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    Summary
    EudraCT Number:2017-003558-17
    Sponsor's Protocol Code Number:TRx-237-039
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2017-11-09
    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 number2017-003558-17
    A.3Full title of the trial
    Randomized, Double-Blind, Placebo-Controlled, Three-Arm, 12-Month, Safety and Efficacy Study of Hydromethylthionine Mesylate (LMTM) Monotherapy in Subjects with Alzheimer's Disease Followed by a 12-Month Open-Label Treatment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A comparison study of TRx0237 (LMTM) and placebo in patients with Alzheimer's Disease.
    A.4.1Sponsor's protocol code numberTRx-237-039
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03446001
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTauRx Therapeutics Ltd
    B.1.3.4CountrySingapore
    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 supportTauRx Therapeutics Ltd
    B.4.2CountrySingapore
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTauRx Therapeutics Ltd
    B.5.2Functional name of contact pointInformation Desk
    B.5.3 Address:
    B.5.3.1Street Address395 King Street
    B.5.3.2Town/ cityAberdeen
    B.5.3.3Post codeAB24 5RP
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441224440905
    B.5.6E-mailinfo@taurx.com
    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 nameLeuco-methylthioninium bis(hydromethanesulfonate)
    D.3.2Product code TRx0237
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    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 INNNot yet established
    D.3.9.1CAS number 1236208-20-0
    D.3.9.2Current sponsor codeTRx0237
    D.3.9.3Other descriptive nameLEUCO-METHYLTHIONINIUM BIS (HYDROMETHANESULFONATE)
    D.3.9.4EV Substance CodeSUB91958
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    D.8 Placebo: 2
    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
    Alzheimer’s Disease
    E.1.1.1Medical condition in easily understood language
    Alzheimer’s Disease
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To compare the LMTM dose of 16 mg/day with the placebo group on the following co-primary endpoints:
    a. ADAS-cog11
    b. ADCS-ADL23
    2. To assess the safety and tolerability of LMTM 16 mg/day given for up to 52 weeks
    E.2.2Secondary objectives of the trial
    1. To compare the LMTM dose of 16 mg/day with the placebo group in annualized rate of whole brain atrophy over 52 weeks as measured by brain MRI and quantified using the BSI
    2. To compare the LMTM dose of 16 mg/day with the placebo group in temporal lobe 18F-FDG-PET change in SUVR (normalized to pons) over 52 weeks, restricted to subjects with CDR 0.5 at Screening
    3. To compare the LMTM dose of 8 mg/day with the placebo group in temporal lobe 18F-FDG-PET change in SUVR (normalized to pons) over 52 weeks, restricted to subjects with CDR 0.5 at Screening
    4. To compare the LMTM dose of 16 mg/day with the placebo group in temporal lobe 18F FDG-PET change in SUVR (normalized to pons) over 52 weeks, restricted to subjects with CDR 0.5 at Screening
    5. To compare the LMTM dose of 8 mg/day with the placebo group in temporal lobe 18F-FDG-PET change in SUVR (normalized to pons) over 52 weeks, restricted to subjects with CDR 0.5 at Screening
    For more information please refer to protocol

    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A single blood sample will be obtained only from subjects who provide legally acceptable informed consent for genotyping evaluation of ApoE. The blood sample may be collected any time after eligibility for randomization and continued participation in the study has been confirmed but prior to Visit 7 (end of double-blind treatment period). A volume of approximately 2 mL is to be collected and shipped ambient to the central laboratory (Covance) on the day of collection. Genotyping results will not be provided to the study sites or to subjects.
    E.3Principal inclusion criteria
    To be eligible for enrollment in this study, a subject must meet all of the following inclusion criteria:

    1. AD, encompassing probable AD and MCI-AD based on 2011 NIA/AA criteria:
    • All cause dementia and probable AD (probable AD)
    In brief, subjects with probable AD dementia must have insidious onset, worsening impairment in at least two cognitive areas (learning and recall, language, executive function, visuospatial skills), sufficient to significantly interfere with work or usual activities, that is not explained by delirium, drugs, major psychiatric disorder, medical illness, cerebrovascular disease, other forms of dementia, or neurological disorder. The accuracy of the diagnosis will be confirmed independently by the diagnosing physician at site.
    OR
    • MCI-AD
    In subjects with MCI-AD, there should be evidence of concern about a change in cognition, in comparison with the person’s previous level verified by a knowledgeable informant or clinician. Other mild cognitive deficits may also be present, but there must be preservation of independence in functional abilities. Subjects should not meet the criteria for dementia. The cognitive changes must be mild and there must be no evidence of a significant impairment in social or occupational functioning. Impairments must not be explained by delirium, drugs, major psychiatric disorder, medical illness, cerebrovascular disease, other forms of dementia, or neurological disorder.
    of dementia, or neurological disorder.
    2. Documented PET scan that is positive for amyloid; if most recent PET scan was performed >3 years prior to Screening and was negative, it may be repeated (a negative amyloid PET scan within the 3 years prior to Screening is exclusionary)
    3. MMSE score of 16-27 (inclusive) at Screening, subject to stratification requirements
    4. Global CDR score of 0.5 to 2 at Screening (if 0.5, including a score of >0 in one of the functional domains: Community Affairs, Home and Hobbies, or Personal Care)
    5. Age <90 years at Screening
    6. Females must meet one of the following:
    • Surgically sterile (hysterectomy, bilateral salpingectomy / oophorectomy) for at least 6 months minimum
    • Have undergone bilateral tubal occlusion / ligation at least 6 months prior
    • Post-menopausal for at least 1 year
    • Using adequate contraception (a barrier method [such as condom, diaphragm or cervical/vault cap] with spermicidal foam, gel, film, cream, or suppository; intrauterine device [IUD] or system, or oral or long-acting injected or implanted hormonal contraceptives for at least 90 days prior to Baseline; or vasectomized partner [with the appropriate post-vasectomy documentation of the absence of spermatozoa in the ejaculate]) or true abstinence (when this is in line with the preferred and usual lifestyle of the subject); subjects must be competent to use adequate contraception and to agree to continue to maintain adequate contraception throughout participation in the study (including up to 4 weeks after the last dose of study drug)
    7. Subject and/or, in the case of reduced decision-making capacity, legally acceptable representative(s) (LAR(s)), consistent with local and national law, is able to read, understand, and provide written informed consent in the designated language of the study site
    8. Has one (or more) identified adult study partner (i.e., a caregiver or informant) who meets the following criteria:
    • Either lives with the subject, or in the investigator’s opinion, the extent of contact is sufficient to provide meaningful assessment of changes in subject behavior and function over time and provide information on safety and tolerability (e.g., sees the subject on average for ≥1 hour/day ≥3 days/week)
    • Is willing to provide written informed consent for his/her own participation
    • Is able to read, understand, and speak the designated language(s) at the study site
    • Agrees to accompany the subject to each study visit
    • Is able to verify compliance with study drug
    9. If the subject has previously taken either an AChEI, i.e., donepezil, galantamine, or rivastigmine, and/or memantine, it must have been discontinued prior to informed consent due to intolerance, lack of efficacy, or recommendation by the primary care provider
    • Subjects never previously treated with an AChEI and/or memantine may be enrolled if initiation of treatment with these medications is not planned for the time period during which the subject will be participating in this study
    10. Able to comply with the study procedures in the view of the investigator
    E.4Principal exclusion criteria
    1. Significant central nervous system disorder other than probable AD or MCI-AD
    2. Significant intracranial focal or vascular pathology seen on brain MRI scan that would, based on the independent reviewer imaging evaluation, lead to a diagnosis other than probable AD or MCI-AD, including but not limited to:
    • Large confluent white matter hyperintense lesions
    • Other focal brain lesions judged clinically relevant by the investigator
    • Evidence of a prior or current macrohemorrhage
    3. Clinical evidence or history of any of the following :
    • Cerebrovascular accident
    • Transient ischemic attack
    • Significant head injury, for example, associated loss of consciousness, skull fracture or persisting cognitive impairment
    • Other unexplained or recurrent loss of consciousness ≥15 minutes
    4. Diagnosed with epilepsy
    5. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria met:
    • Major depressive disorder
    • Schizophrenia
    • Other psychotic disorders, bipolar disorder
    • Substance (including alcohol) related disorders
    6. Metal implants in the head, pacemaker, cochlear implants, or any other non-removable items that are contraindications to MRI.
    7. Resides in hospital or moderate to high dependency continuous care
    8. Any physical disability that would prevent completion of study procedures or assessments
    9. History of swallowing difficulties
    10. Pregnant or breastfeeding
    11. G6PD deficiency based on World Health Organization classification
    12. History of significant hematological abnormality or current acute or chronic clinically significant abnormality, including:
    • History of hemoglobinopathy, myelodysplastic syndrome, hemolytic anemia, or splenectomy
    • Screening Hgb value below age/sex appropriate lower limit of the central laboratory normal range
    13. Abnormal serum chemistry laboratory value at Screening deemed to be clinically significant by the investigator. In addition, subjects with either of the following abnormalities must be excluded:
    • Creatinine clearance <30 mL/min
    • TSH above laboratory normal range
    14. Clinically significant cardiovascular disease or abnormal assessments such as:
    • Hospitalization for acute coronary syndrome or symptoms consistent with angina pectoris, within the 12 months preceding Baseline
    • Signs or symptoms of clinical heart failure within the 12 months preceding Baseline
    • Atrial fibrillation on Screening ECG or history of atrial fibrillation that is not currently controlled
    • QTcF at Screening >460 msec in males or >470 msec in females, or low or flat T waves making measurement of QT interval unreliable
    • Recent history of poorly controlled hypertension, systolic blood pressure >180 mmHg, or diastolic blood pressure >100 mmHg
    • Hypotension: systolic blood pressure <100 mmHg
    • Heart rate <48 bpm or >96 bpm by measurement of vital signs or by local ECG at Screening
    15. Pre-existing or current signs or symptoms of respiratory failure,
    • Subjects with currently diagnosed moderate to severe sleep apnea should be excluded; the definition of moderate to severe includes oxygen supplementation
    16.Concurrent acute or chronic clinically significant immunologic, hepatobiliary, or endocrine disease, and/or other unstable or major disease other than probable AD or MCI-AD; the following are specifically excluded:
    • Active hepatitis or primary biliary cirrhosis
    • Active Human T-Cell Lymphocytic Virus Type III, Lymphadenopathy Associated Virus, any mutants or derivatives of HLTV-III or LAV, any condition associated with active Acquired Immunodeficiency Syndrome or similar condition however named
    17.Diagnosis of cancer meeting either of the following criteria:
    • Newly diagnosed within past 2 years
    • Previous diagnosis of cancer that has required any form of intervention or treatment within the past 2 years
    18.Prior intolerance or hypersensitivity to MT-containing drug or methemoglobinemia induced by MT-containing drug, similar organic dyes, or any of the excipients
    19.Treatment currently or within 90 days before Baseline with any of the following:
    • Souvenaid®
    • Antipsychotics
    o Clozapine
    o Other antipsychotics are allowable provided they have not been initiated within 90 days before Baseline and preferably at a stable dose and regimen
    • Carbamazepine, primidone, valproate
    • Drugs for which there is a warning or precaution in the labeling about methemoglobinemia at approved doses (e.g., dapsone, local anesthetics such as benzocaine used chronically, primaquine, and related antimalarials)
    20. Current or prior participation in a clinical trial as follows:
    • Any clinical trial of LMTM
    • Clinical trial of a product for cognition prior to Baseline in which the last dose was received within 90 days prior to Baseline unless confirmed to have been randomized to placebo
    • A clinical trial of any other investigational drug, biologic, device, or medical food in which the last dose was received within 28 days prior to Baseline
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoints for Double-Blind Treatment Period
    • ADAS-cog11 (LMTM 16 mg/day versus placebo)
    • ADCS-ADL23 (LMTM 16 mg/day versus placebo)

    E.5.1.1Timepoint(s) of evaluation of this end point
    Through the trial
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints for Double-Blind Treatment Period
    • Annualized rate of whole brain atrophy on brain MRI using BSI (LMTM 16 mg/day versus placebo)
    • Difference in temporal lobe 18F-FDG-PET change in SUVR normalized to pons in subjects with CDR 0.5 at Screening (LMTM 16 mg/day versus placebo, and LMTM 8 mg/day versus placebo)
    • ADAS-cog11 and ADCS-ADL23 (LMTM 8 mg/day versus placebo)
    • Annualized rate of temporal and parietal lobe atrophy on brain MRI using BSI (LMTM 16 mg/day versus placebo, and LMTM 8 mg/day versus placebo)

    Secondary Endpoint for Open-Label, Delayed-Start Phase
    • Difference in disease progression on the co-primary clinical endpoints and the MRI imaging endpoint for subjects who started treatment in the double-blind treatment phase and those who started treatment in the
    open-label, delayed-start phase (referred to as "early" and "late" LMTM starters, respectively)
    • Only ADAS-cog11 will serve as a secondary endpoint; ADCS-ADL23 and other imaging endpoints are exploratory with the aim to be directionally supportive

    For exploratory endpoints, please refer to protocol.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the trial:


    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    open label study following double blind period.
    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.8.2.4Number of treatment arms in the trial3
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA51
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Canada
    France
    Italy
    Poland
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    Last Subject Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    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.1.2.1Number of subjects for this age range: 138
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 362
    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 Yes
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 165
    F.4.2.2In the whole clinical trial 500
    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)
    subjects who complete the study and receive treatment with LMTM up to and including the last open-label visit may be subsequently offered an opportunity to receive treatment with LMTM in a separate Expanded Access Program (EAP).

    Otherwise subject will return to the standard of care as determined by their physician.
    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 Decision2017-12-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-25
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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