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    Summary
    EudraCT Number:2007-000350-31
    Sponsor's Protocol Code Number:CENA713B2315
    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:2007-12-21
    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 number2007-000350-31
    A.3Full title of the trial
    Estudio prospectivo, multicéntrico y en condiciones abiertas de 76 semanas de duración para evaluar el efecto a largo plazo de Exelon® cápsula y parche transdérmico en el empeoramiento de los síntomas motores subyacentes de la EP en pacientes con demencia leve a moderadamente grave asociada a enfermedad de Parkinson (DEP)
    A.4.1Sponsor's protocol code numberCENA713B2315
    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 Yes
    D.2.1.1.1Trade name Exelon
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical 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 INNrivastigmine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.5
    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 Yes
    D.2.1.1.1Trade name Exelon
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical 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 INNrivastigmine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.0
    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 Yes
    D.2.1.1.1Trade name Exelon
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical 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 INNrivastigmine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.5
    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: 4
    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 Yes
    D.2.1.1.1Trade name Exelon
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical 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 INNrivastigmine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.0
    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: 5
    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 Yes
    D.2.1.1.1Trade name Exelon 4.6 mg/24 h transdermal patch
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Transdermal patch
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPTransdermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNrivastigmine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9
    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: 6
    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 Yes
    D.2.1.1.1Trade name Exelon 9.5 mg/24 h transdermal patch
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Transdermal patch
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPTransdermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNrivastigmine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Demencia leve a moderadamente grave asociada a enfermedad de Parkinson (DEP).
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10012284
    E.1.2Term Dementia due to Parkinson's disease
    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 a largo plazo de Exelon® en cápsula (12 mg/día) durante un período de 76 semanas mediante valoración del empeoramiento de los síntomas motores subyacentes de la EP en pacientes con DEP leve a moderadamente grave. El objetivo primario se evaluará midiendo:
    • Las reacciones adversas (RA) predefinidas debidas, o potencialmente debidas a, la exacerbación de los síntomas motores de la EP (temblor, rigidez muscular, bradicinesia, caídas)
    • Interrupciones del fármaco del estudio como consecuencia de RA predefinidas secundarias, o potencialmente secundarias, a una exacerbación de los síntomas motores de la EP (temblor, rigidez muscular, bradicinesia, caídas)
    E.2.2Secondary objectives of the trial
    * Evaluar la seguridad a largo plazo de Exelon® en cápsula (12 mg/día) durante un período de 76 semanas mediante valoración del empeoramiento de los síntomas motores subyacentes de la EP en pacientes con DEP leve a moderadamente grave.
    *Evaluar el efecto de Exelon® en cápsula y en parche
    *Evaluar la eficacia de Exelon® en cápsula y en parche basándose en: la función cognitiva, los síntomas neuropsiquiátricos, la capacidad de llevar a cabo las actividades básicas y complejas de la vida diaria.
    *Evaluar la eficacia, la seguridad y la tolerabilidad (incluida la incidencia de reacciones adversas gastrointestinales, el empeoramiento de los síntomas motores de EP y el flujo espiratorio máximo) de Exelon® en cápsula y en parche.
    *Evaluar la adhesividad del parche de Exelon® en los pacientes con EA y DEP.
    *Analizar el impacto de los genotipos ApoE y BuChE y de los biomarcadores inflamatorios en variables de seguridad y eficacia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Edad entre 50 y 80 años (ambas inclusive);
    2. Hombres y mujeres que no sean potencialmente fértiles (esterilización quirúrgica o llevar un año en estado postmenopáusico);
    3. Tener un diagnóstico clínico de enfermedad de Parkinson idiopática conforme a los criterios diagnósticos clínicos de la Parkinson´s Disease Society Brain Bank de Reino Unido (véase el Apéndice 2);
    4. Tener un diagnóstico clínico de demencia en la enfermedad de Parkinson conforme a los criterios DSM-IV (Código 294.1) (véase Apéndice 3), con inicio de los síntomas de demencia al menos dos años después del primer diagnóstico de enfermedad de Parkinson idiopática;
    5. Tener una puntuación MMSE ≥ 10 e ≤ 24 (sólo en la visita de selección, visita 1);
    6. Poseer una formación académica suficiente para poder leer, escribir y comunicarse de manera efectiva durante el estado premórbido;
    7. Actitud de cooperación, con voluntad de llevar a cabo todos los aspectos del estudio y estar capacitado para ello, ya sea solo o con la ayuda de un cuidador responsable a criterio del investigador;
    8. Vivir con alguna persona de la comunidad a lo largo de todo el estudio o, en caso de que se viva solo, que mantenga contactos regulares con su cuidador principal;
    9. Contar con un único cuidador, remunerado o no, dispuesto a asumir la responsabilidad de supervisar el tratamiento (por ej., aplicación y retirada del parche cada día aproximadamente a la misma hora), de evaluar el estado del paciente a lo largo de todo el estudio, y de aportar información para las evaluaciones de seguridad y eficacia de acuerdo con todos los requerimientos del protocolo;
    10. Haber proporcionado el consentimiento informado por escrito si el paciente conserva sus facultades mentales (o bien un representante legalmente aceptable si él está incapacitado legalmente) antes de tomar parte en el estudio. Los cuidadores también tendrán que proporcionar su consentimiento informado por escrito.
    E.4Principal exclusion criteria
    1. Presencia de enfermedad en estadio avanzado, grave, o inestable de cualquier tipo que pueda interferir en las evaluaciones de las variables primaria y secundaria;
    2. Puntuación de 5 en la escala modificada de Estadios de Hoehn y Yahr (UPDRS Parte V) en fase “on” en el momento de la selección;
    3. Diagnóstico actual de cualquier enfermedad neurodegenerativa primaria distinta a EP idiomática, por ejemplo, enfermedad de Alzheimer, demencia frontotemporal, enfermedad de Huntington, demencia con cuerpos de Lewy, síndromes Parkinson Plus distintos a la DEP (por ej., parálisis supranuclear progresiva o degeneración olivopontocerebelar);
    4. Diagnóstico actual de cualquier demencia tratable (hipotiroidismo, sífilis, déficit de vitamina B12 o folato, hidrocefalia, hematoma subdural crónico que el investigador ha documentado como causa de la demencia. Pueden reclutarse los pacientes que están recibiendo tratamiento estable para el hipotiroidismo y el déficit de vitamina B12 y folato (no considerado responsable de la demencia por el investigador). No se consideran elegibles para tomar parte en el estudio los pacientes con pruebas diagnósticas de laboratorio anómalas en el momento de la selección y que no se han documentado previamente o investigado más exhaustivamente;
    5. Diagnóstico actual de demencia vascular probable conforme a los criterios de National Institute of Neurological Disorders and Stroke and the Association Internationale pour la Recherche et l’Enseignement en Neurosciences (NINDS-AIREN (véase Apartado 4);
    6. Diagnóstico actual de episodio depresivo mayor conforme a los criterios DSM-IV (Código 296), o de cualquier otro diagnóstico en el eje 1 del DSM-VI que pueda interferir en la respuesta del paciente al fármaco del estudio, incluidos el trastorno bipolar o la esquizofrenia, documentados mediante evaluación psiquiátrica. Pueden reclutarse pacientes con depresión mayor en la visita basal que se hallan clínicamente estables bajo tratamiento;
    7. Diagnóstico actual de trastorno convulsivo activo y no controlado;
    8. Discapacidad que pueda impedir al paciente llevar a cabo todos los requerimientos del estudio y que, en particular, interfiera en la evaluación de la demencia (por ej., ceguera, sordera, síntomas extrapiramidales intenso durante la fase “on”);
    9. Antecedentes de cirugía cerebral estereotácxica para la enfermedad de Parkinson (por ej., palidotomía, estimulación cerebral profunda, trasplante de tejido);
    10. Diagnóstico actual o ECG, en el momento de la selección o en la visita basal, que revela evidencia de bradicardia (< 50 latidos por minuto, síndrome del seno enfermo, defectos de conducción (bloqueo seno-auricular, bloqueo aurículo-ventricular de segundo o tercer grado);
    11. Diagnóstico actual de enfermedades asmáticas agudas, graves o inestables;
    12. Obstrucción urinaria clínicamente significativa;
    13. Diagnóstico actual de úlcera péptica activa no controlada o hemorragia gastrointestinal en los últimos tres meses;
    14. Evidencia de valores elevados en las pruebas funcionales hepáticas, en particular, de fosfatasa alcalina (FA), ALT (SGPT), AST (SGOT) o gammaglutamiltransfera (GGT) superiores 3 veces el límite superior del rango normal;
    15. Sensibilidad farmacológica exagerada o hipersensibilidad documentada a fármacos similares a Exelon® o a otros compuestos colinérgicos;
    16. Pacientes que están tomando antipsicóticos y que no han recibido dosis estables de antipsicóticos atípicos durante las cuatro semanas anteriores a la visita basal;
    17. Pacientes que han tomado parte con anterioridad en algún ensayo clínico de fármacos para la demencia;
    18. Haber tomado cualquiera de las sustancias siguientes durante las cuatro semanas previas a la aleatorización:
    • Inhibidores de la colinesterasa o fármacos colinérgicos (por ej., rivastigmina, donepezil, tacrina, galantamina, relajantes musculares tipo succinilcholina). Se permitirá el uso de pilocarpina tópica.
    • Fármacos anticolinérgicos de acción central incluidos los antidepresivos tricíclicos y tetracíclicos
    • Neurolépticos distintos a la clozapina o la quetiapina
    • litio, paroxetina, memantina
    • Un fármaco en investigación
    • Un fármaco o tratamiento que se conozca que causa toxicidad del sistema orgánico principal
    19. Haber empezado a tomar cualquier fármaco nuevo, o modificado su dosis, durante las cuatro semanas previas a la aleatorización:
    • Medicación psicotrópica (clozapina, quetiapina, antidepresivos, ansiolíticos o hipnóticos incluidas las benzodiazepinas, anticonvulsivantes);
    • Medicación antiparkinsoniana;
    • Fármacos anticolinérgicos periféricos: Si una urgencia miccional o una incontinencia urinaria de novo constituyen un problema importante que no puede solventarse adecuadamente con medidas no farmacológicas, se permitirá iniciar el tratamiento con un fármaco anticolinérgico periférico como la tolterodina o la oxibutirina.
    E.5 End points
    E.5.1Primary end point(s)
    Analysis of the primary objective(s):
    - The two primary variables are:
    • the incidence rate of predefined AEs due to worsening of PD motor symptoms
    (tremor, muscle rigidity, bradykinesia, fall) in the Exelon® capsule group.
    • the discontinuation rate due, or potentially due, to predefined AEs due to worsening of PD motor symptoms (tremor, muscle rigidity, bradykinesia, fall) in the Exelon® capsule group.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Yes
    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 No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Information not present in EudraCT
    E.8.5.1Number of sites anticipated in the EEA90
    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
    N/A
    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 months7
    E.8.9.1In the Member State concerned days7
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days7
    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 No
    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
    Parkinson's disease dementia patients. Please see Inclusion Criteria No 10.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 408
    F.4.2.2In the whole clinical trial 550
    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 Decision2008-02-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-11-02
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