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    The EU Clinical Trials Register currently displays   43800   clinical trials with a EudraCT protocol, of which   7272   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:2014-002013-37
    Sponsor's Protocol Code Number:TRx-237-020
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-12-16
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2014-002013-37
    A.3Full title of the trial
    An Open-Label, Extension Study of the Effects of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Alzheimer?s Disease or Behavioral Variant Frontotemporal Dementia
    Estudio de extensión abierto sobre los efectos de leuco-metiltioninio bis(hidrometanosulfonato) en sujetos con enfermedad de Alzheimer o demencia frontotemporal, variante conductual
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open-label extension study evaluating the safety and tolerability of leuco-methylthioninium dihydromesylate (LMTM) in subjects with Alzheimer's Disease or a rare form of dementia (Behavioral Variant Frontotemporal Dementia) who have completed an earlier Phase trial
    Estudio de extensión abierto sobre los efectos de leuco-metiltioninio bis(hidrometanosulfonato) en sujetos con enfermedad de Alzheimer o demencia frontotemporal, variante conductual
    A.4.1Sponsor's protocol code numberTRx-237-020
    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 organisationWorldWide Clinical Trials Ltd.
    B.5.2Functional name of contact pointManager. Regulatory affairs
    B.5.3 Address:
    B.5.3.1Street AddressSierra Morena, 37
    B.5.3.2Town/ cityVillanueva de la Canada
    B.5.3.3Post code28691
    B.5.3.4CountrySpain
    B.5.4Telephone number+3491812 53 83
    B.5.5Fax number+3491291 95 93
    B.5.6E-mailalbert.mesarey@wwctrials.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/10/805
    D.3 Description of the IMP
    D.3.1Product nameLeuco-methylthioninium bis(hydromethanesulfonate)
    D.3.2Product code LMTM/TRx0237
    D.3.4Pharmaceutical form 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 INNN/A
    D.3.9.1CAS number 1236208-20-0
    D.3.9.2Current sponsor codeTRx0237
    D.3.9.3Other descriptive nameN,N,N',N'-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate)
    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) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Alzheimer?s Disease and behavioral variant Frontotemporal Dementia
    Enfermedad de Alzheimer o demencia frontotemporal, variante conductual
    E.1.1.1Medical condition in easily understood language
    Alzheimer's Disease and Frontotemporal Dementia
    Enfermedad de Alzheimer o demencia frontotemporal, variante conductual
    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 17.1
    E.1.2Level PT
    E.1.2Classification code 10068968
    E.1.2Term Frontotemporal dementia
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.2System Organ Class 10029205 - Nervous system disorders
    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 objectives of this study are to provide subjects who have completed participation in a Phase 2 or Phase 3 trial continued access to therapy and to evaluate the long-term safety and tolerability of LMTM given in flexible doses of up to 300 mg/day.
    El objetivo del estudio es proporcionar a los pacientes que ha completado su participación en estudios de fase 2 o fase 3 un acceso continuado a la terapia y evaluar la seguridad y tolerancia a largo término del LMTM dado en dosis flexibles por encima de 300 mg/día.
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects with a diagnosis according to NIA/AA criteria of all cause dementia and probable Alzheimer?s disease at enrollment and who completed participation in one of the following three TauRx studies (inclusive of the 4-week post-treatment follow-up visit): TRx-237-005, TRx-237-008, or TRx-237-015.

    OR

    Subjects with a diagnosis of probable bvFTD according to the International Consensus Criteria for bvFTD at enrollment and who completed participation in TauRx study TRx-237-007 through Visit 9 (Week 52).

    Treatment will not be made available to subjects who have withdrawn from the double-blind study of prior participation prior to completion.

    2. Females of childbearing potential must continue to use adequate contraception defined as follows (or, if in Italy, agree to avoid pregnancy):
    ? Barrier method (such as condom, diaphragm or cervical/vault cap) with spermicidal foam, gel, film, cream, or suppository
    ? Intrauterine device [IUD] or system
    ? Oral or long-acting injected or implanted contraceptives for at least 3 months prior to Baseline
    ? Vasectomized partner (with the appropriate post-vasectomy documentation of the absence of spermatozoa in the ejaculate)
    ? True abstinence (when this is in line with the preferred and usual lifestyle of the subject)
    Subjects must agree to continue to maintain adequate contraception throughout participation in the study.

    3. Subject and/or, in the case of reduced decision-making capacity, legally acceptable representative(s) consistent with national law and IRB/EC approval, is/are able to read, understand, and provide written informed consent in the designated language of the study site
    ? In Germany, subjects must be able to provide their own written informed consent.

    4. Has an identified adult caregiver who meets the following criteria:
    ? Either lives with the subject or sees the subject on average for ? 1 hour/day ? 3 days/week, and 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
    ? Is willing to provide written informed consent for his/her own participation
    ? Is able to read, understand, and speak the designated language at the study site
    ? Agrees to accompany the subject to each study visit
    ? Is able to verify daily compliance with study drug

    5. Able to comply with the study procedures in the view of the investigator
    1. Sujetos con un diagnóstico conforme a los criterios NIA/AA de demencia por todas las causas y probable enfermedad de Alzheimer (EA) en la inclusión y que completaron la participación en uno de los tres estudios de TauRx siguientes (incluyendo la visita de seguimiento postratamiento a las 4 semanas): TRx-237-008, TRx-237-015 y TRx-237-005.

    O

    Sujetos con un diagnóstico de probable demencia frontotemporal, variante conductual (DFTvc) conforme a los Criterios del Consenso Internacional de DFTvc en la inclusión y que completaron la participación en el estudio de TauRx, TRx-237-007, hasta la visita 9 (semana 52).

    El tratamiento no estará disponible para los sujetos que abandonaron el estudio doble ciego en el que participaron previamente antes de completarlo.
    2. Las mujeres con capacidad de gestación deben continuar utilizando anticonceptivos eficaces (o, si están en Italia, aceptar evitar el embarazo) como se define a continuación:
    ? método de barrera (como preservativo, diafragma o capuchón cervical) con espermicida en espuma, gel, película, crema u óvulo; sistema o dispositivo intrauterino (DIU); anticonceptivos hormonales orales o inyectados o implantados de acción prolongada durante al menos 3 meses antes de la visita basal; o pareja vasectomizada (con ausencia documentada de espermatozoides en el eyaculado tras la vasectomía); o abstinencia real (cuando concuerda con el estilo de vida preferida y habitual del sujeto)
    ? los sujetos deben aceptar continuar utilizando anticonceptivos eficaces durante toda la participación en el estudio
    3. El sujeto y/o, en caso de una capacidad reducida para la toma decisiones, el(los) representante(s) legalmente autorizado(s) de conformidad con la legislación nacional y la aprobación del CEIC, son capaces de leer, entender y otorgar el consentimiento informado por escrito en el idioma designado del centro del estudio
    ? En Alemania, los sujetos deben ser capaces de otorgar su propio consentimiento informado por escrito
    4. El sujeto tiene un cuidador adulto identificado que cumple los siguientes criterios:
    ? o vive con el sujeto o ve al sujeto una media de ?1 hora/día ?3 días/semana y, en opinión del investigador, el contacto es suficiente para proporcionar una evaluación significativa de los cambios en la conducta y la función del sujeto con el tiempo y aportar información sobre la seguridad y la tolerabilidad
    ? quiere otorgar el consentimiento informado por escrito para su propia participación
    ? es capaz de leer, entender y hablar el idioma designado del centro del estudio
    ? acepta acompañar al sujeto a cada visita del estudio
    ? es capaz de verificar el cumplimiento diario con el medicamento del estudio
    5. El sujeto es capaz de cumplir con los procedimientos del estudio en la opinión del investigador
    E.4Principal exclusion criteria
    1. History of swallowing difficulties (note: study drug should be swallowed whole and MUST NOT be broken, crushed or chewed or dissolved in fluids prior to ingestion)

    2. Pregnant or breastfeeding

    3. Clinically significant laboratory, pulse co-oximetry, electrocardiogram, or imaging abnormality (in originating study) or emergent intercurrent illness that, in the judgment of the principal investigator, could result in the risk of participation outweighing the potential benefit

    4. Current participation in, or intent to enroll in, a clinical trial of a drug, biologic, device, or medical food
    1. Historia de dificultad para tragar (nota: el medicamento del estudio se debe tragar entero y NO DEBE romperse, triturarse, masticarse o disolverse en líquido antes de la ingesta)
    2. Estar embarazada o en periodo de lactancia materna
    3. Anomalía clínicamente significativa de laboratorio, pulsioximetría con niveles de CO, electrocardiograma o imagen (en el estudio original) o enfermedad intercurrente emergente que, en opinión del investigador principal, podrían hacer que el riesgo de participación fuera mayor que el posible beneficio
    4. Participación actual, o intención de inscribirse, en un ensayo clínico de un medicamento, producto biológico, dispositivo o alimento médico
    E.5 End points
    E.5.1Primary end point(s)
    Not applicable to this open-label extension study.
    No aplicable. Es un estudio abierto
    E.5.1.1Timepoint(s) of evaluation of this end point
    Not applicable to this open-label extension study.
    No aplicable. Es un estudio abierto
    E.5.2Secondary end point(s)
    Not applicable to this open-label extension study.
    No aplicable. Es un estudio abierto
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable to this open-label extension study.
    No aplicable. Es un estudio abierto
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability and resource utilisation
    Tolerabilidad y la utilización de recursos
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA72
    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
    Argentina
    Australia
    Belgium
    Bulgaria
    Canada
    Croatia
    Finland
    France
    Germany
    Italy
    Korea, Republic of
    Malaysia
    Netherlands
    Poland
    Romania
    Russian Federation
    Singapore
    Spain
    Taiwan
    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
    LVLS
    LVLS
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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.1.2.1Number of subjects for this age range: 1050
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 350
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    In the case of reduced decision-making capacity, legally acceptable representative(s) consistent with national law and IRB/EC approval, are able to read, understand, and provide written informed consent in the designated language of study site
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 670
    F.4.2.2In the whole clinical trial 1400
    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)
    The study will continue until alternate options for access to treatment are available, i.e., commercialization or, depending on country, on a Named Patient or compassionate basis or via a Managed Access Program.
    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 Decision2015-02-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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