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    Summary
    EudraCT Number:2005-005765-11
    Sponsor's Protocol Code Number:523001.01.078
    National Competent Authority:Estonia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-03-14
    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 ConcernedEstonia - SAM
    A.2EudraCT number2005-005765-11
    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.3.2Name or abbreviated title of the trial where available
    NA
    A.4.1Sponsor's protocol code number523001.01.078
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNA
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNExtractum siccum Ginkgo biloba
    D.3.9.2Current sponsor codeEGb 761
    D.3.9.3Other descriptive nameDry extract from Ginkgo biloba leaves (35-67:1), extraction solvent: acetone 60% (w/w)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number240
    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) 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 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 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
    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.1.3Condition 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 complaints of cognitive decline and associated neuropsychiatric symptoms are core features of the condition and contribute substantially to patients' distress and impaired quality of life, efficacy assessment will include both perceived cognitive function and neuropsychiatric symptoms.
    Clinical efficacy is expected to manifest itself as an improvement, compared with the placebo group, in the perceived cognitive impairment and/or in the neuropsychiatric symptoms in the patient group tested 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
    Patients are eligible for inclusion in this study, if they fulfil all of the following 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 outlined under section 8.7 in clinical trial protocol:
    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) presence of at least one of the following neuropsychiatric symptoms: depressed mood/dysphoria, anxiety, irritability/lability, apathy/indifference, fatigue, decreased general wellbeing
    c) perceived impairment present for at least 3 months
    d) widely preserved general cognitive functioning, 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 estonian 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
    Patients with any of the following characteristics must not be included in the study:

    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. Ischaemic 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. D-S’ item score for item 11 (suicidal ideation) > 0

    8. 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

    9. 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 randomised treatment period (for details see Section 6 in clinical trial protocol)

    10. 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 in clinical trial protocol)

    11. Any use of haemorrheologic drugs, anti-epileptics and anti Parkinson drugs unless there is a washout of at least 8 weeks before entering the randomised treatment period (for details see Section 6 in clinical trial protocol)

    12. Substance addiction or abuse within the last 5 years

    13. 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)

    14. Severe renal or hepatic dysfunction (serum creatinine or serum ASAT, ALAT or Gamma-GT above 3 times the upper limit of the reference range)

    15. Insufficiently controlled insulin-dependent diabetes mellitus

    16. Clinically significant anaemia

    17. Known clinically significant thyroid dysfunction

    18. Known HIV infection or Lues of any stage (according to medical history or clinical signs and symptoms)

    19. Active malignant disease (Exception: prostate cancer T1N0M0 which does not require treatment within the next 7 months except hormone therapy)

    20. Known hypersensitivity to Ginkgo biloba extract

    21. 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 neuropsychologic test performance

    22. 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)

    23. Any circumstances that do not allow the patient to be followed up at the scheduled intervals

    24. Female patients of childbearing potential
    (At least one of the following criteria must be fulfilled to render childbearing sufficiently unlikely: a) treatment with oral contraceptives for at least 6 months, b) postmenopausal state for at least 2 years, c) hysterectomy, d) bilateral tubal ligation, or e) bilateral oophorectomy)

    25. Pregnant and nursing women
    E.5 End points
    E.5.1Primary end point(s)
    Cognitive Domain:
    Perceived changes in the following two of five assessed capabilities of the cognitive domain, self-assessed at week 12 by the patient on a 7-point scale using the "Questionnaire of cognitive functions":
    - memory
    - attention / concentration

    Neuropsychiatric Domain:
    Perceived changes in the following two of six assessed conditions of the neuropsychiatric domain, self-assessed at week 12 by the patient on a 7-point scale using the "Questionnaire of neuropsychiatric symptoms":
    - depressed mood / dysphoria
    - anxiety
    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 No
    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 Information not present in EudraCT
    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) Yes
    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 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 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 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
    Provided in the protocol
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-03-14. Yes
    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 state300
    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 mental impairment. Usually, this condition is not considered an illness and would not necessarily require pharmacotherapy. For more serious types of cognitive dysfunction, a number of licensed medicinal preparations are available, e.g. nootropic agents and cholinesterase inhibitors. Non-medicinal procedures, such as memory training, can also be beneficial.
    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 Decision2006-04-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-02-27
    P. End of Trial
    P.End of Trial StatusCompleted
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