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:2014-000303-28
    Sponsor's Protocol Code Number:MW029
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-08-07
    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 ConcernedGermany - BfArM
    A.2EudraCT number2014-000303-28
    A.3Full title of the trial
    Multi-center, prospective, controlled, randomized, single-blinded study to evaluate the efficacy of vibrotactile neuro-feedback additionally to intake of Ginkgo biloba special extract EGb 761® for the treament of presby vertigo.
    Multizentrische prospektive kontrollierte randomisierte einfach-blinde Studie zur Wirksamkeit von vibrotaktilem Neurofeedback zusätzlich zu Ginkgo biloba Spezialextrakt EGb 761® zur Behandlung des Altersschwindels.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multi-center, prospective, controlled, randomized, single-blinded study to evaluate the efficacy of vibrotactile neuro-feedback additionally to intake of Ginkgo biloba special extract EGb 761® for the treament of presby vertigo.
    Multizentrische prospektive kontrollierte randomisierte einfach-blinde Studie zur Wirksamkeit von vibrotaktilem Neurofeedback zusätzlich zu Ginkgo biloba Spezialextrakt EGb 761® zur Behandlung des Altersschwindels.
    A.4.1Sponsor's protocol code numberMW029
    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 SponsorDr. Willmar Schwabe GmbH & Co. KG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDr. Willmar Schwabe GmbH & Co. KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDr. Willmar Schwabe GmbH & Co. KG
    B.5.2Functional name of contact pointMedical Affairs
    B.5.3 Address:
    B.5.3.1Street AddressWillmar-Schwabe Str. 4
    B.5.3.2Town/ cityKarlsruhe
    B.5.3.3Post code76227
    B.5.3.4CountryGermany
    B.5.4Telephone number+497243106577
    B.5.5Fax number+497243106578
    B.5.6E-mailMW029@schwabe.de
    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 Tebonin® spezial 80 mg
    D.2.1.1.2Name of the Marketing Authorisation holderDr. Willmar Schwabe GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameEGb 761
    D.3.2Product code EGb 761
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 122933-57-7
    D.3.9.2Current sponsor codeEGb 761
    D.3.9.3Other descriptive nameGINKGO LEAF DRY EXTRACT, REFINED AND QUANTIFIED
    D.3.9.4EV Substance CodeSUB47670
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 Yes
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product Yes
    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
    Presby Vertigo
    Altersschwindel
    E.1.1.1Medical condition in easily understood language
    Vertigo/Dizziness, age-related
    Altersschwindel
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10047340
    E.1.2Term Vertigo
    E.1.2System Organ Class 10013993 - Ear and labyrinth disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Tendency to falling in stance and gait conditions
    Fallneigung in Gleichgewichtssituationen
    E.2.2Secondary objectives of the trial
    - subjective impairment due to vertigo
    - hearing ability
    - cognitive capacity
    -safety and tolerability
    - Subjektive Beeinträchtigung durch Schwindel
    - Hörvermögen
    - Kognitive Leistungsfähigkeit
    - Sicherheit und Verträglichkeit
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men and women aged 60 or older
    2. subjective chronic vertigo for > 3 months
    3. Dizziness Handicap Inventory (DHI) score > 25
    4. Geriatrischen Standard Balance Defizit Test determined risk of falling > 40 %
    5. Written informed consent
    6. Willingness and ability to participate all stuy specific tasks
    1. Männer und Frauen 60 Jahre oder älter
    2. Subjektiver chronischer Schwindel seit > 3 Monaten
    3. Im Dizziness Handicap Inventory (DHI) ein Wert > 25
    4. Im geriatrischen Standard Balance Defizit Test ein Sturzrisiko > 40 %
    5. schriftliche Einwilligung nach Aufklärung
    6. Bereitschaft und Fähigkeit, an allen studienspezifischen Maßnahmen teilzunehmen.
    E.4Principal exclusion criteria
    1. hemorrhagic diatheses, coagulation disorder, Ulcus ventriculi or duodeni
    2. Diseases affecting resorption
    3. Severe or acute general diseases within the last 4 weeks
    4. Acute or chronic otologic, neurologic or psychiatric diseases within the last 12 months except age-related vertigo, i.e. depression, stroke, TIA, Parkinson-disease, Alzheimer-disease, seizure disorders, craniocerebral trauma, brain haemorrhage, Multiple sklerosis, ISSHL, morbus menière, benign positional vertigo
    5. Severe or instable internal disorders such as
    a. Malignoma with the exception of carcinoma in situ, adequately treated basal cell carcinoma or curative treated malignom more than 3 years ago
    b. uncontrolled arterial hypertension
    c. uncontrolled Diabetes mellitus
    d. Known cardiac arrhythmia (Lown-classification IVb and V)
    e. Heart failure NYHA III or IV
    f. Active bacterial infections
    g. Severe coronary heart disease (State IV Canadian Cardiovascular Society), instable angina pectoris, heart attack within the last 6 months
    6. clinically significant changes ECG- or Lab, that need treatment
    7. Hypersensitivity against one of the ingredients of the study drug
    8. Substance misuse or addiction current or in medical history
    9. Participation in other clinical trials within the last 12 weeks
    10. Concomitant medication out of one of the following substance classes
    a. anticoagulants (Heparin, Vitamin-K-Antagonist, Dabigatran, Apixaban or Rivaroxaban)
    b. Antidementics or Nootropics
    c. benzodiazepines
    11. Intake of a Ginkgo-biloba products within the last 12 weeks
    12. Planned surgery or hospitalization during study period
    13. Other factors that prevent from study participation
    14. People, who are in institutional care due to official or ancillary order
    15. People, who depend on sponsor or investigator
    1. Hämorrhagische Diathese, Gerinnungsstörung, Ulcus ventriculi oder duodeni
    2. Erkrankungen, die die Resorption beeinträchtigen können
    3. Schwere oder akute Allgemeinerkrankung innerhalb der letzten 4 Wochen
    4. Akute oder chronische otologische, neurologische oder psychiatrische Erkrankung
    innerhalb der letzten 12 Monate außer Altersschwindel, wie z. B. Depression, Schlaganfall, TIA, Parkinson-Krankheit, Alzheimer-Krankheit, Anfallsleiden, Schädel-Hirn-Trauma, Hirnblutung, Multiple Sklerose, Hörsturz, Morbus Menière, gutartiger Lagerungsschwindel
    5. Schwere oder instabile internistische Erkrankung wie z. B.
    a. Malignom mit Ausnahme von Carcinomata in situ, adequat behandeltem Basalzellkarzinom oder vor über 3 Jahren kurativ behandeltem Malignom
    b. Unkontrollierte arterielle Hypertonie
    c. Unkontrollierter Diabetes mellitus
    d. Bekannte Herzrhythmusstörungen (Lown-Klassen IVb und V)
    e. Herzinsuffizienz NYHA III oder IV
    f. Aktive bakterielle Infektion
    g. Schwere koronare Herzerkrankung (Stadium IV nach Canadian Cardiovascular Society), instabile Angina pectoris, Herzinfarkt innerhalb der letzten 6 Monate
    6. klinisch signifikante behandlungsbedürftige EKG- oder Laborveränderungen
    7. Überempfindlichkeit gegenüber einem der Inhaltsstoffe der Prüfmedikation
    8. Substanzmissbrauch oder -abhängigkeit aktuell oder in der Anamnese
    9. Teilnahme an einer anderen klinischen Prüfung in den letzten 12 Wochen
    10. Begleitmedikation aus einer der folgenden Substanzklassen
    a. Antikoagulantien (Heparin, Vitamin-K-Antagonist, Dabigatran, Apixaban oder Rivaroxaban)
    b. Antidementiva oder Nootropika
    c. Benzodiazepine
    11. Einnahme eines Ginkgo-biloba Präparats innerhalb der letzten 12 Wochen
    12. geplanter operativer Eingriff oder Krankenhausaufenthalt im Studienzeitraum
    13. Andere Faktoren, die die Teilnahme an der Studie in Frage stellen (z. B. unzureichendes Verständnis von Wesen und Tragweite der Studie, unzureichende Kenntnisse der deutschen Sprache)
    14. Personen, die auf gerichtliche oder behördliche Anordnung in einer Anstalt untergebracht sind
    15. Personen, die vom Sponsor oder Prüfer abhängig sind
    E.5 End points
    E.5.1Primary end point(s)
    Change of tendency of falling
    Veränderung des Sturzrisikos
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 6 weeks of treatment
    nach 6 Wochen Behandlung
    E.5.2Secondary end point(s)
    - Change of tendency of falling between V2 and V3 as well as V2 and V5
    - subjective restrictions due to vertigo
    - hearing ability
    - cognitive capacity
    -safety and tolerability
    - Veränderung der Fallneigung in Gleichgewichtssituationen zwischen Visite 2 und Visite 3 sowie Visite 2 und Visite 5
    - subjektive Beeinträchtigung durch Schwindel
    - Hörvermögen
    - Kognitive Leistungsfähigkeit
    - Sicherheit und Verträglichkeit
    E.5.2.1Timepoint(s) of evaluation of this end point
    - After 4 weeks of treatment with EGb761® (Visite 3)
    - After 6 weeks treatment (4 weeks only EGb761®, 2 weeks EGb761® and balance exercise) (Visite 4)
    - 6 weeks after end of balance training (12 weeks EGb761® inclusive 2 weeks balance exercise) (Visite 5).
    • Nach 4 Wochen Behandlung mit EGb761® (Visite 3)
    • Nach 6 Wochen Behandlung (4 Wochen nur EGb761®, 2 Wochen EGb761® und Gleichgewichtstraining) (Visite 4)
    • 6 Wochen nach Abschluss des Gleichgewichtstrainings (12 Wochen EGb761® einschließlich 2 Wochen Gleichgewichtstraining) (Visite 5).
    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 Yes
    E.6.5Efficacy Yes
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    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
    Medizinprodukt (VertiGuard) Therapie
    Medical device (VertiGuard) Therapy
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    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
    Last patient last visit.
    Letzte Visite letzter Patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months40
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 No
    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 state120
    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)
    The used study drug is available in German pharmacies without prescription. The VertiGuard (medical device for the performance of the balance exercise) is CE certified and is available in Germany. Patients can continue with both treatments after the study.
    In case unknown physical or psychological disorders are detected during screening the investigator will inform the patients' GP. If there is no GP, the inv will assist finding the appropriate help for the patient.
    Das verwendete Arzneimittel ist rezeptfrei in Apotheken erhältlich. Das Gleichgewichtstraining mittels VertiGuard® RT ist CE zertifiziert. Beide Therapien können zukünftig in die Therapie des Patienten integriert werden.
    Bei Verdacht auf bisher unbekannte oder unzureichend behandelte körperliche o. psych. Erkrankung , wird vom Prüfer ein Schreiben mit genauen Angaben an den Hausarzt verfasst. Kein Hausarzt, Hilfestellung und Beratung durch den Prüfer bei Findung eines geeigneten Arztes.
    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 Decision2014-09-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-06-19
    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-Tue Apr 23 18:06:43 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA