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    Summary
    EudraCT Number:2009-015162-57
    Sponsor's Protocol Code Number:P06153
    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:2011-03-31
    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 number2009-015162-57
    A.3Full title of the trial
    Estudio de extensión de fase 3, de 40 semanas, controlado con tratamiento activo, doble ciego y doble simulación del preladenant en sujetos con enfermedad de Parkinson de moderada a grave (fase 3; n. de protocolo P06153)
    A.4.1Sponsor's protocol code numberP06153
    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 SponsorSchering-Plough Research Institute, a division of Schering Corporation
    B.1.3.4CountryUnited States
    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 namePreladenant
    D.3.2Product code SCH 420814
    D.3.4Pharmaceutical form Coated tablet
    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 INNPreladenant
    D.3.9.1CAS number 377727-87-2
    D.3.9.2Current sponsor codeSCH 420814
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2 to 10
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Azilect
    D.2.1.1.2Name of the Marketing Authorisation holderLundbeck (Schweiz) AG
    D.2.1.2Country which granted the Marketing AuthorisationSwitzerland
    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 nameAzilect
    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 INNRasagiline mesylate
    D.3.9.1CAS number 161735-79-1
    D.3.9.3Other descriptive nameRASAGILINE MESILATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Azilect
    D.2.1.1.2Name of the Marketing Authorisation holderTeva Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameAzilect
    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 INNRasagiline mesylate
    D.3.9.1CAS number 161735-79-1
    D.3.9.3Other descriptive nameRASAGILINE MESILATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated 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 placeboCapsule
    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
    Enfermedad de Parkinson
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10061536
    E.1.2Term Parkinson's disease
    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
    Evaluar la seguridad y tolerabilidad a largo plazo del preladenant en sujetos con enfermedad de Parkinson (EP) de moderada a grave.
    E.2.2Secondary objectives of the trial
    Caracterizar la eficacia a largo plazo del preladenant en sujetos con EP de moderada a grave.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    En este ensayo participarán sujetos adultos con un diagnóstico al inicio del ensayo original (P04938 o P07037) de enfermedad de Parkinson de moderada a grave con presencia de fluctuaciones motoras que hayan completado el periodo de tratamiento de 12 semanas del ensayo original.Los sujetos deben haber completado el ensayo P04938 o P07037.
    Cada sujeto (o su representante legal) debe estar dispuesto a dar su consentimiento informado por escrito para el ensayo P06153 y ser capaz de hacerlo. En el caso de que un sujeto no pueda dar su consentimiento independiente, un representante legal puede dar su consentimiento informado por escrito.
    Los sujetos deben poder cumplir los calendarios de dosis y visitas.
    Los sujetos deben estar bajo tratamiento con levodopa (L-dopa).
    Los sujetos pueden estar recibiendo tratamiento con cualquier otra medicación complementaria adicional para la EP incluida en la siguiente tabla.
    Nota: Los sujetos que únicamente reciben tratamiento con L-dopa pueden incluirse en este ensayo.
    (Amantadina, Anticolinérgicos, Inhibidores de la dopa descarboxilasa, Agonistas de la dopamina, Entacapona, L-dopa)
    Cada sujeto debe presentar resultados de análisis clínicos de laboratorio (hematología, bioquímica y análisis de orina) dentro de los límites normales o clínicamente aceptables para el investigador según se demuestre en los últimos resultados de análisis disponibles del estudio original (P04938 o P07037), y ningún resultado se situará dentro de los parámetros de exclusión descritos a continuación en los criterios de exclusión relativos a hallazgos hepáticos.
    No ha habido cambios en el estado serológico o no se han producido hallazgos que justifiquen su determinación (para citomegalovirus [CMV], virus de Epstein-Barr [VEB] y hepatitis B, C y E).
    Cada sujeto debe presentar resultados de una exploración física dentro de los límites normales, incluyendo una presión arterial dentro de los límites normales o límites clínicamente aceptables para el investigador y fuera de los parámetros de exclusión descritos a continuación en los criterios de exclusión para la presión arterial.
    Todos los sujetos sexualmente activos o que tengan previsto ser sexualmente activos deben acceder a utilizar un método anticonceptivo altamente eficaz durante la participación del sujeto en el estudio y durante las dos semanas posteriores a la última dosis del fármaco del estudio. Los sujetos de sexo masculino no deben donar esperma en las dos semanas posteriores a la última dosis del fármaco del estudio. Los datos completos sobre los requisitos anticonceptivos se especifican en la sección 7.7.1.7 del protocolo.
    E.4Principal exclusion criteria
    El sujeto no debe haber sido retirado de los ensayos P04938 o P07037 bajo ningún concepto.
    El sujeto no debe presentar una enfermedad médica inestable grave o en curso (p. ej., cualquier enfermedad cardíaca clínicamente significativa, hipotensión ortostática sintomática, epilepsia o dependencia de alcohol/drogas).
    El sujeto no debe presentar diabetes mal controlada (por ejemplo, HbA1c > 8,5) o una función renal significativamente anormal (p. ej., creatinina > 2,0 mg/dl) en opinión del investigador.
    Como continuación de los criterios de retirada de tipo hepático de los estudios originales (P04938 y P07037), cualquier sujeto con valores elevados de alanina aminotransferasa (ALT) aspartato aminotransferasa (AST) o bilirrubina total (BIL-T), según se demuestre en los resultados del análisis más reciente de bioquímica en el estudio original, que cumpla uno de los siguientes criterios:
    ALT o AST > 8 x LSN.
    ALT o AST > 5 x LSN durante más de dos semanas.
    ALT o AST > 3 x LSN y (BIL-T > 2 x LSN o índice normalizado internacional [INR] > 1,5 por causa distinta a anticoagulación) en la misma visita.
    ALT o AST > 3 x LSN con aparición de agravación de la fatiga, náuseas, vómitos, dolor o dolor a la palpación en el cuadrante superior derecho, fiebre, erupción cutánea y/o eosinofilia (> 5%).
    Como continuación de los criterios de retirada de la presión arterial (PA) de los estudios originales (P04938 y P07037), cualquier sujeto que cumpla los siguientes criterios en la segunda de dos visitas consecutivas separadas por siete días (es decir, el sujeto ya cumple uno de los criterios de PA siete días antes de la visita de selección del estudio P06153):
    PA sistólica > o = 180 mm Hg o PA diastólica > o = 105 mm Hg, o
    Una elevación de la PA inicial en el estudio original (P04938 o P07037) de la PA sistólica > o = 40 mm Hg o de la PA diastólica > o =20 mm Hg.
    El sujeto no debe presentar antecedentes de cáncer primario o recurrente en los cinco últimos años, con la excepción del cáncer de piel de células basales o células escamosas adecuadamente tratado, cáncer cervical in situ o cáncer de próstata in situ con antígeno prostático específico (PSA) normal después de la resección.
    El sujeto no debe presentar un consumo diario medio de más de 180 ml de vino o equivalente.
    Medicamentos concomitantes prohibidos: El sujeto no debe recibir tratamiento o iniciar tratamiento con ninguno de los medicamentos enumerados en la siguiente tabla.
    El sujeto no debe haber recibido tratamiento con ninguno de los medicamentos incluidos en la siguiente tabla en un periodo menor que el indicado antes del día 1 del estudio P06153.
    Nota: Deben seguirse las advertencias y contraindicaciones indicadas en la información de prescripción para los medicamentos permitidos (mostrados en los criterios de inclusión).
    E.5 End points
    E.5.1Primary end point(s)
    Los criterios de valoración de la seguridad están relacionados con el objetivo principal del ensayo. Los criterios de valoración de la eficacia incluirán los cambios desde el inicio en cada uno de los siguientes elementos:
    Puntuación de la MoCA; Puntuación del EQ-5D; Puntuación del PDQ-39; Puntuación del BDI-II; Puntuación de la Escala de la Apatía; Datos del diario que incluyen los siguientes criterios de valoración de la eficacia: Media de horas al día en estado off, Media de horas al día en estado on, Media de horas al día en estado on sin discinesias molestas, Media de horas al día en estado on con discinesias molestas, Proporción de tiempo on sin discinesias, Proporción de tiempo on sin discinesias molestas, Proporción de tiempo on con discinesias molestas, Tiempo total medio de sueño; Puntuación total del UPDRS en estado on: Puntuación del UPDRS para las partes 1, 2 y 3 combinadas, Puntuación del UPDRS para las partes 2 y 3 combinadas, Puntuaciones de las subescalas del UPDRS para las partes 1, 2, 3 y 4, Dominio del temblor del UPDRS, parte 3.
    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 No
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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) Yes
    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 EEA73
    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 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 months6
    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 months6
    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 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) 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 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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 480
    F.4.2.2In the whole clinical trial 750
    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 Decision2011-05-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-05-23
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