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    Summary
    EudraCT Number:2007-002470-59
    Sponsor's Protocol Code Number:TRx-014-009
    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:2007-06-26
    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 number2007-002470-59
    A.3Full title of the trial
    AN OPEN LABEL CONTINUATION STUDY OF THE EFFECTS OF MTC 30 MG TID AND 60 MG TID IN PATIENTS WITH ALZHEIMER’S DISEASE
    A.3.2Name or abbreviated title of the trial where available
    Open Label Study of Methylthioninium Chloride (MTC) in Alzheimer’s Disease
    A.4.1Sponsor's protocol code numberTRx-014-009
    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 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 No
    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 capsules
    D.3.2Product code TRx0014
    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.3.8INN - Proposed INNMETHYLTHIONINIUM CHLORIDE
    D.3.9.1CAS number 61734
    D.3.9.2Current sponsor codeTRx0014
    D.3.9.3Other descriptive nameMethylene Blue
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30 to 60
    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 No
    D.3.11.8Extractive medicinal product No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    An estimated 685,000 people in the UK suffer from dementia, with Alzheimer’s disease (AD) being the most common cause affecting over 400,000 people (Alzheimers Society 2007). It is a devastating illness which causes a progressive decline in mental ability and functional capacity and causes immense distress to patients, their carers and families and has an enormous societal impact.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level PT
    E.1.2Classification code 10012271
    E.1.2Term Dementia Alzheimer's type
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objectives of the study are to investigate the long term safety, tolerability and efficacy of oral TRx0014 at two doses (30 and 60 mg tid) in patients with AD.

    The long term safety and tolerability will be determined by frequent follow up, assessment of adverse events and measurement of haematological and biochemistry parameters.

    The long term efficacy will be determined by the continued assessment of:

    1. cognitive ability measured by the Alzheimer’s Disease Assessment Scale - cognitive subscale (ADAS-cog) and by the Mini-Mental State Examination (MMSE).
    2. dementia severity assessed by the Clinical Dementia Rating – sum of the boxes (CDR-sb).
    3. daily living activities assessed by the Alzheimer’s Disease functional Assessment and Change Scale (ADFACS)
    4. Short CAMDEX - dementia caseness based on cut off scores on the cognitive and organicity sub-scales
    5. Behavioural and psychological symptoms assessed by the Neuropsychiatric Inventory (NPI).
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title of Study: Partial validation of an Assay to Determine the Concentration of MTC in Human Blood and Human Urine

    Date: 25 January 2008

    Version: 1

    Objectives: To support development and partial validation of appropriate bioanalytical methods to measure MTC in blood and urine to elucidate its Pharmacokinetic (PK) profile in man.

    Trial Requirements and Duration: A single blood and urine sample is required from each of six subjects currently dosing with oral MTC. It is anticipated that these will be collected from subjects at a routine TRx-014-009 visit where venepuncture is already being carried out.

    Selection Criteria: Subjects must have capacity to consent, be participating in trial TRx-014-009, and have been taking the prescribed treatment regimen (tid dosing) for at least the 5 days prior to the day on which samples are collected.

    Procedure: Patients currently in trial TRx-014-009 under the care of Dr D Mowat at Aberdeen will be contacted prior to their next study visit by telephone to ask if they might be interested in participating in this sub-study. Patients and carers that are interested to find out more will be sent a patient information leaflet specifically about the sub-study. The information leaflet is attached to Appendix 14 in the amended clinical trial protocol (protocol amendment 1).
    Patients will be free to take part in the sub-study or to decline without it affecting their participation in TRx-014-009.
    Patients interested in taking part in the sub-study will have the opportunity to discuss the sub-study prior to the next visit and at the visit and those agreeing to take part will provide written informed consent prior to undergoing the sub-study procedures.
    Those agreeing to participate (to a maximum of six subjects) will provide a 20ml sample of venous blood taken as follows:
    5mL in to sodium heparin Vacutainer tube for plasma separation
    15mL in to EDTA Vacutainer tubes.
    Phlebotomy staff should use the same venepuncture episode as for the haematology and chemistry samples already required at that study visit. The blood taken will be additional to the other blood samples required at the visit.
    Each patient will also be asked to provide a sample of urine (>20ml) prior to leaving the clinic.
    The separated plasma, whole blood and urine samples will be placed on ice or in a refrigerator and within 4 hours transferred to the GLP test facility, at the University of Aberdeen.
    Samples will be aliquoted and frozen for assay validation work. Samples may be stored for up to 10 years to support the results of the validation work, and will not be used for genetic studies. This will be clear in the patient information leaflet and consent form. It is not anticipated that informative results will be available to return to the investigator and will not contribute to the study database.
    E.3Principal inclusion criteria
    To be eligible for the study all of the following criteria must be fulfilled:
    1. The patient may be of either sex and must be supervised by a carer who is competent to ensure compliance with the medication and who is willing to participate in completing the various assessments. The carer must provide written consent to his or her own participation in the study.
    2. Patients with capacity must give written informed consent to participate in this study. Patients who lack capacity to consent must be in agreement with entering into the study and have a personal legal representative giving written informed consent to their participation.
    3. The patient must have been ongoing in TRx-014-001 at time of study termination.
    E.4Principal exclusion criteria
    There are no exclusion criteria. All patients taking medication at the termination of study TRx-014-001 and who wish to participate are eligible for recruitment.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable in study TRx-014-001 was the change in cognitive function from Baseline as measured by the ADAS-cog. The individual patient data will be amalgamated with the data from TRx-014-001 to examine the long term potential of TRx0014 to slow the rate of decline by comparison with historical controls.
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    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 Information not present in EudraCT
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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.8.4.1Number of sites anticipated in Member State concerned12
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee No
    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 is defined by 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 years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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
    Patients who lack capacity to consent must be in agreement with entering into thestudy and have a personal legal representative giving written informed consent to their participation.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state125
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 125
    F.4.2.2In the whole clinical trial 150
    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)
    Plans for treatment or care after the subject has ended his/her participation in the trial are the expected normal treatment of the 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 Decision2007-07-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-09-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-12-02
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