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    Summary
    EudraCT Number:2005-003747-31
    Sponsor's Protocol Code Number:523001.01.071
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-11-22
    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 ConcernedLatvia - SAM
    A.2EudraCT number2005-003747-31
    A.3Full title of the trial
    Randomised, Double-Blind, Placebo-Controlled, Parallel Group Trial to Confirm the Efficacy, Safety and Tolerability of Ginkgo biloba Special Extract EGb 761® in Patients Suffering from Mild Mental Impairment (MMI)
    A.4.1Sponsor's protocol code number523001.01.071
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 support
    B.4.2Country
    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 Information not present in EudraCT
    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® 240 mg SF, film-coated tablets
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Information not present in EudraCT
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Yes
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    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 placeboFilm-coated tablet
    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
    mild mental impairment
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Classification code 10027374
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this clinical trial is to prove the clinical efficacy, safety and tolerability of the Ginkgo biloba special extract EGb 761 in mild mental impairment (MMI). Since both cognitive impairment and associated neuropsychiatric symptoms are core features of the condition and contribute substantially to patients distress and reduced quality of life, efficacy assessment will include both cognitive function and neuropsychiatric symptoms.
    Clinical efficacy is expected to manifest itself as an increase or smaller decrease, compared with the placebo group, in the score of the WMS III subtest Faces II and/or an increase or smaller decrease in the number of completed tasks in the Wiener Test System ALS and/or in an increase or smaller decrease in the number of correct reactions in the Wiener Test System DT and/or a decrease or smaller increase in the total score of the BfS' in the patient group treated with EGb 761.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Male or female outpatients aged 45 to 65 years (both inclusive)
    2. Suffering from mild mental impairment as defined by the diagnostic criteria:
    a) subjective complaints of impairment, perceived as a decline from former level of functioning, in at least one of the following cognitive functions: memory, attention/concentration, speed of functioning, efforts required to complete complex tasks, general performance/efficiency
    b) low functioning (at least one standard deviation worse than the mean of the most appropriate normative group) in at least one of the cognitive tests administered at screening and baseline
    c) perceived impairment present for at least 3 months
    d) widely preserved general cognitive function, as evidenced by a total score above 23 in the MMSE
    e) intact activities of daily living, as evidenced by inquiry (subtle difficulties, in particular slowing or increased efforts, in complex tasks is acceptable)
    f) no indication of dementia
    3. Written informed consent according to applicable law
    4.Sufficient Latvian language skills to understand and respond to all interview questions and undergo neuropsychological testing without evident difficulties and without the assistance of an interpreter.







    E.4Principal exclusion criteria
    1. Participation in another experimental drug trial at the same time or within the past 4 weeks before enrolment
    2. Prior participation in a clinical trial with Ginkgo biloba within the last 3 months
    3. Hospitalization of the patient
    4. Ischemic stroke with sequelae within the last 3 months
    5. Cognitive impairment due to systemic or cerebral infection, somatic disorders, neurological disorders (e.g. dementia of any type, alcohol-associated brain damage, HIV-associated cognitive disorder, Parkinson’s disease, Huntington’s disease, Pick’s disease, Wilson’s disease, normal pressure hydrocephalus, progressive supranuclear palsy, Creutzfeldt-Jakob disease, brain tumour, subdural haematoma, multiple sclerosis, seizure disorder, brain trauma, etc) or psychiatric disorder (e.g. affective or anxiety disorder on a syndromal level), including clinical suspicion of any of the above.
    6. History of recurrent major depression or recurrent anxiety disorder. If a single episode of such a disorder was present before, it must have been finished at least one year before enrolment.
    7. History of head trauma that might be causally related to cognitive impairment because of:
    - its clinical severity or
    - trauma-related lesions in CT or
    - temporal relationship to the onset of cognitive dysfunction or
    - repeated minor head trauma
    8. Any use of antidementia drugs, nootropics, cognition enhancing drugs, CNS stimulants, cholinergic and anticholinergic drugs unless there is an at least 8-week washout before entering the randomized treatment period (for details see Section 6)
    9. Any continued use of psychoactive drugs, such as antidepressants, neuroleptics, tranquilizers, sedatives, hypnotics, sedating anti-histamine agents, sedating analgesic drugs.
    Occasional use (up to three times a week) of tranquilizers for sleep disturbances is permissible, but not within 48 hours prior to test sessions (for details see Section 6)
    10. Any use of haemorrheologic drugs, anti-epileptics and anti Parkinson drugs unless there is a washout of at least 8 weeks before entering the randomized treatment period (for details see Section 6)
    11. Substance addiction or abuse within the last 5 years
    12. Severe, uncontrolled cardiovascular disease, especially:
    -severe (stage IV acc. to Canadian Cardiovascular Society) or unstable angina pectoris
    - decompensated congestive heart failure (NYHA stage IV)
    - myocardial infarction within the last 6 months
    - uncontrolled hypertension (systolic pressure > 180mmHg, diastolic pressure > 115mmHg)
    -known clinically significant cardiac arrhythmias (Lown classes IVb and V)
    13.Severe renal or hepatic dysfunction (serum creatinine or serum ASAT, ALAT or Gamma-GT above 3 times the upper limit of the reference range)
    14. Insufficiently controlled insulin-dependent diabetes mellitus
    15. Clinically significant anaemia
    16. Known clinically significant thyroid dysfunction
    17. Known HIV infection or Lues of any stage (according to medical history or clinical signs and symptoms)
    18. Active malignant disease (Exception: prostate cancer T1N0M0 which does not require treatment within the next 7 months except hormone therapy)
    19. Known hypersensitivity to Ginkgo biloba extract

    20. Severe and insufficiently corrected loss of vision or hearing, severe language difficulties or any other disability that may prevent the patient from co-operating adequately in the trial or that may interfere with neuropsychological test performance
    21. 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)
    22. Any circumstances that do not allow the patient to be followed up at the scheduled intervals
    23. Female patients of childbearing potential
    (At least one of the following criteria must be fulfilled to render childbearing sufficiently unlikely: a) treatment with hormone contraceptives for at least 6 months, b) postmenopausal state for at least 2 years, c) hysterectomy, d) bilateral tubal ligation, or e) bilateral oophorectomy)
    E.5 End points
    E.5.1Primary end point(s)
    The primary aim of the study is to confirm the efficacy of EGb 761 in patients suffering from Mild Mental Impairment (MMI). In confirmatory analysis, this will be done by assessing the following three parameters as primary efficacy parameters:
    • change of the raw score of the Wechsler Memory Scale III (WMS III) – Faces II between baseline and week 12 (week 12 – baseline)
    • change of the number of correct reactions measured by the Wiener Test system Determination test (DT) between baseline and week 12 (week 12 – baseline)
    • change of the total score of the Mental Balance Scale (Befindlichkeitsskala, BfS’) between baseline and week 12 (baseline – week 12; high values should indicate an improvement of mental balance, hence, the difference has to be changed)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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.8.3 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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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 years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    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 No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 300
    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)
    There are currently no guidelines for symptomatic treatment of non-demented patients with mild cognitive and affective problems. If further treatment is advisable, there are different drugs with marketing authorisation available for this condition.
    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 Decision2005-12-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-11-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-02-14
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