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    Summary
    EudraCT Number:2005-004215-30
    Sponsor's Protocol Code Number:BRD/05/155
    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:2006-01-30
    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 number2005-004215-30
    A.3Full title of the trial
    Imaging the neural correlates of cholinergic and behaviour driven rehabilitation in patients with Wernicke’s aphasia: a double-blinded, cross-over, randomised controlled trial.
    A.3.2Name or abbreviated title of the trial where available
    Imaging the neural correlates of rehabilitation in Wernicke’s aphasia.
    A.4.1Sponsor's protocol code numberBRD/05/155
    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 SponsorJoint Sponsorship: University College London (UCL) & University College London Hospitals (UCLH)
    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 Aricept 5mg
    D.2.1.1.2Name of the Marketing Authorisation holderEisai Ltd
    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 namePR1
    D.3.2Product code PR1
    D.3.4Pharmaceutical form 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.IMP: 2
    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 Aricept 5mg (x2 tabs to give 10mg)
    D.2.1.1.2Name of the Marketing Authorisation holderEisai Ltd
    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 namePR2
    D.3.2Product code PR2
    D.3.4Pharmaceutical form 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 placeboCapsule, soft
    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
    Wernicke's aphasia caused by a stroke
    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
    Currently there is little good evidence to guide treatment of patients with post-stroke aphasia. Aphasia research has also been hampered by the lack of a good physiological measure of language function.

    The proposal is that, in a group of patients with post-stroke aphasia, mismatch negativity (MMN) signals produced the brain in response to specific auditory stimuli will act as a biological marker of improving auditory perception. The plan is to measure these responses over time in a group of suitable patients with a “Wernicke-type” aphasia to identify brain regions that support improving function driven by two types of therapy: Cholinergic drug therapy (using donepezil hydrochloride), and phonological training. Changes in the MMN signal will form the first main outcome measure; the second is language function and will be assessed using a battery of language tests.
    E.2.2Secondary objectives of the trial
    This study is designed to investigate three main hypotheses:

    Hypothesis 1: Main effects of stroke revealed by MEG, fMRI and psychophysical measures. Patients’ self-reported perceptual responses to parametrically modulated speech stimuli will be preferentially affected compared to their responses to parametrically modulated acoustically- matched non-speech stimuli. The neural correlates of this effect will be examined by measuring patients’ MMN responses to speech and non-speech stimuli, and by comparing this to data from normal age-matched controls.

    Hypothesis 2: Main effect of treatment in patients (MMN responses).
    The treatment effects of drug and behavioural therapy will correlate with changes in the location, emergence, amplitude or duration of the MMN responses.

    Hypothesis 3: Main effect of treatment in patients (behavioural responses).
    The treatment effects of drug and behavioural therapy will correlate with improvements in tests of language function.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    60 Patients with a Wernicke-type aphasia caused by a stroke will be recruited, that is: those with either a deficit in auditory processing of normal speech, or with a speech error pattern consistent with this syndrome (high-output, paraphasic or jargon aphasia), or both. It is likely that these patients will have sustained damage to the dominant temporal lobe or its connections as judged by CT/MRI scans. Subjects will be English native speakers; those with significant medical or psychiatric co-morbidity will be excluded, as will those with an absolute contraindication to either donepezil or MRI scanning. Patients will be in the post-acute phase (>3 month post stroke), but those with a chronic deficit may also be included as these patients can benefit from even quite late intervention. These subjects will be studied longitudinally over 7 time points, to assess the effects of the two therapeutic interventions.

    Patients with Wernicke-type aphasia will be recruited. That is, those with either a deficit in auditory processing of normal speech, or with a speech error pattern consistent with this syndrome (high-output, paraphasic or jargon aphasia), or both. The language deficit will have to be of a sufficient severity for the patients or their carers to complain of communication problems. Other criteria (and associated justifications):
    • Subjects will be English native speakers.
    • Subjects will be over the age of 18.
    • Patients will not be entered into the treatment part of the trial until three months or more has elapsed after their aphasic stroke (to allow for acute changes in cerebral auto-regulation to normalize and for early ‘spontaneous’ recovery of language function to have largely occurred. See Appendix 2 for graphs depicting rates of recovery over time).
    • There will be no upper limit of time since aphasic stroke (patients with a chronic deficit can benefit from even quite late intervention).
    • Only consent competent patients will be enrolled.

    30 normal, aged-matched volunteers will also be recruited. These subjects will be right-handed, English native speakers. Those with significant medical or psychiatric co-morbidity will be excluded, as will those with an absolute contraindication to MRI scanning. Control subjects will be tested in the same manner as patients but only studied once and not exposed to either therapy.
    E.4Principal exclusion criteria
    Patients:
    • Significant medical or psychiatric co-morbidity (unable to comply with: either the treatment regime, including the computer-based BT; or scanning (lying flat for up to 1.5 hours at a time)).
    • Clinical or neuroimaging evidence of significant multifocal cerebral disease (it will be difficult to interpret functional neuroimaging data).
    • Patients with contraindications to cholinesterase inhibitors (sick sinus syndrome, pregnancy).
    • Patients with contraindications to fMRI/MEG (pacemaker, non-compatible metallic implant, etc (see FIL scanning checklist for other absolute and relative contraindications)).
    • Severe hearing impairment (this will be checked using an audiometer).
    • Less than 18 years old.
    • Patient unable to provide informed consent (see written and pictorial information sheets for patients and their carers)

    Normal subjects:
    • Significant medical or psychiatric co-morbidity.
    • Contraindications to fMRI/MEG (pacemaker, non-compatible metallic implant, etc (see FIL scanning checklist for other absolute and relative contraindications)).
    • Severe hearing impairment.
    • Less than 18 years old (this population needs to be age-matched to the patient group).
    E.5 End points
    E.5.1Primary end point(s)
    1. Correlation between treatment type and improvements on conventional language rating scales acquired in face-to-face interviews with patients. Primary outcome measure, the language modality mean score from the Comprehensive Aphasia Test (CAT). This is a transformed T score with good: test-retest stability, inter-rater reliability and predictive validity.
    2. Correlation between treatment type and changes in the response characteristics of a neurophysiologic measure of auditory discrimination (MMN), provoked by language and non-language stimuli, measured using both MEG and fMRI. This will be measured in terms of relative differences in the emergence and amplitude of the MMN responses within individuals by using treatment type as a covariate of interest. These comparisons will be made using Statistical Parametric Mapping (SPM) software SPM5.
    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 No
    E.6.5Efficacy No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.6Cross over Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    The end of the trial occurs when the last patient (of a proposed 60 maximum) completes the last scanning session of the trial (which occurs after they have had their final dose of drug/placebo, see protocol for more details). However, a final testing session (language and acoustic tests only) is planned at three months post completion of the project to investigate whether any therapy driven improvements in language function persist.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    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 2006-01-30. 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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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)
    See protocol
    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 Decision2006-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-01-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-01-14
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