 måned, 3 måneder og 6 måneder samt, at medicinsk behandling vil medføre bedre muskelstyrke samt mindre knoglesvind relativt til placebo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Se E.5.2.
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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
    Når sidste af de 128 patienter er inkluderet og færdigbehandlet.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 128
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 64
    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 No
    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 state128
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 128
    F.4.2.2In the whole clinical trial 128
    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)
    Standardbehandling fortsættes.
    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 Decision2011-07-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-12-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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    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.

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