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    Summary
    EudraCT Number:2008-008712-98
    Sponsor's Protocol Code Number:CAFQ056A2208
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-04-27
    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 number2008-008712-98
    A.3Full title of the trial
    Estudio doble ciego, controlado con placebo, de dosis fija, multicéntrico de 13 semanas de seguimiento, para evaluar la eficacia y seguridad de AFQ056 en la reducción de las discinesias inducidas por levodopa, moderadas a graves, en pacientes con enfermedad de Parkinson
    A.4.1Sponsor's protocol code numberCAFQ056A2208
    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 SponsorNovartis Farmacéutica S.A
    B.1.3.4CountrySpain
    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 nameAFQ056
    D.3.2Product code AFQ056
    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.3.9.3Other descriptive nameAFQ056
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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 nameAFQ056
    D.3.2Product code AFQ056
    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.3.9.3Other descriptive nameAFQ056
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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 nameAFQ056
    D.3.2Product code AFQ056
    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.3.9.3Other descriptive nameAFQ056
    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) 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 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
    discinesias inducidas por levodopa en pacientes con enfermedad de Parkinson
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10013916
    E.1.2Term Dyskinesia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demostrar la eficacia en la reducción de las discinesias, medida por el cambio en la puntuación total de la AIMS modificada (Escala de Movimientos Involuntarios Anormales) desde la basal hasta la visita de la semana 12, de cinco dosis fijas de AFQ506 en comparación con placebo en pacientes con DIL-EP moderadas a graves.
    Calcular la relación dosis-respuesta entre cinco dosis fijas de AFQ506 y placebo tras 12 semanas de tratamiento, medida por los cambios desde la basal en la puntuación total de la AIMS modificada
    E.2.2Secondary objectives of the trial
    Evaluar la eficacia de cinco dosis fijas de AFQ506 en comparación con placebo en la discapacidad debida a discinesias, medida por el cambio en la puntuación total de la PDYS-26 (Escala de discinesias de 26 ítems para la enfermedad de Parkinson) desde la basal hasta la visita de la semana 12
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 30-80 años de edad (inclusive)
    2. hombres y mujeres
    Las mujeres deben haber sido sometidas a esterilización quirúrgica o llevar 1 año en período postmenopáusico o, en caso de ser mujeres en edad fértil, deben estar utilizando dos métodos anticonceptivos
    3. pacientes ambulatorios, que residan en la comunidad (no se permite a los pacientes ingresados en centros asistenciales)
    4. presentar un diagnóstico clínico de enfermedad de Parkinson según los criterios diagnósticos clínicos en la enfermedad de Parkinson de la UK Parkinson?s Disease Society Brain Bank (Apéndice 1)
    5. puntuación ? 2 en el ítem 32 de la UPDRS (es decir, discinesias presentes durante más del 25% del tiempo) y ? 2 en el ítem 33 de la UPDRS (es decir, moderada o gravemente discapacitado)
    6. inicio de discinesias durante al menos 3 meses antes de la aleatorización
    7. haber estado tomando levodopa durante al menos los 3 años anteriores a la aleatorización o, si la duración del tratamiento es ? 3 años, en tal caso deberán haber mostrado una claro grado de respuesta (UPDRS, parte III) al tratamiento con levodopa
    8. estar en régimen de tratamiento estable con levodopa y otro tratamiento antiparkinsoniano durante al menos las 4 semanas previas a la primera visita basal (BL1) con optimización de la dosis según lo determine el clínico que realice el reclutamiento. Además de este tratamiento estable, se permiten hasta tres dosis por semana de levodopa soluble o apomorfina subcutánea para optimizar el régimen de tratamiento para aliviar las fluctuaciones (períodos ?off?).
    9. demostrar capacidad para rellenar, en una sesión formativa realizada en la consulta y durante el período basal previo a la aleatorización, el diario con puntuaciones exactas del tiempo ?on?/?off? y de las discinesias, obteniéndose al menos un 66% de concordancia entre el paciente y el investigador/coordinador el día en el que el paciente presentó un tiempo ?on? sin discinesias, ?on? con discinesias, y tiempo ?off?
    10. cooperar y estar dispuesto a completar todos los aspectos del estudio y ser capaz de hacerlo, de acuerdo con el juicio del investigador
    11. deberá otorgar el consentimiento informado por escrito antes de que se realice ninguno de los procedimientos relacionados con el estudio
    12. contar con un cuidador/informador familiar, salvo que el investigador considere que el apoyo no es necesario
    E.4Principal exclusion criteria
    1. signos clínicos que sugieran una forma atípica o secundaria de enfermedad de Parkinson (p. ej., parálisis supranuclear progresiva, atrofia multisistémica)
    2. antecedentes de tratamiento quirúrgico debido a EP, incluida la estimulación cerebral profunda
    3. una puntuación de 5 en la evaluación del estado ?on? de la Escala modificada de Hoehn y Yahr (UPDRS Parte V) en la selección
    4. incapaz (en opinión del Investigador Principal) de mantener la dosis estable actual de sus medicaciones antiparkinsonianas durante el ensayo
    5. cualquier enfermedad avanzada, grave o inestable (distinta a EP) que pueda interferir con las evaluaciones de los resultados del estudio principales y secundarios
    6. antecedentes de enfermedad maligna de cualquier sistema orgánico (distinta a carcinoma basocelular de la piel localizado o cáncer de próstata no invasivo y no metastásico que haya sido tratado eficazmente), tratada o no tratada, en los últimos 5 años, independientemente de si existen indicios de recurrencia local o metástasis
    7. signos de demencia (o MMSE ? 26 en la Selección), trastorno depresivo mayor no tratado o ineficazmente tratado, o que actualmente presente alucinaciones/psicosis que precisen de tratamiento antipsicótico, y/o estados de confusión (DSM-IVR, Manual diagnóstico y estadístico de los trastornos mentales, 4ª edición, revisado)
    8. tratamiento con cualquiera de los siguientes
    ? tratamiento previo con AFQ056
    ? tratamiento actual con medicaciones concomitantes que sean inhibidores fuertes o moderados de CYP3A4 (véase Apéndice 2)
    ? medicación anticolinérgica de acción central, 1 semana antes de la visita BL1
    ? amantadina en las 3 semanas anteriores a la visita BL1
    ? metoclopramida en las 4 semanas anteriores a la visita BL1
    ? tratamiento inestable con domperidona, antidepresivos, y ansiolíticos en las 6 semanas anteriores a la visita BL1. En este estudio se permite la participación de pacientes con tratamiento estable (? 6 semanas) con domperidona (que no exceda 30 mg/día), antidepresivos, y ansiolíticos
    ? neurolépticos típicos o atípicos en los 3 meses anteriores a la visita BL1
    ? otros fármacos en investigación en los 30 días o 5 vidas medias de la visita BL1, lo que sea más largo
    9. valores de laboratorio de la selección que incluyan AST, ALT, bilirrubina total o creatinina ? 1,5 X LSN (límite superior de normalidad) para el laboratorio central
    10. síndrome de QT largo o QTc > 450 mseg en hombres y > 470 mseg en mujeres en la selección o basal
    11. ha participado en un estudio antidiscinético en las 4 semanas anteriores a la visita BL1
    12. cualquier paciente incapaz o que no esté dispuesto a participar en todas las actividades relacionadas con el estudio
    45
    E.5 End points
    E.5.1Primary end point(s)
    La AIMS es una escala fiable y muy utilizada para evaluar las discinesias (Guy 1976). Originalmente se desarrolló como una escala de 12 ítems para evaluar a pacientes con discinesia tardía y, por consiguiente, hace hincapié en las discinesias orofaciales. La versión modificada de la escala que se utiliza en este estudio se centra en seis partes distintas del cuerpo (cara/cuello, tronco, y cuatro extremidades) y evalúa los movimientos anormales de 0 (ninguno) a 4 (graves con una marcada alteración de la función) con una puntuación máxima de 24.

    Se realizará en el screening, visita basal y semanas 1,2,3,6,9,12 y 13
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    assess validity and reliability of dyskinesia scales
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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.8.3 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    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 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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 234
    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 Decision2009-07-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-06-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-12-03
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