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    EudraCT Number:2012-003647-30
    Sponsor's Protocol Code Number:LAQ-MS-305
    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:2012-10-29
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2012-003647-30
    A.3Full title of the trial
    A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS)
    Estudio multinacional, multicéntrico, aleatorizado, doble ciego, con grupos paralelos y controlado con placebo, seguido de un periodo de tratamiento activo, para evaluar la eficacia, la seguridad y la tolerabilidad de dos dosis de laquinimod administradas por vía oral (0,6 mg/día o 1,2 mg/día) en sujetos con esclerosis múltiple remitente-recurrente (EMRR)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study in subjects with relapsing-remitting multiple sclerosis
    (RRMS) consisting of two parts:
    First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo.
    Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug).
    Ensayo clínico en pacientes con esclerosis (EMRR) divido en dos partes:

    En la primera parte se evalua la eficacia, seguridad y tolerabilidad de dos dosis de laquinimod ( fármaco experimental) de 0.6 mg/dia o 1.2 mg/ administradas por via oral para comparlas con las del placebo.

    En la segund parte (para todos los pacientes reciviendo tratamiento activo) se evalua la eficacia, seguridad y tolerabilidad de dos dosis orales de laquinimod (fármaco experimental) de 0.6 mg al dia o 1.2 mg
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberLAQ-MS-305
    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 SponsorTeva Pharmaceutical Industries Ltd
    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 supportTeva Pharmaceutical Industries Ltd
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTeva Pharma GmbH
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressWaldeckerstrasse 7
    B.5.3.2Town/ cityMoerfelden-Walldorf
    B.5.3.3Post code64546
    B.5.4Telephone number000000000000
    B.5.5Fax number000000000000
    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 nameLaquinimod capsules 0.6 mg
    D.3.2Product code TV-5600
    D.3.4Pharmaceutical form Capsule, hard
    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 INNLAQUINIMOD
    D.3.9.1CAS number 248282-07-7
    D.3.9.2Current sponsor codeTV-5600
    D.3.9.3Other descriptive nameLaquinimod Sodium (USAN)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.6
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 placeboCapsule, hard
    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
    Relapsing remitting multiple sclerosis
    Esclerosis múltiple remitente
    E.1.1.1Medical condition in easily understood language
    Relapsing-remitting multiple sclerosis, is a chronic inflammatory disease that affects the central nervous system
    La esclerosis múltiple remitente-recurrente es una enfermedad inflamatoria que afecta al Sistema nervioso central.
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy, safety and tolerability of a daily dose of 0.6 mg and 1.2 mg of laquinimod as compared to placebo in subjects with relapsing remitting multiple sclerosis (RRMS).
    Estudio para evaluar la eficacia, seguridad y tolerabilidad de una dosis diaria de 0.6 mg y 1.2 mg de laquinimod comparada con placebo en pacientes con esclerosis múltiple remitente-recurrente.
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Ancillary-studies (sub-studies) are included in the main study protocol LAQ-MS-305, dated 15 August 2012 (final version)

    to investigate possible associations between genetic polymorphisms and response to laquinimod

    to evaluate the immunological response to treatment with laquinimod and further investigation of the potential mechanism of action

    to evaluate change in whole brain average Magnetization Transfer (MTR) to be used as an exploratory endpoint

    to evaluate the percent change in cervical cord volume to be used as an exploratory endpoint
    En el protocolo del estudio principal LAQ-MS-305 de fecha 15 de Agosto de 2012: se incluyen estudios auxiliares:

    - SUB-ESTUDIO DE MARCADORES GENETICOS para investigar las posibles asociaciones entre los polimorfismos.
    genéticos y la respuesta al laquinomd.

    - SUB-ESTUDIO INMUNOLÓGICO para evaluar la respuesta inmunológica al tratamiento con laquinomid e investigación mas a fondo del posible mecanismo de acción.

    -RTM RM SUB-SUDY para evaluar el cambio en el histograma de Transferencia de la Magnetización (RTM). Se utilizará como variable exploratoria.

    - SUB-ESTUDIO MEDULA CERVICARL MR. utilizará como variable exploratoria el cambio porcentual del volumen de la médula cervica.
    E.3Principal inclusion criteria
    1. Subjects must have a confirmed and documented MS diagnosis as defined by the Revised McDonald criteria, with relapse onset disease or a relapsing-remitting disease course.
    2. Subjects must be ambulatory with Kurtzke EDSS score of 0-5.5 in both screening and randomization visits.
    3.Subjects must be in a stable neurological condition, relapse-free and free of any corticosteroid treatment [intravenous (IV), intramuscular (IM) and/or per os (PO)] or adrenocorticotrophic hormone (ACTH), 60 days prior to randomization.
    4. Subjects must have experienced at least one documented relapse in the 12 months prior to randomization.
    5. Subjects must be between 18 and 55 years of age at screening, inclusive.
    6. Subjects must have disease duration of at least 6 months, but not more than 12 years (from the first symptom) prior to randomization.
    7. Women of child-bearing potential must practice an acceptable method of birth control until 30 days after the last dose of treatment was administered.
    8. Subjects must be able to sign and date a written informed consent prior to entering the study.
    9. Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
    1.Los sujetos deben tener un diagnóstico confirmado y documentado de EM definida por los criterios revisados de McDonald, con una recidiva como inicio de la enfermedad o evolución remitente-recurrente de la enfermedad.
    2.Los sujetos deben tener capacidad de deambulación con una puntuación en la EDSS de Kurtzke de 0-5,5 tanto en la visita de selección como en la de aleatorización.
    3.Los sujetos deben tener un estado neurológico estable, sin recidivas y sin tratamiento con corticosteroides [intravenoso (IV), intramuscular (IM) y/o por vía oral (PO)] ni hormona adrenocorticotropa (ACTH), 60 días antes de la aleatorización.
    4.Los sujetos deben haber experimentado al menos una recidiva documentada en los 12 meses previos a la aleatorización.
    5.Los sujetos deben tener entre 18 y 55 años en la selección, ambos inclusive.
    6.Los sujetos deben tener una duración de la enfermedad de al menos 6 meses, pero no más de 12 años (desde el primer síntoma) antes de la aleatorización.
    7.Las mujeres con capacidad fértil deben utilizar un método anticonceptivo aceptable hasta 30 días después de la administración de la última dosis del tratamiento [los métodos anticonceptivos considerados como aceptables en este estudio son: esterilización quirúrgica, dispositivos intrauterinos anticonceptivos orales, parches anticonceptivos, anticonceptivos inyectables de acción prolongada o métodos de doble barrera (preservativo o diafragma con espermicida)].
    8.Los sujetos deben ser capaces de firmar y fechar un consentimiento informado por escrito antes de ser incluidos en el estudio.
    9.Los sujetos deben estar dispuestos y ser capaces de cumplir con los requisitos del protocolo durante todo el estudio.
    E.4Principal exclusion criteria
    1. Subjects with progressive forms of MS.
    2. Subjects with Neuromyelitis Optica (NMO).
    3. Use of experimental or investigational drugs (including dimethyl fumarate and Teriflunomide)and/or participation in drug clinical studies within 6 months prior to randomization.
    4. Use of immunosuppressive agents, including fingolimod (Gilenya®) or cytotoxic agents, including Cyclophosphamide within 6 months prior to randomization.
    5. Use of either of the following within 2 years prior to randomization: natalizumab (Tysabri®), rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab.
    6. Previous treatment with glatiramer acetate (Copaxone®) Interferon-? (either 1a or 1b) or intravenous immunoglobulin (IVIG) within 2 months prior to randomization.
    7. Chronic (more than 30 consecutive days) systemic (IV, IM or PO) corticosteroid treatment within 2 months prior to randomization.
    8. Previous use of Mitoxantrone (Novantrone®), Cladribine, or alemtuzumab (CAMPATH-1H).
    9. Previous use of laquinimod.
    10. Previous total body irradiation or total lymphoid irradiation.
    11. Previous stem cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation.
    12. Use of moderate/strong inhibitors of CYP3A4 within 2 weeks prior to randomization.
    13. Use of inducers of CYP3A4 within 2 weeks prior to randomization.
    14. Pregnancy or breastfeeding.
    15. Serum levels ?3xULN of either ALT or AST at screening.
    16. Serum direct bilirubin which is ?2xULN at screening.
    17. Subjects with a clinically significant or unstable medical or surgical condition or any other condition that cannot be well-controlled by the allowed medications permitted in the study protocol that would preclude safe and complete study participation, as determined by medical history, physical examinations, ECG, laboratory tests MRI or chest X-ray.
    18. A known history of sensitivity to gadolinium (Gd).
    19. GFR ? 60 mL/min at the screening visit.
    20. Inability to successfully undergo MRI scanning.
    21. Subjects who underwent endovascular treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI) within 3 months prior to randomization.
    22. Known hypersensitivity that would preclude administration of laquinimod capsule, such as hypersensitivity to: mannitol, meglumine or sodium stearyl fumarate.
    1.Sujetos con formas progresivas de EM.
    2.Sujetos con neuromielitis óptica (NMO).
    3.Utilización de fármacos experimentales o en investigación (incluyendo dimetil fumarato y teriflunomida) y/o participación en estudios clínicos con fármacos en los 6 meses anteriores a la aleatorización.
    4.Utilización de inmunosupresores, incluyendo fingolimod (Gilenya®) o fármacos citotóxicos, incluyendo ciclofosfamida, en los 6 meses anteriores a la aleatorización.
    5.Utilización de alguno de los siguientes fármacos en los 2 años anteriores a la aleatorización: natalizumab (Tysabri®), rituximab, ocrelizumab, atacicept, belimumab u ofatumumab.
    6.Tratamiento previo con glatiramer acetato (Copaxone®), interferón-? (1a o 1b) o inmunoglobulinas intravenosas (IGIV) en los 2 meses anteriores a la aleatorización.
    7.Tratamiento sistémico (IV, IM o PO) crónico (más de 30 días consecutivos) con corticosteroides en los 2 meses anteriores a la aleatorización.
    8.Utilización previa de mitoxantrona (Novantrone®), cladribina o alemtuzumab (CAMPATH-1H).
    9.Utilización previa de laquinimod.
    10.Irradiación corporal total o irradiación linfoide total previas.
    11.Tratamiento previo con células madre, trasplante autólogo de médula ósea o trasplante alogénico de médula ósea.
    12.Utilización de inhibidores moderados/potentes de CYP3A4 en las 2 semanas anteriores a la aleatorización.
    13.Utilización de inductores de CYP3A4 en las 2 semanas anteriores a la aleatorización.
    14.Embarazo o lactancia materna.
    15.Niveles séricos de ALT o AST ?3xLSN en la selección.
    16.Bilirrubina directa sérica ?2xLSN en la selección.
    17.Sujetos con un trastorno médico o quirúrgico inestable o clínicamente significativo o cualquier otro trastorno que no puede controlarse bien con las medicaciones permitidas en el protocolo del estudio y que impediría la participación segura y completa en el estudio, de acuerdo con la historia clínica, las exploraciones físicas, los ECG, los análisis de laboratorio, las RMN o las radiografías de tórax.
    18.Antecedentes conocidos de sensibilidad a gadolinio (Gd).
    19.TFG ? 60 ml/min en la visita de selección.
    20.Incapacidad para someterse de forma satisfactoria a una RMN.
    21.Sujetos sometidos a tratamiento endovascular por Insuficiencia Venosa Cerebroespinal Crónica (IVCEC) en los 3 meses anteriores a la aleatorización.
    22.Hipersensibilidad conocida a fármacos que impediría la administración de las cápsulas de laquinimod, como hipersensibilidad a: manitol, meglumina o estearil fumarato sódico
    E.5 End points
    E.5.1Primary end point(s)
    Time to Confirmed Disease Progression (CDP) during Period 1.
    CDP is defined as an increase in EDSS of > and = 1 point from baseline for subjects with baseline EDSS of < and = 5.0, or an increase in EDSS of > and = 0.5 points from baseline for subjects with baseline EDSS of 5.5. Analysis will be performed at the completion of Period 1.
    Tiempo hasta la Progresión Confirmada de la Enfermedad (PCE) durante el Periodo 1.
    La PCE se define como un aumento de > and= 1 punto con respecto al valor basal en la EDSS en los sujetos con una EDSS basal de ?5,0, o un aumento de > and =0,5 puntos con respecto al valor basal en la EDSS en los sujetos con una EDSS basal de 5,5.
    El análisis se realizará a la finalización del Periodo 1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation will be performed at months -1 (screening), 0 (baseline) and every 3 months thereafter and until completion visit of Period 1
    La evaluación se hará en el mes - 1 ( Seleccion), 0 (Basal) y cada 3 meses pposteriorment hasta la finalización del Periodo 1.
    E.5.2Secondary end point(s)
    -Brain atrophy as defined by the percent change in brain volume from baseline to month 15

    -The time to first confirmed relapse during Period 1.
    - Atrofia cerebral determinada mediante el Cambio Porcentual del Volumen Cerebral (CPVC) desde el momento basal hasta el mes 15.
    - Tiempo hasta la primera recidiva confirmada durante el periodo 1.
    E.5.2.1Timepoint(s) of evaluation of this end point
    In terms of brain atrophy:

    evaulation at baseline and at month 15

    In terms relapse evaluation:

    Evaluation will be done at each timepoint during the study once any symptoms suggestive of a relapse appear / are reported by any subject.
    - Atrofia cerebral: Evaluación en basal y en el mes 15.

    - Evaluacion de recidiva: Se realizará durante el estudi cada vez que el paciente informe sobre cualquier sintoma sugestivo de recidiva.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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. 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 Yes
    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 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA120
    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
    Bosnia and Herzegovina
    Korea, Democratic People's Republic of
    Macedonia, the former Yugoslav Republic of
    Moldova, Republic of
    Puerto Rico
    Russian Federation
    South Africa
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months3
    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: 1800
    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 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 state66
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 700
    F.4.2.2In the whole clinical trial 1800
    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)
    Standard of care treatment
    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 Decision2013-01-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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