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    The EU Clinical Trials Register currently displays   35554   clinical trials with a EudraCT protocol, of which   5841   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2005-000381-39
    Sponsor's Protocol Code Number:KCL/DS/MEM/1
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-07-25
    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 ConcernedUK - MHRA
    A.2EudraCT number2005-000381-39
    A.3Full title of the trial
    Efficacy and Safety of Memantine Hydrochloride, a low affinity antagonist to N-Methyl-D-Aspartate (NMDA) type receptors, in the prevention of cognitive decline and disease progression in older people with Down’s syndrome, with and without dementia
    A.3.2Name or abbreviated title of the trial where available
    Memantine in people with Down's syndrome
    A.4.1Sponsor's protocol code numberKCL/DS/MEM/1
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN47562898
    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 SponsorKing's College London
    B.1.3.4CountryUnited Kingdom
    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 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.2.1.1.1Trade name Ebixa
    D.2.1.1.2Name of the Marketing Authorisation holderH.Lundbeck A/S Ottiliavej 9, DK-2500 Valvy Denmark
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameMemantine hydrochloride
    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 Yes
    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 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 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
    Cognitive decline and dementia in Down's syndrome
    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
    Clinical:

    • To determine the clinical efficacy of Memantine versus placebo in preventing cognitive decline in people with Down's syndrome (DS).

    • To compare the safety and tolerability of Memantine versus placebo in people with DS.

    Biochemical and pathological:

    • To examine the ability of Memantine to alter markers of disease progression in DS patients.
    E.2.2Secondary objectives of the trial
    Clinical:

    • To determine whether Memantine has, as compared with placebo, a significant positive impact on:

    - level of independent functioning as measured by the carer-rated adaptive behavioural scale, (ABS) in adults with DS;
    - quality of life in adults with DS as measured by the Quality of Life questionnaire for Alzheimer's disease.


    Biochemical and pathological:

    • To investigate putative markers of Memantine’s mechanism of action in peripheral blood samples from living patients with DS.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Inclusion criteria will be:

    1. Participants with learning disabilities due to Down’s syndrome (DS) confirmed by karyotype. A clinical diagnosis (provided by the participant’s General Practitioner or hospital Specialist) will be accepted if karyotype is not known and participant does not agree to have it tested,
    2. age >40 years or any age if a diagnoses of dementia is established,
    3. in participants with dementia, the diagnosis will be consistent with the 10th version of the International Classification of Diseases (ICD-10) (WHO, 1992) diagnostic criteria.
    4. level of speech and comprehension of verbal commands are sufficient to understand and to answer simple requests,
    5. resident in care facility or community living with a carer who is willing to accept responsibility for supervising the treatment and provide input to efficacy parameters in accordance to protocol requirements,
    6. not receiving treatment with Memantine or in past 4 weeks and responsible clinician not considering treatment with Memantine,
    7. participant willing to take part in study and carer with capacity willing to assent to study and in agreement for participant to take part if participant is also willing


    E.4Principal exclusion criteria
    Exclusion criteria will be:

    1. Participants known to have sensitivity to memantine,
    2. severe, unstable or uncontrolled medical or psychiatric conditions apparent from history, physical examination or investigations,
    3. a current diagnosis of primary neurodegenerative disorders other than dementia such as Parkinson’s disease, Huntington’s disease, etc,
    4. uncontrolled epilepsy
    5. presence of challenging behaviour likely to preclude the participation during testing,
    6. presence of severe motor or sensory impairment (severe deafness or blindness) that rendered the participant as untestable with the battery of tests used in the study,
    7. current evidence of delirium,
    8. severe renal impairment
    9. low probability of treatment compliance
    10. previous evidence of lack of efficacy or tolerability to Memantine
    11. taking any of the following substances:
    • an investigational drug during the 4 weeks prior to randomization
    • a drug known to cause major organ system toxicity during the 4 weeks prior to randomization,
    • started any new psychotropic during the 4 weeks prior to randomization,
    • participants who had been on a stable dose of psychotropic during the 4 weeks prior to randomization are still eligible,
    • Memantine during the 6 weeks prior to randomization,
    • medication for Parkinson’s disease during randomization (dopamine agonists, selegiline)
    • other N-methyl-D-aspartate (NMDA) antagonists: amantadine, ketamine, and dextromethorphan
    • barbiturates and primidone
    • baclofen and dantrolen
    • dextrmethorphan
    • antimuscarinics
    E.5 End points
    E.5.1Primary end point(s)
    Comparing Memantine to placebo:
    Changes in performance from baseline on a neuropsychological battery of tests for people with DS focussing upon 3 cognitive areas: attention, memory and executive function (the DAME, battery) .

    Changes in performance from baseline on an informant based questionnaire on level of independent functioning for every day tasks, the Adaptive Behavioural Scale (ABS).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    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 Yes
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Information not present in EudraCT
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Information not present in EudraCT
    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
    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
    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) Yes
    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 2005-07-25. 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    All participants in the study will have Down's syndrome with and without dementia. Some of the participants will be incapable of given consent either due to the degree of their learning disabilities , dementia, or a combination of both.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state180
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 180
    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)
    Memantine is licensed for the treatment of people with Alzheimer's disease. Therefore if any of the participants show a good response to treatment, this will be communicated to their responsible consultant with a view to assessing whether continuing the treatment is clinically indicated.

    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 Decision2005-08-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-06-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-02-09
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