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    Summary
    EudraCT Number:2011-002600-32
    Sponsor's Protocol Code Number:
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-07-19
    Trial results View 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 ConcernedAustria - BASG
    A.2EudraCT number2011-002600-32
    A.3Full title of the trial
    OLFACTORY NEURAL REPSONSES AS A MEASURE OF THERAPEUTIC SUCCESS IN PERSONS WITH OLFACTORY ANOSMIA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Neuronale Korrelate bei Anosmiker
    A.3.2Name or abbreviated title of the trial where available
    Anosmiker
    A.4.1Sponsor's protocol code number
    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 SponsorUniversitätsklinik für Radiodiagnostik, Abteilung für Neuroradiologie, Medizinische Universität Wien
    B.1.3.4CountryAustria
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinik für Radiodiagnostik, Abteilung für Neuroradiologie, Medizinische Universität Wien
    B.5.2Functional name of contact pointVeronika Schöpf
    B.5.3 Address:
    B.5.3.1Street AddressSpitalgasse 23
    B.5.3.2Town/ cityWien
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number004301404005751
    B.5.5Fax number004301404004864
    B.5.6E-mailveronika.schoepf@meduniwien.ac.at
    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 ACTRAPID NovoLet 40 I.E./ml
    D.2.1.1.2Name of the Marketing Authorisation holderNOVO-NORDISK A/S, BAGSVAERD / DK
    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.3.1Product nameACTRAPID
    D.3.2Product code A10AB01
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 9004-10-8
    D.3.10 Strength
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number40
    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 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 placeboSolution for infusion and oral solution
    D.8.4Route of administration of the placeboNasal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Die Hypothese dieser Studie ist es zu zeigen, dass es Patienten, die an funktioneller Anosmie leiden, möglich ist, Hirnregionen die bei der Verarbeitung von olfaktorisch Prozessen eine Rolle spielen, zu aktivieren. Weiters soll gezeigt werden, dass es durch gezieltes Riechtraining und der intranasalen Applikation von Insulin möglich ist diese Aktivität zu verbessern und somit die Riechfähigkeit zu fördern.
    E.1.1.1Medical condition in easily understood language
    Es soll gezeigt werden, dass es mittels gezieltem Riechtrainings und der Gabe von intranasalem Insulin möglich ist olfaktorische Prozesse bei Patienten mit funktioneller Anosmie wieder zu erlangen.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    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
    Derzeit gibt es keine allgemein anerkannten Therapiemethoden um die Riechfähigkeit betroffener Patienten zu verbessern. Hummel et al. (2009) konnten zeigen, dass ein Training der Geruchswahrnehmung die olfaktorische Leistung verbessern kann. Aus bisherigen psychophysiologischen Untersuchungen ist jedoch völlig unklar, ob und wie Anosmiker olfaktorische Information verarbeiten können und wie die Verarbeitung von olfaktorischer Information durch gezieltes Riechtraining modifiziert und verbessert werden kann.
    Vorgeschlagen werden zwei Therapiemethoden zur Verbesserung der Riechfähigkeit anosmischer PatientInnen. Neben einem 12wöchigen Riechtraining, welches zwei Mal täglich von den Patientinnen selbstständig durchgeführt werden soll, wird auch eine intranasale Insulinapplikation zur Steigerung der olfaktorischen Leistung angeboten (vgl. Marks et al., 2009).
    E.2.2Secondary objectives of the trial
    In diesem Projekt soll die grundlegende neurale Kodierung von Information im olfaktorischen Kortex bei funktionellen Anosmikern im Vergleich zu Gesunden untersucht werden. Weiters soll die neuronale Basis olfaktorischen Lernens bei Anosmikern beschrieben werden. Ziel dieser Studie ist es zu zeigen, dass durch gezielte Therapiebei funktionellen Anosmikern eine Veränderung der Hirnaktivität in olfaktorisch relevanten Gehirnregionen und somit eine Verbesserung der Riechwahrnehmung erreicht werden kann.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Untersucht werden 40 Anosmiker (hierfür wird die allgemein gültige Grenze eines TDI Scores von unter 15 festgelegt) und 40 gesunde Kontrollpersonen (normosmische TDI Scores nach Hummel et al. 2007) beider Geschlechter im Alter von 20-45 Jahren.
    E.4Principal exclusion criteria
    Für beiden Gruppen gelten folgende Ausschlusskriterien:
    • RaucherInnen
    • Herz-Kreislauf-Erkrankungen (z.B. Herzinfarkt, schwere Herzrhythmusstörungen, Angina pectoris (Brustenge durch gestörte Durchblutung des Herzens), Vasospasmen (Erkrankungen mit sich verengenden Blutgefässen), schwere Herzinsuffizienz, schwere periphere arterielle Verschlusskrankheit, arterieller Bluthochdruck)
    • Lungenerkrankungen (z.B. Asthma, andere Lungenerkrankungen)
    • häufiges oder innerhalb der letzten 3 Tage erlebtes Nasenbluten, chronische Nasenerkrankungen
    • Erkrankungen mit Beteiligung des ZNS (z.B. Schlaganfall, sog. zerebrovaskuläre Insuffizienz, Multiple Sklerose, Schädel-Hirn-Trauma)
    • Stoffwechselerkrankungen (z.B. Diabetes mellitus, Phäochromozytom (Tumor der Nebennierenriende), Schilddrüsenüber- oder -unterfunktion)
    • erhöhter Augeninnendruck, insbesondere Engwinkelglaukom
    • andere wesentliche Erkrankungen (z.B. Leberinsuffizienz, Niereninsuffizienz, Magen- oder Darmgeschwüre)
    • bekannte Allergien gegen die verwendeten Substanzen
    • Metallteile im Körper, insbesondere: Metallteile nach Operationen (z.B. künstliche Hüfte), Granatsplitter, Clips, Hörgeräte, herausnehmbarer Zahnersatz, Insulin- u. Zytostatikapumpen
    • Platzangst
    • Herzschrittmacher
    • Schwangerschaft
    • Operation an Kopf, Herz, Gefäßen
    • Medikamente von denen bekannt ist, dass sie die Riechfunktion beeinträchtigen
    • neurologische Erkrankungen (z. B. Alzheimer)
    • psychiatrische Erkrankungen (z. B. Depressionen, Schizophrenie)
    E.5 End points
    E.5.1Primary end point(s)
    Erfolgreiche Beendigung der Studie von 40 Anosmikern und 40 Kontrollprobanden
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 Jahre nach Beginn der Studie
    E.5.2Secondary end point(s)
    Die Studie wird abgebrochen, wenn bisher nicht bekannte, meldungspflichtige schwere Nebenwirkungen (wie z.B. Agoraphobie im Scanner, Angstattacken, schwere Atembeschwerden) in mindestens 3 Fällen bei StudienteilnehmerInnen auftreten.
    E.5.2.1Timepoint(s) of evaluation of this end point
    laufend
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    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
    OLFACTORY NEURAL REPSONSES
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    monozentrisch
    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.8.3 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.8.6 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 Yes
    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
    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 months
    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: 80
    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 Yes
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    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 Decision2011-09-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-08-07
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