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    The EU Clinical Trials Register currently displays   39188   clinical trials with a EudraCT protocol, of which   6421   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2016-000316-15
    Sponsor's Protocol Code Number:523079.01.114
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-07-20
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2016-000316-15
    A.3Full title of the trial
    Clinical Trial to Explore Treatment Effects of Ginkgo biloba Extract EGb 761® in Patients with Different Types of Vertigo and Effect Modification by Type of Vertigo, Chronicity and Concomitant Pathologies
    Badanie kliniczne skuteczności leczenia wyciągiem z miłorzębu japońskiego EGb 761® u pacjentów z różnymi typami zawrotów głowy, a także zmiany tej skuteczności w zależności od typu i przewlekłości zawrotów głowy oraz zaburzeń współtowarzyszących.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Trial to Explore Treatment Effects of Ginkgo biloba Extract EGb 761® in Patients with Different Types of Vertigo and Effect Modification by Type of Vertigo, Chronicity and Concomitant Pathologies
    Badanie kliniczne skuteczności leczenia wyciągiem z miłorzębu japońskiego EGb 761® u pacjentów z różnymi typami zawrotów głowy, a także zmiany tej skuteczności w zależności od typu i przewlekłości zawrotów głowy oraz zaburzeń współtowarzyszących.
    A.4.1Sponsor's protocol code number523079.01.114
    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 pointProject Director
    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 number00497214005632
    B.5.5Fax number004972140058632632
    B.5.6E-mailAnnette.Wassmer@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 ® intens 120 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.3.4Pharmaceutical 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.3.8INN - Proposed INNGinkgo biloba special extract EGb 761®
    D.3.9.3Other descriptive nameDry extract from Ginkgo biloba leaves (35-67:1) 120 mg; extraction agent: acetone 60% (w/w)
    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 number120
    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
    Different types of vertigo
    Różne rodzaje zawrotów głowy
    E.1.1.1Medical condition in easily understood language
    Different types of vertigo
    Różne rodzaje zawrotów głowy
    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
    • To explore whether causes, risk factors, chronicity of vertigo and accompanying features influence the treatment effect of EGb 761® in terms of improvement and response rates
    • To identify groups of patients that benefit most of EGb 761®
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria
    1. Outpatients of both sexes, at least 18 years old.
    2. Vertigo syndrome
    a. diagnosed and specified by medical history and physical examination, Rombergtest, Unterberger stepping test, nystagmus testing with (alternatively by VNG) andwithout Frenzel glasses, and the following diagnostic tests which may have beenperformed up to 3 months before Baseline Visit: ENG or VNG including caloric testing, vHIT, VEMPs, Dix-Hallpike test (only to be performed if necessary to exclude BPPV), ECG;
    b. excluding BPPV, Ménière's disease, vestibular migraine, somatoform phobic
    vertigo, acute vestibular neuritis within the first two weeks of onset, acute central or peripheral vertigo within the first two weeks of onset;
    c. duration of at least 2 weeks.
    3. Score > 25 in the Dizziness Handicap Inventory.
    4. Written informed consent to participate in the clinical trial, to trial-related treatment and to data recording in accordance with applicable laws.
    Note: The gaze test and positional test may alternatively be performed with Frenzelglasses instead of ENG / VNG.
    E.4Principal exclusion criteria
    1. Participation in another experimental drug trial at the same time or within the past 4 weeks before Baseline Visit.
    2. Vertigo for which other treatments are recommended by current guidelines or expert consensus: BPPV, Ménière's disease, vestibular migraine, somatoform phobic vertigo, acute vestibular neuritis within the first two weeks of onset, acute central or peripheral vertigo within the first two weeks of onset.
    3. Any other drug treatments for vertigo taken currently or within 2 weeks before Baseline Visit.
    4. Gingko biloba preparation for any reason taken currently or within 4 weeks before Baseline Visit.
    5. Ongoing psychiatric disorder, such as major depression, generalized anxiety disorder, schizophrenia, etc.
    Of note: Symptoms of depression or anxiety or other behavioral or psychological symptoms at sub-syndromal level and not requiring treatment with psychotropic drugs are permitted.
    6. Ongoing severe cardiac or circulatory disorder
    a. severe (Canadian Cardiovascular Society stage IV) or unstable angina pectoris
    b. decompensated congestive heart failure (NYHA stage IV)
    c. uncontrolled hypertension with systolic blood pressure above 180 mmHg and/or diastolic blood pressure above 115 mmHg
    d. clinically significant cardiac arrhythmias (Lown classes IVb and V, bifascicular bundle branch block).
    7. Severe renal or hepatic dysfunction (defined by serum creatinine or serum ASAT, ALAT or gamma-GT above 3 times the upper limit of the reference range in the anamnesis).
    8. Ongoing uncontrolled endocrine or hematological disorder.
    9. Intake of drugs not permitted during participation in the trial, in particular, psychoactive drugs, systemic acting perfusion-enhancing drugs, cognition enhancing drugs, systemic acting anti-cholinergic drugs, regular use of anticoagulants (platelet aggregation inhibitors permitted) during the 2 weeks prior to Baseline Visit.
    10. Ongoing hemorrhagic diathesis or coagulation disorder.
    11. Seizure within 2 years prior to Baseline Visit or regular use anticonvulsive drugs.
    12. Active malignant disease (exception: prostate cancer which does not require other than hormone treatment within the next 6 months).
    13. Known hypersensitivity to Ginkgo biloba extract or to excipients contained in the tablets.
    14. Active peptic ulcer disease or any gastrointestinal disease with potential impairment of the absorption of orally applied drugs (e.g. Billroth I/II, Crohn's disease, ulcerative colitis, any kind of enterectomy).
    15. Female patients of childbearing potential without safe contraception (any form of hormonal contraception, intrauterine devices, sexual abstinence and partner sterilization are considered sufficiently safe when used consistently and correctly; child-bearing potential can be denied in case of postmenopausal state for at least 2 years, hysterectomy, bilateral tubal ligation or bilateral oophorectomy).
    16. Planned surgical intervention requiring hospitalization during the clinical trial.
    17. Previous inclusion in the present clinical trial.
    18. Incapability of understanding nature, meaning and consequences of the clinical trial.
    19. Patient unable to read and / or write.
    20. Patients in custody by juridical or official order.
    21. Patients, who are members of the staff of the trial center, staff of the sponsor or involved Clinical Research Organizations (CROs), the investigator him- / herself or close relatives of the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    Effectiveness:
    • Vertigo Symptom Scale – Short Form (VSS-SF, Yardley et al. 1992, 2004)
    • 11-point box scale for severity of vertigo
    • Dizziness Handicap Inventory (DHI, Jacobson & Newman 1990)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 6 Visit and Week 12 Visit.

    All analyses will be done at the end of the trial.
    E.5.2Secondary end point(s)
    Safety:
    • Serious adverse events (SAEs) and non-serious adverse events
    • Vital signs
    • Safety laboratory results
    E.5.2.1Timepoint(s) of evaluation of this end point
    Serious adverse events (SAEs) and non-serious adverse events throughout the whole trial.
    Vital signs and safety laboratory results at Screening Visit and Week 12 Visit.

    All analyses will be done at the end of the trial.
    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 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
    to explore whether causes, risk factors, chronicity of vertigo and accompanying features influence the treatment effect of EGb 761®
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    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 concerned12
    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
    Data base lock
    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 months9
    E.8.9.1In the Member State concerned 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: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 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 state175
    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)
    After the study has ended the participation in the trial the subject will be receiving the standard therapy according to the clinical practice in Poland.
    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 Decision2016-09-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-06-12
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