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    Summary
    EudraCT Number:2012-002840-26
    Sponsor's Protocol Code Number:PD0005
    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:2012-11-29
    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 number2012-002840-26
    A.3Full title of the trial
    A Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood
    PROTOCOLO PD0005
    ESTUDIO MULTICÉNTRICO, MULTINACIONAL, DOBLE CIEGO, CONTROLADO CON PLACEBO, DE TRES GRUPOS, DE FASE 4, PARA EVALUAR LA EFICACIA DE LA ROTIGOTINA EN LA APATÍA, LOS SÍNTOMAS MOTORES Y EL ESTADO DE ÁNIMO ASOCIADOS CON LA ENFERMEDAD DE PARKINSON
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's Disease
    Estudio para evaluar la eficacia de dos dosis de rotigotina en el estado de ánimo depresivo (apatía) asociado con la enfermedad de Parkinson
    A.4.1Sponsor's protocol code numberPD0005
    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 SponsorUCB Biosciences GmbH
    B.1.3.4CountryGermany
    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 supportUCB Biosciences GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB Biosciences GmbH
    B.5.2Functional name of contact pointAstrid Meyer
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Strasse 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.4Telephone number+492173481107
    B.5.5Fax number+492173481608
    B.5.6E-mailAstrid.Meyer@ucb.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Neupro
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Manufacturing Ireland 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.3.1Product nameRotigotine
    D.3.4Pharmaceutical form Transdermal patch
    D.3.4.1Specific paediatric formulation No
    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 INNROTIGOTINE
    D.3.9.1CAS number 99755-59-6
    D.3.9.4EV Substance CodeSUB21254
    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) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.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 Neupro
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Manufacturing Ireland 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.3.1Product nameRotigotine
    D.3.4Pharmaceutical form Transdermal patch
    D.3.4.1Specific paediatric formulation No
    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 INNROTIGOTINE
    D.3.9.1CAS number 99755-59-6
    D.3.9.4EV Substance CodeSUB21254
    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) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.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 Neupro
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Manufacturing Ireland 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.3.1Product nameRotigotine
    D.3.4Pharmaceutical form Transdermal patch
    D.3.4.1Specific paediatric formulation No
    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 INNROTIGOTINE
    D.3.9.1CAS number 99755-59-6
    D.3.9.4EV Substance CodeSUB21254
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number13.5
    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) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.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 Neupro
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Manufacturing Ireland 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.3.1Product nameRotigotine
    D.3.4Pharmaceutical form Transdermal patch
    D.3.4.1Specific paediatric formulation No
    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 INNROTIGOTINE
    D.3.9.1CAS number 99755-59-6
    D.3.9.4EV Substance CodeSUB21254
    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) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTransdermal patch
    D.8.4Route of administration of the placeboTransdermal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Parkinson's disease
    Enfermedad de Parkinson
    E.1.1.1Medical condition in easily understood language
    Degenerative disease of the nervous system
    Enfermedades degenerativas del sistema nervioso
    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 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
    To assess the effects of rotigotine over placebo on improvement of apathy and motor symptoms in subjects with early-stage and advanced stage idiopathic Parkinson?s disease
    Evaluar los efectos de la rotigotina frente al placebo en la mejoría de la apatía y los síntomas motores de los pacientes en las etapas tempranas y avanzadas de la enfermedad de Parkinson idiopática
    E.2.2Secondary objectives of the trial
    To evaluate the change in quality of life, anhedonia, depressive symptoms, fatigue, cognitive impairment, apathy rated by the caregiver, safety, and tolerability in subjects with apathy in early-stage and advanced-stage idiopathic Parkinson?s disease
    Evaluar el cambio en la calidad de vida, anhedonia, síntomas depresivos, fatiga, discapacidad cognitiva, apatía según el cuidador, seguridad y tolerabilidad de la rotigotina para pacientes en las etapas tempranas y avanzadas de la enfermedad de Parkinson idiopática.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject.
    2. Subject is considered reliable and capable of adhering to the protocol, visit schedule or medication application according to the judgment of the investigator.
    3. Subject is male or female and ? 18 years old at the Screening Visit.
    4. Subject has idiopathic Parkinson?s disease, defined by the cardinal sign, bradykinesia, plus the presence of at least 1 of the following: resting tremor, rigidity, or impairment of postural reflexes, and without any other known or suspected cause of Parkinsonism.
    5. Subject has unsatisfactory control of Parkinson?s disease motor symptoms under the current treatment, according to the judgment of the investigator.
    6. Subject has a Hoehn and Yahr stage score I-IV during the ?on? state at the Screening Visit.
    7. If subject is taking levodopa, he/she must be on a stable dose of levodopa (in combination with benserazide or carbidopa) for at least 28 days prior to the Baseline Visit, and the dose is expected to be maintained for the duration of the study.
    8. Subject suffers from apathy associated with Parkinson?s disease for at least 3 months, evidenced by a score of ? 2 on UPDRS Part I Item 4 at the Screening Visit and an average of at least ? 14 on the AS at the Screening and Baseline Visit as rated by the subject.
    9. Subject has a Mini-Mental State Examination (MMSE) score ? 25 at the Screening Visit.
    10. If the subject is receiving an anticholinergic agent, a monoamine oxidase (MAO) B-inhibitor, the Catechol-O-Methyl Transferase (COMT) inhibitor entacapone, or the N Methyl D Aspartate (NMDA) antagonist amantadine, he/she must have been on a stable dose for at least 28 days prior to the Baseline Visit, and the dose is expected to be maintained for the duration of the study.
    11. If subject is taking an antidepressant drug, such as selective serotonin reuptake inhibitors (SSRIs), serotonin?norepinephrine reuptake inhibitors (SNRIs), bupropion, or tricyclic antidepressants (TCAs), he/she must have been on a stable dose for at least 28 days prior to the Baseline Visit, and the dose is expected to be maintained for the duration of the study.
    12. Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (either oral/parenteral/implantable hormonal contraceptives, intrauterine device, or barrier and spermicide). Abstinence only is not an acceptable method. Subjects must agree to use adequate contraception during the study and for 4 weeks after their final dose of rotigotine (or longer, if required by local regulations).
    1. El paciente debe firmar y fechar un formulario de consentimiento informado por escrito aprobado por un Comité ético de investigación clínica (CEIC).
    2. Se considera que el paciente es responsable y capaz de adherirse al protocolo, al programa de visitas o a la aplicación del medicamento, a juicio del investigador.
    3. El paciente es un hombre o una mujer y ? 18 años de edad en la visita de selección.
    4. El paciente padece la enfermedad de Parkinson idiopática, definida por el síntoma esencial, bradiquinesia, más la presencia de al menos 1 de los siguientes síntomas: temblores en descanso, rigidez o inestabilidad de los reflejos posturales, y sin alguna de las otras causas conocidas o sospechadas del Parkinson.
    5. El paciente tiene un control no satisfactorio de los síntomas motores de la enfermedad de Parkinson con el tratamiento actual, a juicio del investigador.
    6. El paciente tiene una puntuación de etapa I a IV en el Hoehn y Yahr durante el estado ?activo? en la visita de selección.
    7. Si el paciente está tomando levodopa, debe estar tomando una dosis estable del mismo (en combinación con benserazida y carbidopa) durante al menos 28 días antes de la visita inicial, y es de esperar que la dosis se mantenga durante el resto del estudio.
    8. El paciente sufre apatía asociada a la enfermedad de Parkinson durante al menos 3 meses, demostrado por una puntuación ? 2 en la parte I, ítem 4 de la UPDRS en la visita de selección, y una media de al menos ? 14 en la EA según el paciente en las visitas de selección e inicial.
    9. El paciente tiene una puntuación de ? 25 en la mini prueba del estado mental (MMSE) en la visita de selección.
    10. Si el paciente está recibiendo un agente anticolinérgico, un inhibidor de la monoaminooxidasa (MAO) tipo B, el inhibidor de la catecol-O-metiltransferasa (COMT) entacapona, o el antagonista del N-metil-D-aspartato (NMDA) amantadina, debe haber estado tomando una dosis estable durante al menos 28 días antes de la visita inicial, y se espera que la dosis se mantenga durante el resto del estudio.
    11. Si el paciente está tomando un fármaco antidepresivo, como un inhibidor selectivo de recaptación de serotonina, inhibidor selectivo de recaptación de serotonina-norepinefrina, bupropión, o antidepresivos tricíclicos, debe haber estado tomando una dosis estable durante al menos 28 días antes de la visita inicial, y se espera que la dosis se mantenga durante el resto del estudio.
    12. Las pacientes deben haber estado en la etapa posmenopáusica durante al menos 1 año, ser quirúrgicamente incapaces de concebir o practicar eficazmente un método aceptable de anticoncepción (oral, parenteral, anticonceptivos hormonales implantables, dispositivo intrauterino o de barrera y espermicida). La abstinencia solamente no es un método aceptable. Los pacientes deben aceptar el uso de un método anticonceptivo apropiado durante el estudio y durante 4 semanas tras la dosis final de rotigotina (o más tiempo si lo requieren las normativas locales).
    E.4Principal exclusion criteria
    1. Subject has previously participated in this study or subject has previously been assigned to treatment in a study of the medication under investigation in this study.
    2. Subject has participated in another study of an investigational medicinal product (IMP) or a medical device within the last 28 days prior to the Screening Visit or is currently participating in another study of an IMP or a medical device.
    3. Subject has had prior therapy with a dopamine agonist within 28 days prior to the Baseline Visit.
    4. Subject discontinued from previous therapy with a dopamine agonist after an adequate length of treatment, at an adequate dose, due to lack of efficacy as assessed by the investigator.
    5. Subject has a history of chronic alcohol or drug abuse within the last 6 months.
    6. Subject has any medical or psychiatric condition (ie, bipolar disorder, dementia, hallucinations, or psychosis) that, in the opinion of the investigator, could jeopardize or would compromise the subject?s ability to participate in this study.
    7. Subject has received neuroleptics (except clozapine and quetiapine), dopamine releasing substances (eg, methylphenidate or amphetamine), dopamine modulating substances (eg, reserpine), alpha-methyldopa, metoclopramide, MAO-A inhibitors, budipine, or tolcapone within 28 days of the Baseline Visit.
    8. Subject has received electroconvulsive therapy within 12 weeks prior to the Screening Visit.
    9. Subject is receiving current psychotherapy or behavior therapy while participating in this study.
    10. Subject has a history of deep brain stimulation.
    11. Subject has a known hypersensitivity to any components of the IMP or comparative drugs as stated in the protocol.
    12. Subject has a significant skin disease that would make transdermal drug use inappropriate, including a history of skin sensitivity to adhesives or transdermal medications.
    13. Subject has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response (?Yes?) to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at the Screening Visit.
    14. Subject has an atypical Parkinson?s disease syndrome due to drugs (eg, neuroleptics, metoclopramide, flunarizine), metabolic neurogenetic disorders (eg, Wilson Disease), encephalitis, cerebrovascular disease, or degenerative diseases (progressive supranuclear palsy).
    15. Subject has evidence of an impulse control disorder (ICD) according to the modified Minnesota Impulsive Disorders Interview (mMIDI) at the Screening Visit confirmed by a positive structured clinical interview.
    16. Subject who is currently lactating or pregnant or planning to become pregnant during the duration of the study.
    17. Subject diagnosed with severe depression as evidenced by a BDI-II score of ?29 at the Screening Visit.
    18. Subject has symptomatic orthostatic hypotension at Screening.
    1. El paciente ha participado anteriormente en este estudio o ha sido asignado anteriormente a algún tratamiento en un estudio del medicamento que se investiga en este estudio.
    2. El paciente ha participado en otro estudio de un medicamento en investigación (PEI) o dispositivo médico en los últimos 28 días antes de la visita de selección o está participando actualmente en otro estudio de un PEI o dispositivo médico.
    3. El paciente ha recibido anteriormente una terapia con un agonista de la dopamina en los 28 días anteriores a la visita inicial.
    4. El paciente interrumpió una terapia anterior con un agonista de la dopamina después de una duración adecuada del tratamiento, a una dosis apropiada, debido a la carencia de eficacia según la valoración del investigador.
    5. El paciente tiene antecedentes de abuso de alcohol o drogas crónico en los últimos 6 meses.
    6. El paciente tiene alguna afección médica o psiquiátrica (por ejemplo, trastorno bipolar, demencia, alucinaciones o psicosis) que, en opinión del investigador, podría hacer peligrar o comprometer la capacidad del paciente para participar en este estudio.
    7. El paciente ha recibido neurolépticos (excepto clozapina y quetiapina), sustancias liberadoras de la dopamina (p. ej., metilfenidato o anfetamina), sustancias moduladoras de la dopamina (p. ej., reserpina), alfametildopa, metoclopramida, inhibidores MAO tipo A, budipina o tolcapona durante los 28 días anteriores a la visita inicial.
    8. El paciente ha recibido terapia electroconvulsiva durante las 12 semanas anteriores a la visita de selección.
    9. El paciente está recibiendo actualmente psicoterapia o terapia de comportamiento mientras participa en este estudio.
    10. El paciente tiene antecedentes de estimulación cerebral profunda.
    11. El paciente tiene una hipersensibilidad conocida a algún componente del PEI o de los fármacos de comparación, según se establece en el protocolo.
    12. El paciente tiene una enfermedad cutánea significativa que haría inadecuado el uso de fármacos transdérmicos, incluso antecedentes de sensibilidad de la piel a los adhesivos o a medicamentos transdérmicos.
    13. El paciente tiene antecedentes de intento de suicidio (incluidos un intento real, un intento interrumpido o un intento fracasado), o ha tenido pensamientos suicidas en los últimos 6 meses como lo indicaría una respuesta positiva (?Sí?) a la pregunta 4 o a la pregunta 5 de la escala de Columbia para evaluar la gravedad de las conductas suicidas (C-SSRS) en la visita de selección.
    14. El paciente tiene un síndrome atípico de la enfermedad de Parkinson debido a fármacos (p. ej., neurolépticos, metoclopramida, flunarizina), trastornos neurogenéticos metabólicos (p. ej., enfermedad de Wilson), encefalitis, enfermedades cerebrovasculares o degenerativas (parálisis supranuclear progresiva).
    15. El paciente muestra señales de un trastorno de control de impulsos (TCI) según la entrevista de trastornos impulsivos de Minnesota (mMIDI) en la visita de selección confirmado por una entrevista clínica estructurada positiva.
    16. La paciente que está amamantando o embarazada o planea un embarazo durante el curso del estudio.
    17. Se ha diagnosticado al paciente depresión grave como queda demostrado por una puntuación de ? 29 en BDI-II en la visita de selección.
    18. El paciente tiene hipotensión ortostática sintomática en la selección.
    E.5 End points
    E.5.1Primary end point(s)
    ? Change from Baseline to the end of Maintenance Period in the score of the AS rated by the subject
    ? Change from Baseline to the end of Maintenance Period in the total score of the UPDRS Parts II (ADL) + III (motor subscale)
    - Cambio desde el momento basal hasta el fin del periodo de mantenimiento en la puntuación de la EA según el paciente
    - Cambio desde el momento basal hasta el fin del periodo de mantenimiento en la puntuación total de la parte II (AVD) y la parte III (subescala motora) de la UPDRS
    E.5.1.1Timepoint(s) of evaluation of this end point
    Following titration (up to 7 weeks) and maintainance (12 weeks) periods, up to 19 weeks total
    Tras el periodo de ajuste de dosis(de un máximo de 7 semanas) y de mantenimiento (12 semanas), hasta un máximo de 19 semanas en total
    E.5.2Secondary end point(s)
    ? Change from Baseline to the end of Maintenance Period in the score of the AS rated by the caregiver (where available)
    ? Change from Baseline to the end of Maintenance Period in the sum score of the 8-item Parkinson?s Disease Questionnaire (PDQ-8)
    ? Change from Baseline to the end of Maintenance Period in the sum score of domain mood/apathy of the NMSS
    ? Change from Baseline to the end of Maintenance Period in the sum score of the Snaith Hamilton Pleasure Scale (SHAPS)
    ? Change from Baseline to the end of Maintenance Period in the sum score of the Beck Depression Inventory (BDI-II)
    ? Change from Baseline to the end of Maintenance Period in the sum score of the UPDRS Part III (motor subscale) in ?on? state
    ? Change from Baseline to the end of Maintenance Period in the score of the Clinical Global Impressions (CGI) Item I (Severity of Illness)
    ? Cambio desde el inicio hasta el fin del periodo de mantenimiento en la puntuación de la EA según el cuidador (donde esté disponible)
    ? Cambio desde el inicio hasta el fin del periodo de mantenimiento en la suma de la puntuación del cuestionario de 8 ítems para la enfermedad de Parkinson (PDQ-8)
    ? Cambio desde el inicio hasta el fin del periodo de mantenimiento en la suma de la puntuación del dominio ánimo/cognición de la NMSS
    ? Cambio desde el inicio hasta el fin del periodo de mantenimiento en la suma de la puntuación de la escala de placer de Snaith-Hamilton (SHAPS)
    ? Cambio desde el inicio hasta el fin del periodo de mantenimiento en la suma de la puntuación del inventario para la depresión de Beck, segunda edición (BDI-II)
    ? Cambio desde el inicio hasta el fin del periodo de mantenimiento en la suma de la puntuación de la parte III (subescala motora) de la UPDRS en el estado ?activo?
    ? Cambio desde el inicio hasta el fin del periodo de mantenimiento en la puntuación del ítem I (gravedad de la enfermedad) de las impresiones clínicas globales (ICG)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Following titration (up to 7 weeks) and maintainance (12 weeks) periods, up to 19 weeks total
    Tras el periodo de ajuste de dosis(de un máximo de 7 semanas) y de mantenimiento (12 semanas), hasta un máximo de 19 semanas en total
    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 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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA61
    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
    Austria
    Bulgaria
    Croatia
    Hungary
    Italy
    Poland
    Romania
    Serbia
    Slovakia
    Slovenia
    Spain
    Turkey
    Ukraine
    United States
    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
    LVLS
    UPUV
    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 months8
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days10
    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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state54
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 210
    F.4.2.2In the whole clinical trial 504
    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)
    Following final visit, subjects will return to standard of care treatment
    as defined by their regular physician
    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 Decision2013-01-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-11
    P. End of Trial
    P.End of Trial StatusCompleted
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