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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2005-005915-13
    Sponsor's Protocol Code Number:TRx-014-002
    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:2006-04-10
    Trial 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 number2005-005915-13
    A.3Full title of the trial
    An Open Pilot Study of Methlythioninium Chloride (MTC) in Frontotemporal Dementia and Related Dementia Syndromes
    A.3.2Name or abbreviated title of the trial where available
    Pilot Stidy of MTC in FTD and related dementia syndromes
    A.4.1Sponsor's protocol code numberTRx-014-002
    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 SponsorTauRx Therapeutics PTE Ltd
    B.1.3.4CountryUnited Kingdom
    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 nameMethylthioninium chloride
    D.3.2Product code MTC TRx0014-001 capsules
    D.3.4Pharmaceutical form Capsule, hard
    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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Information not present in EudraCT
    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
    Frontotemporal Dementia and related syndromes

    Prevention and reversal of tau protein aggregation is a novel approach to the treatment of patients with FTD and related syndromes and has the potential for slowing the disease process as well as providing symptomatic improvement in hitherto untreatable, ultimately fatal conditions.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level PT
    E.1.2Classification code 10012267
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to investigate and compare the effects of oral MTC at a dose of 100 mg tid on cognitive ability in patients with frontotemporal dementia with Parkinsonism linked to chromosome 17, frontotemporal dementia (lacking evidence of dominant inheritance), progressive aphasia (semantic dementia and progressive non-fluent aphasia), and corticobasal degeneration or progressive supranuclear palsy associated with dementia.

    Cognitive ability will be measured by the Cambridge Cognitive Examination (CAMCOG). Interim evaluations will be made at 12 weeks (visit 2), 24 weeks (visit 4), and the final evaluation will be made at 48 weeks (Visit 6).
    E.2.2Secondary objectives of the trial
    1. The secondary objectives of this study are to investigate the effects of MTC on:

    (i) Behavioural and psychological symptoms assessed on the Neuropsychiatric Inventory (NPI).
    (ii) Global state assessed on a clinical global impression / of change (CGI/C).
    (iii) Functional ability assessed on the Bristol Activities of Daily Living Scale (BADLS).
    (iv) Extrapyramidal symptoms and signs assessed on the Short Parkinson’s Evaluation Scale (SPES).

    2. Cerebral perfusion assessed by hexamethylpropylamine oxime single photon emission computerised tomography (HMPAO SPECT) scan.

    3. Cerebral atrophy assessed by MRI.

    4. The safety and tolerability of MTC will also be evaluated.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Patients of either sex supervised by a carer competent and willing to ensure compliance with medication and who is willing to participate in completing the various assessments.

    2. Female patients should not be pregnant at the start of the study or planning a pregnancy during the course of the study.

    3. Patients must be able to either give written informed consent to participation in the study, with additional assent to their participation being provided by a competent carer.

    4. Patients must meet either:

    • Consensus Clinical Diagnostic Criteria for Frontotemporal Lobar Degeneration (Neary et al 1998) including MRI and HMPAO SPECT imaging consistent with the diagnosis
    • NINDS –SPSP Clinical Criteria for Diagnosis of Probable Progressive Supranuclear Palsy including MRI and HMPAO SPECT imaging consistent with that diagnosis (Litvan et al 1996a)
    • Diagnostic Criteria for Corticobasal Degeneration including MRI and HMPAO SPECT consistent with the diagnosis (Boeve et al 2003)

    In addition to meeting the above criteria patients additionally must have significant cognitive impairment with a CAMCOG score of < 85.
    E.4Principal exclusion criteria
    The patient is not eligible to participate in the study in any of the following circumstances:

    1. The patient has a known sensitivity to MTC or similar agents.

    2. The patient has known glucose-6-phosphate dehydrogenase deficiency.
    3. The patient has known hereditary methaemoglobinaemia, has been known to have suffered an attack of acquired methaemoglobinaemia or has a blood level of methaemoglobin at screening which is above the upper limit of normal for age and laboratory.

    4. The patient has significant impairment of renal, hepatic or haematological function for the age of the patient.

    5. The patient has started taking prescribed medication known to have an effect on mood, cognition or motor function within the previous six weeks or has changed the dose of such medication within the same period (e.g.cholinesterase inhibitors, memantine, anticholinergics, hypnotics, sedatives, anxiolytics, neuroleptics antidepressants, antiepileptics or antiparkinsonian drugs).

    6. The patient has started taking an alternative anti dementia therapy (e.g. ginkgo biloba or HRT) within six weeks or has changed their dose within that period.

    7. The patient is receiving warfarin or digitalis or any other medication that has a narrow margin between effective dose and toxic dose or between effective dose and ineffective dose, where the subject would be at risk if the levels were to rise or fall due to interaction with MTC.

    8. Patients who are unlikely to comply with the study procedures or with study medication.

    9. Patients with significant intercurrent illness which in the opinion of the investigator may compromise either the safety of the patient or the validity of the data.

    10. Females who, in the opinion of the investigator, have the potential of childbearing and are not using adequate contraception or females who are breastfeeding.

    11. Patients with a history of alcohol or drug abuse defined as meeting DSM-IV criteria for substance dependence. This applies to alcohol and /or any illicit drug including cannabis within the last six months.

    12. The patient has participated in a clinical investigation of a medication or device within the previous three months.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of the study is to investigate and compare the effects of 100 mg tid oral MTC on cognitive ability in patients with FTD or related dementias.
    Change in cognitive ability from baseline to week 48 will be measured by the Cambridge Cognitive Examination (CAMCOG).

    Secondary objectives of the study are to investigate the bahavioural and pschological symtoms assessed on the NPI, clobal sate assessed on the CGI/C, functional ability assessed on the BADLS, extrapyramidal symptoms and signs assessed on the SPES, cererebral perfusion assessed by SPECT.
    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 Yes
    E.6.7Pharmacodynamic Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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.8.5The 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
    See protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months18
    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) 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 2006-04-10. 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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    adults with dementia
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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 Decision2006-05-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-07-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-07-24
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