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    Summary
    EudraCT Number:2016-001575-71
    Sponsor's Protocol Code Number:B7601011
    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:2017-01-17
    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 number2016-001575-71
    A.3Full title of the trial
    A 15 WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO CONTROLLED, FLEXIBLE DOSE STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH EARLY STAGE PARKINSON’S DISEASE
    ESTUDIO DE FASE II, ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO Y CON ADMINISTRACIÓN FLEXIBLE DURANTE 15 SEMANAS PARA ESTUDIAR LA EFICACIA, SEGURIDAD Y TOLERABILIDAD DE PF 06649751 EN PACIENTES CON ENFERMEDAD DE PARKINSON EN ESTADIO INICIAL
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 15-WEEK CLINICAL STUDY TO DETERMINE THE EFFECTIVENESS, SAFETY AND TOLERABILITY OF PF-06649751 IN PATIENTS WITH EARLY PARKINSON’S DISEASE
    ESTUDIO CLINICO DE 15 SEMANAS DE DURACION PARA DETERMINAR LA EFICACIA, SEGURIDAD Y TOLERABILIDAD DE PF 06649751 EN PACIENTES CON ENFERMEDAD DE PARKINSON EN ESTADIO INICIAL
    A.4.1Sponsor's protocol code numberB7601011
    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 SponsorPfizer, Inc.
    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 supportPfizer, Inc
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Centre
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017,
    B.5.3.4CountryUnited States
    B.5.4Telephone number18007181021
    B.5.6E-mailClinicalTrials.gov_Inquiries@pfizer.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 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 namePF-06649751
    D.3.2Product code PF-06649751
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPF-06649751
    D.3.9.2Current sponsor codePF-06649751
    D.3.9.3Other descriptive namePF-06649751
    D.3.9.4EV Substance CodeSUB178413
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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 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 namePF-06649751
    D.3.2Product code PF-06649751
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPF-06649751
    D.3.9.2Current sponsor codePF-06649751
    D.3.9.3Other descriptive namePF-06649751
    D.3.9.4EV Substance CodeSUB178413
    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) 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 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 namePF-06649751
    D.3.2Product code PF-06649751
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPF-06649751
    D.3.9.2Current sponsor codePF-06649751
    D.3.9.3Other descriptive namePF-06649751
    D.3.9.4EV Substance CodeSUB178413
    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) 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 placeboTablet
    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
    Parkinson's Disease
    Enfermedad de Parkison
    E.1.1.1Medical condition in easily understood language
    Gradually developing disorder of the nervous system that affects movement.
    Desarrollo gradual de un desorden del sistema nervioso que afecta al movimiento
    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 19.1
    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 evaluate the effect of PF 06649751 administered once daily on motor symptoms in subjects with early stage Parkinson’s disease.
    Evaluar el efecto de PF06649751 administrado diariamente en los síntomas motores en pacientes con enfermedad de Parkison en estadio inicial
    E.2.2Secondary objectives of the trial
    - To evaluate the safety and tolerability of PF 06649751 administered once daily in subjects with early stage Parkinson’s disease.
    - To evaluate the effect of PF 06649751 administered once daily on other domains relevant in early Parkinson’s disease (eg, depression, daytime sleepiness, and cognition).
    - To characterize steady state plasma concentrations of PF 06649751.
    - To explore the relationship between PF 06649751 plasma exposures and relevant study endpoints.
    - Pooled or exploratory analyses, if conducted, utilizing the biobanked exploratory genomic and biomarker samples across PF 06649751 studies or across multiple programs will be documented in a separate protocol and/or statistical analysis plan.
    •Evaluar la seguridad y tolerabilidad de PF-06649751 administrado una vez al día en pacientes con enfermedad de Parkinson en fase temprana.
    •Evaluar el efecto de PF-06649751 administrado una vez al día en otras áreas de interés de la enfermedad de Parkinson en fase temprana (p. ej., depresión, somnolencia diurna y cognición).
    •Caracterizar las concentraciones plasmáticas en situación de equilibrio de PF-06649751.
    •Estudiar la relación entre las exposiciones plasmáticas de PF-06649751 y los criterios de valoración del estudio pertinentes.
    •Los análisis agrupados o exploratorios, si es que se llevan a cabo, en los que se utilicen muestras genómicas y de biomarcadores exploratorios conservadas en biobancos de todos los estudios con PF-06649751 o de diversos programas, se documentarán en un protocolo y/o plan de análisis estadístico independiente.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
    2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    3. Females of non childbearing potential and/or male subjects between the ages of 45 and 80 years, inclusive.
    4. Male subjects able to father children must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment.
    5. Female subjects of non childbearing potential (ie, meet at least 1 of the following criteria):
    - Have undergone a documented hysterectomy and/or bilateral oophorectomy;
    - Have medically confirmed ovarian failure; or
    - Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle stimulating hormone (FSH) level confirming the post menopausal state.
    6. Clinical diagnosis of Parkinson’s disease consistent with the United Kingdom (UK) Parkinson’s Disease Society Brain Bank Clinical Diagnostic Criteria (Appendix 4).
    7. Parkinson’s Disease Hoehn & Yahr Stage I III inclusive.
    8. Parkinson’s disease subjects deemed appropriate for treatment of motor symptoms with a MDS UPDRS Part III score >=10.
    9. Treatment naïve or history of prior incidental treatment with dopaminergic agents (including L Dopa and dopamine receptor agonist medications) for no more than 28 days and not within at least 7 days prior to Visit 1 (Randomization) as outlined in Section 5.8, Concomitant Treatment(s), and Appendix 2 in the protocol.
    10. Willing and able to refrain from any Parkinson’s disease medication not permitted by the protocol (including dopaminergic agents) throughout participation in the study as outlined in Appendix 2 in the protocol.
    11. A score of >=26 on the Mini Mental State Examination (MMSE).
    12. Body Mass Index (BMI) of 17.5 to 35 kg/m2; and a total body weight >= 45 kg.
    1. Evidencia de que el paciente ha firmado HIP/CI, indicando que el paciente ha sido informado en todos los aspectos del estudio.
    2. Pacientes que son capaces de cumplir con las visitas del estudio, con el tratamiento, con los analíticas sanguineas y otros procedimientos.
    3. Mujeres no embarazadas y hombres entre 45-80 años de edad, ambos incluidos.
    4. Hombres que pudieran ser padres deben de estar de acuerdo en utilizar un método anticonceptivo efectivo durante el estudio y al menos 28 días después de la última dosis de tratamiento.
    5. Mujeres que potencialmente no pueden quedarse embarazadas (que cumplan al menos uno de los siguientes criterios):
    -presentan una histerectomia documentada y/o ooferoctmia bilateral.
    -confirmado fallo ovárico, o
    -que presenta estado postmenopáusico, definido como: no presencia de menstruación en al menos 12 meses consecutivos sin causa alternativa patológica o fisiológica; confirmado el estado postmenospáusico según los niveles de hormona foliculoestimulante.
    6. Diagnóstico clínico de la enfermedad de Parkison consistente con el criterio de diagnóstico del banco cerebral de la sociedad de Parkison de UK (apéndice 4).
    7. Estado Hoehn & Yahr I y II ambos incluidos de la enfermedad de parkison.
    8. Pacientes con parkison que presentan un tratamiento adecuado para los síntomas motores con "MDS UPDRS" parte III con un valor >=10.
    9. Pacientes no tratados o historia previa de tratamiento causal con dopanérgicos (incluyendo L dopa y medicamentos antagonistas del receptor de dopamina) durante no mas de 28 días y no durante al menos 7 días antes de la visita 1 (aleatorización) como se indica en la sección 5.8, tratamiento concomitante y en el apéndice 2 del protocolo.
    10. Paciente capz y dispuesto a abstenerse de medicaciones no permitidas para el parkison según protocolo (incluyendo agentes dopanérgicos) durante la participación en el estudio tal y como se indica en el apéndice 2 del protocolo.
    11. Calificación de >=26 para el examen del estado mínimo mental.
    12. Indice de masa corporal de 17.5 a 35 kg/m2; y con un peso corporal de >=45 kg.
    E.4Principal exclusion criteria
    1. History or clinical features consistent with an atypical Parkinsonian syndrome (including but not limited to Progressive Supranuclear Palsy, Multiple System Atrophy, Cortico Basal Degeneration, etc).
    2. Any Parkinson’s disease related feature or symptom that could interfere with the study conduct and results as assessed by the sponsor or Investigator.
    3. Presence of acute or chronic clinically significant medical, including fever, or psychiatric condition or cognitive impairment or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
    4. Presence or history of brain tumor, past history of hospitalization for head trauma with loss of consciousness, epilepsy (as defined by the International League Against Epilepsy)E31, including childhood seizures, or conditions that lower seizure threshold, seizures of any etiology (including substance or drug withdrawal), or known increased risk of seizures.
    5. Any significant AXIS I psychiatric disease as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition Revised (DSM IV TR, American Psychiatric Association, 2000) including subjects with clinically significant depression (PHQ 8 total score >=15) (refer to Section 7.1.6 of the protocol, Depression Assessment (PHQ 8). Presence of minor depression or treated, stable depressive disorder is acceptable.
    6. Subjects who have made a suicide attempt within the last 5 years. Subjects who, in the investigator’s judgment, pose a significant suicide risk. Subjects who have suicidal ideation associated with actual intent and a method or plan in the past 6 months (ie, “Yes” answers on items 4 or 5 of the C-SSRS; refer to Section 7.3 Assessment of Suicidal Ideation and Behavior (C-SSRS).
    7. History of clinically significant alcohol or substance dependency (other than caffeine or nicotine), as defined in DSM IV TR, within 1 year before Screening.
    8. In the opinion of the investigator (or caregiver, as applicable), has signs/symptoms suggestive of clinically significant cognitive impairment that would interfere with the ability to comply with study procedures.
    9. Any condition possibly affecting drug absorption, past surgery of the gastrointestinal tract (eg, gastrectomy, colectomy), except cholecystectomy.
    10. History of vasculitis.
    11. History of Human Immunodeficiency Virus (HIV) infection.
    12. History of malignancy other than:
    • Non-metastatic basal or squamous cell carcinoma of the skin or carcinoma in situ that was surgically removed in total >1 year before screening and has not recurred.
    • Other type of malignancy which has been in remission 5 years or more before screening and has not recurred.
    13. Subjects with first degree family history of unexplained sudden death, or of Long QT syndrome (LQTS).
    14. Within 1 year of Screening or between Screening and Visit 1 (Randomization), any of the following: myocardial infarction; moderate or severe congestive heart failure, NYHA class III or IV; hospitalization for, or symptoms of, unstable angina; syncope due to orthostatic hypotension or unexplained syncope; known significant structural heart disease (eg, significant valvular disease, hypertrophic cardiomyopathy); or hospitalization for arrhythmia.
    15. Currently receiving moderate or strong CYP3A4 inducers or CYP3A4 inhibitors (except for topical administration) as outlined in Section 5.8 Concomitant Treatment(s), Appendix 2, and Appendix 3.
    16. Currently receiving an antipsychotic, metoclopramide, reserpine, or amphetamine as outlined in Section 5.8 Concomitant Treatment(s) and Appendix 2.
    17. Prohibited concomitant medications as outlined in Section 5.8, Concomitant Treatment(s), and Appendix 2.
    18. Pregnant female subjects; breastfeeding female subjects; females of childbearing potential (assessed at Screening); male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product or longer based upon the compound’s half life characteristics.
    19. Screening supine blood pressure >=160 mm Hg (systolic) or >=95 mm Hg (diastolic), on a single measurement. If abnormal, up to 2 repeats are permitted following at least 5 minutes of rest. The screening value in that case will be the average of the 2 values closest to the normal range.

    Please refer to the study protocol for full list of exclusion criteria
    1. Historia o característica clínicas consisitentes con el síndrome atípico de parkison (incluyendo pero no limitado con parálisis supranuclear progresiva, atrofia múltiple sistémica, degeneración basal cortical, etc).
    2. Alguna enfermedad con caracteríticas relacionadas al parkison o síntomas que pudieran interferir con la realización del estudio y resultados evaluados por el promotor o por el investigador.
    3. Presencia de caracteríticas médicas clínicamente agudas or crónicas, incluyendo fiebre o condiciones psiquiátricas o deficiencia cognitiva o abnormalidades sanguíneas que pudieran incrementar el riesgo asociado con la participación en el estudio o con el medicamento de estudio administrado o pudieran interferir con la interpretación de los resultados del estudio, con la opinión del investigador, podrían hacer que el paciente no sea el adecuado para entrar en el estudio.
    4. Presencia o historia de tumor cerebral, historia pasada de hospitalización por trauma de cabeza con pérdida de consciencia, epilepsia (definida por la liga internacional contra la epilepsia) E31, incluyendo temblores infantiles, o condiciones de umbral bajo de convulsión, convulsión debida a cualquier etiología (inlcuyendo eliminacióm de alguna sustancia o droga) o aumento de riesgo conocido de convulsiones.
    5. Cualquier enfermedad psiquiátrica significativa del AXIS I definida en el Manual Diagnóstico y Estadístico de Trastornos Mentales, 4ª Edición Revisada (DSM IV TR, Asociación Psiquiátrica Americana, 2000) incluyendo sujetos con depresión clínicamente significativa (puntuación total de PHQ 8> = 15). Consulte la Sección 7.1.6 del protocolo Evaluación de la Depresión (PHQ 8). Presencia de depresión leve o trastorno depresivo estable y tratado es aceptable.
    6. Sujetos que han tenido un intento de suicidio en los últimos 5 años. Sujetos que, a juicio del investigador, plantean un riesgo significativo de suicidio. Los sujetos que tienen ideas suicidas asociada con la intención real y un método o plan en los últimos 6 meses (es decir, "Sí" responde en los puntos 4 o 5 de la C-SSRS, consulte la Sección 7.3 Evaluación de Ideación Suicida y Comportamiento (C- SSRS).
    7. Antecedentes de dependencia de alcohol o sustancias clínicamente significativas (que no sean la cafeína o la nicotina), según se define en DSM IV TR, dentro de un año antes de la selección.
    8. En opinión del investigador (o cuidador, según corresponda), tiene signos / síntomas sugestivos de deterioro cognitivo clínicamente significativo que interfieran con la capacidad de cumplir con los procedimientos del estudio.
    9. Cualquier condición que posiblemente afecte la absorción del fármaco, cirugía anterior del tracto gastrointestinal (por ejemplo, gastrectomía, colectomía), excepto la colecistectomía.
    10. Historia de vasculitis.
    11. Historia de la infección por el virus de la inmunodeficiencia humana (VIH).
    12. Historial de malignidad que no sea:
    • Carcinoma basocelular o escamoso no metastásico de la piel o carcinoma in situ que fue extirpado quirúrgicamente en su totalidad > 1 año antes del cribado y no ha vuelto a ocurrir.
    • Otro tipo de neoplasia maligna que ha estado en remisión 5 años o más antes del cribado y no ha recidivado.
    13. Sujetos con antecedentes familiares de primer grado de muerte súbita inexplicable o síndrome de QT largo (SQTL).
    14. Durante el año anterior a la selección o entre la selección y la visita 1 (aleatorización), cualquiera de los siguientes: infarto de miocardio; Insuficiencia cardiaca congestiva moderada o severa, clase III o IV de la NYHA; Hospitalización o síntomas de angina inestable; Síncope debido a hipotensión ortostática o síncope inexplicado; Enfermedad cardíaca estructural significativa conocida (p. Ej., Enfermedad valvular significativa, cardiomiopatía hipertrófica); u hospitalización por arritmia.
    15. Actualmente está recibiendo inductores moderados o fuertes de CYP3A4 o inhibidores de CYP3A4 (excepto para administración tópica) como se describe en la Sección 5.8 Tratamiento (s) concomitante, Apéndice 2 y Apéndice 3.
    16. Recibiendo actualmente un antipsicótico, metoclopramida, reserpina o anfetamina como se describe en la Sección 5.8 Tratamiento (s) concomitante y Apéndice 2.
    17. Medicamentos concomitantes prohibidos como se describe en la Sección 5.8, Tratamiento (s) concomitante y Apéndice 2.
    18. Mujeres embarazadas; Lactancia materna; Mujeres en edad fértil; Sujetos masculinos con parejas actualmente embarazadas; Sujetos masculinos capaces de tener hijos que no usen anticonceptivo durante el estudio y 28 días después de la última dosis.
    19. Que durante la visita de preselección presente una presión arterial supina> = 160 mm Hg (sistólica) o> = 95 mm Hg (diastólica), en una sola medición.
    Por favor, refiérase la lista completa de criterios de exclusión del protocolo del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    (Efficacy) Change from baseline in the Modified Unified Parkinson’s Disease Rating Scale (MDS UPDRS) Score Part III
    (Eficacia) Cambio desde la línea basal de la Escala de Evaluación de la Enfermedad de Parkinson Unificada Modificada ("MDS UPDRS") Puntuación Parte III
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 15
    Semana 15
    E.5.2Secondary end point(s)
    (Safety and Tolerability)
    - Adverse events.
    - Clinical laboratory parameters.
    - Vital signs.
    - Electrocardiogram (ECG) parameters.
    - Columbia Suicide Severity Rating Scale (C-SSRS).
    - Questionnaire for Impulsive Compulsive Disorders in Parkinson’s Disease – Rating Scale (QUIP RS).
    - Physician Withdrawal Checklist (PWC 20).

    (Exploratory endpoints)
    - Beck Depression Inventory – II (BDI II).
    - Epworth Sleepiness Scale (ESS).
    - Patient Global Impression Severity (PGI S).
    - Patient Global Impression – Improvement (PGI I).
    - Parkinson’s Disease Questionnaire (PDQ 39).
    - EuroQol 5 Dimension (EQ 5D 5L).
    - Oral Symbol Digit Modality Test.
    - Modified Clinical Global Impression-Severity (MCGI S).
    - Modified Clinical Global Impression-Improvement (MCGI I).
    - MDS – UPDRS Part I.
    - MDS – UPDRS Part II.
    - MDS – UPDRS Parts II + III.
    - MDS – UPDRS Parts I + II + III.
    - MDS – UPDRS Total Score (Parts I + II + III + IV).
    - Average plasma PF-06649751 concentrations
    - Exploratory exposure response relationship with relevant endpoints.
    - Serum Prolactin level at Visit 14.
    - Banked biospecimens for possible follow up analysis.
    (Seguridad y Tolerabilidad)
    - Acontecimientos adversos.
    - Parámetros analíticos clínicos.
    - Constantes vitales.
    - Parámetros del electrocardiograma (ECG).
    - Escala Columbia de valoración del riesgo de suicidio (Columbia Suicide Severity Rating Scale, C-SSRS).
    - Cuestionario para los trastornos impulsivo-compulsivos en la enfermedad de Parkinson, escala de valoración (Questionnaire for Impulsive-Compulsive Disorders in Parkinson’s Disease–Rating Scale, QUIP-RS).
    - Lista de comprobación de retirada del médico (Physician Withdrawal Checklist, PWC-20).
    (Criterios de valoración exploratorios)
    -Inventario de depresión de Beck – II (Beck Depression Inventory-II, BDI-II).
    -Escala de somnolencia de Epworth (Epworth Sleepiness Scale, ESS).
    -Impresión global del paciente de la gravedad (Patient Global Impression-Severity, PGI-S).
    -Impresión global del paciente de la mejoría (Patient Global Impression-Improvement, PGI-I).
    -Cuestionario de la enfermedad de Parkinson (Parkinson’s Disease Questionnaire, PDQ-39).
    -EuroQoL 5 dimensiones (EQ-5D-5L).
    -Prueba de símbolos y dígitos, modalidad oral.
    -Impresión clínica global modificada de la gravedad (Modified Clinical Global Impression-Severity, MCGI-S).
    -Impresión clínica global modificada de la mejoría (Modified Clinical Global Impression, Improvement, MCGI-I).
    -MDS – UPDRS, parte I.
    -MDS – UPDRS, parte II.
    -MDS – UPDRS, partes II + III.
    -MDS – UPDRS, partes II + II + III.
    -MDS – UPDRS, puntuación total (partes I + II + III + IV).
    -Relación exploratoria entre la exposición-respuesta y los criterios de valoración pertinentes.
    -Nivel de prolactina en suero en la visita 14.
    -Muestras biológicas conservadas en bancos para posibles análisis de seguimiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety and tolerability endpoints are assessed throughout the course of the study

    Exploratory endpoints:
    - Change from baseline at Weeks 10 and 15: BDI II, ESS, PGI S, PGI I, PDQ 39, EQ 5D 5L, Symbol Digit Modality Test, MCGI S, MCGI I, MDS - UPDRS Part I and Part II, Parts II+III, Parts I+II+III, Total Score - Parts I+II+III+IV
    - PF-06649751 plasma concentrations - Visit 4, 6, 10, 12 and 14
    - Serum prolaction level
    Objetivos de seguridad y de tolerabilidad evaluados a través del curso del estudio.
    Objetivos exploratosio:
    - Cambios desde la basal hasta la semana 10 y 15: BDI II, ESS, PGI S, PGI I, PDQ 39, EQ 5D 5L, prueba de modalidad digital simbólica, MCGI S, MCGI I, MDS - UPDRS Parte I yParte II, Partes II+III, Partes I+II+III, Puntuación total- Partes I+II+III+IV
    - Concretaciones plasmáticas de PF-06649751- visitas 4, 6, 12, y 14
    - Niveles séricos de prolactina
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tolerabilidad
    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) 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.8.2.4Number of treatment arms in the trial2
    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 EEA13
    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
    France
    Germany
    Israel
    Spain
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LPLV
    Ultima visita del último paciente
    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 months0
    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 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 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: 53
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 26
    F.4.2.2In the whole clinical trial 88
    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)
    None.
    Ninguno
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation FCRIN NS-Park Network
    G.4.3.4Network Country France
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Studienzentrale Kompetenznetz Parkinson, Klinik für Neurologie
    G.4.3.4Network Country Germany
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation DupCheck Statistics, Ltd
    G.4.3.4Network Country Israel
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-01
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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