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    Summary
    EudraCT Number:2014-003739-20
    Sponsor's Protocol Code Number:ADS-AMT-PD302
    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:2015-02-16
    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 number2014-003739-20
    A.3Full title of the trial
    Open-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa-Induced Dyskinesia
    Estudio abierto sobre la seguridad de ADS-5102 (amantadina HCl) en cápsulas de liberación prolongada para el tratamiento de la discinesia inducida por la levodopa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to see if ADS-5102 is safe in people with drug induced abnormal movements in Parkinson's disease
    Un ensayo clínico para determinar si ADS- 5102 es segura y eficaz en personas con movimientos anormales inducidos por drogas en la enfermedad de Parkinson.
    A.4.1Sponsor's protocol code numberADS-AMT-PD302
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02202551
    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 SponsorAdamas Pharmaceuticals, 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 supportAdamas Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAdamas Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street Address1900 Powell Street, Suite 750
    B.5.3.2Town/ cityEmeryville
    B.5.3.3Post codeCA 94608
    B.5.3.4CountryUnited States
    B.5.4Telephone number900834223
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.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 nameAmantadine HCl Extended Release Capsule
    D.3.2Product code ADS-5102
    D.3.4Pharmaceutical form Prolonged-release capsule, hard
    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 INNAmantadine hydrochloride (HCl)
    D.3.9.1CAS number 665-66-7
    D.3.9.3Other descriptive nameAMANTADINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB00422MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number170
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of levodopa-induced dyskinesia in subjects with Parkinson's disease
    Tratamiento de pacientes con enfermedad de Parkinson con discinesia inducida por la Levodopa
    E.1.1.1Medical condition in easily understood language
    Treatment of drug induced abnormal movements in Parkinson's disease
    Tratamiento de movimientos anormales inducidos por drogas en la enfermedad de Parkinson
    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 18.0
    E.1.2Level PT
    E.1.2Classification code 10013916
    E.1.2Term Dyskinesia
    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 safety and tolerability of ADS-5102 oral capsules, an extended release formulation of amantadine, administered at a dose of 340 mg once nightly at bedtime for the treatment of levodopa induced dyskinesia (LID) in subjects with Parkinson?s disease (PD).
    Evaluar la seguridad y tolerabilidad de ADS-5102 cápsulas orales, una formulación de amantadina de liberación prolongada, administrada en una dosis de 340 mg todas las noches al acostarse, para el tratamiento de la discinesia inducida por la levodopa (DIL) en pacientes con enfermedad de Parkinson (EP).
    E.2.2Secondary objectives of the trial
    To evaluate duration of ADS-5102 effect on dyskinesia as assessed by the Unified Parkinson?s Disease Rating Scale (MDS-UPDRS), Part IV
    To evaluate clinical progression of Parkinson?s disease as assessed by MDS-UPDRS, Combined Score, Parts I, II, and III
    Evaluar la duración del efecto de ADS-5102 en la discinesia mediante la Escala unificada para la evaluación de la enfermedad de Parkinson (MDS-UPDRS), parte IV.
    Evaluar la progresión clínica de la enfermedad de Parkinson mediante la puntuación combinada de la escala MDS-UPDRS, partes I, II y III.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Group 1: Current Adamas LID study subjects
    Below are the inclusion criteria subjects who are continuing directly into ADS-AMT-PD302 without a time gap between their Adamas LID efficacy study and ADS-AMT-PD302:
    1. Signed a current IRB/REB/IEC-approved informed consent form
    2. Completed study visits per protocol in a previous Adamas efficacy study
    3. Ambulatory or ambulatory-aided (e.g. walker or cane) ability while ON, such that the subject can complete study assessments
    4. Knowledgeable and reliable caregiver/study partner, if appropriate, to accompany the subject to study visits and assist in completion of study assessments, as needed and allowed
    5. History of peak dose dyskinesia that might benefit from specific dyskinesia treatment in the judgment of the subject and clinical investigator
    6. On a stable regimen of antiparkinson?s medications, including a levodopa preparation administered not less than three times daily

    Group 2: Previous Adamas LID study subjects
    Below are the inclusion criteria for subjects who participated in a previous Adamas efficacy study evaluating ADS-5102 in LID and will enter ADS-AMT-PD302 with a time gap:
    1. Signed a current IRB/REB/IEC-approved informed consent form
    2. Completed study visits per protocol in a previous Adamas efficacy study
    3. Ambulatory or ambulatory-aided (e.g. walker or cane) ability while ON, such that the subject can complete study assessments
    4. Knowledgeable and reliable caregiver/study partner, if appropriate, to accompany the subject to study visits and assist in completion of study instruments, as needed and allowed
    5. Peak dose dyskinesia during Screening that might benefit from specific dyskinesia treatment in the judgment of the subject and clinical investigator OR a history of peak dose dyskinesia that is currently being managed by amantadine treatment
    6. On a stable regimen of antiparkinson?s medications at least 30 days prior to screening, including a levodopa preparation administered not less than three times daily
    7. Parkinson?s disease, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria

    Group 3: Non Adamas LID study subjects ? with prior DBS
    Below are the eligibility criteria for subjects who would have been deemed ineligible for participation in previous or current Adamas efficacy studies due to having undergone deep brain stimulation:
    1. Signed a current IRB/REB/IEC-approved informed consent form
    2. Subject has undergone deep brain stimulation procedure prior to start of this study (14 July 2014)
    3. Ambulatory or ambulatory-aided (e.g. walker or cane) ability while ON, such that the subject can complete study assessments
    4. Knowledgeable and reliable caregiver/study partner, if appropriate, to accompany the subject to study visits and assist in completion of study instruments, as needed and allowed
    5. Peak dose dyskinesia during Screening that might benefit from specific dyskinesia treatment in the judgment of the subject and clinical investigator OR a history of peak dose dyskinesia that is currently being managed by amantadine treatment
    6. On a stable regimen of antiparkinson?s medications at least 30 days prior to screening, including a levodopa preparation administered not less than three times daily
    7. Parkinson?s disease, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria
    Grupo 1: sujetos incluidos actualmente en un estudio Adamas sobre la DIL
    Seguidamente se describen los criterios de inclusión que deben cumplir los sujetos que se
    incorporen directamente al estudio ADS-AMT-PD302 sin dejar un intervalo entre el estudio
    Adamas de eficacia en la DIL y el ADS-AMT-PD302:
    1. Firma del documento de consentimiento informado aprobado por el CEIC.
    2. Realización de las visitas señaladas en el protocolo en un estudio Adamas de eficacia
    anterior.
    3. Pacientes ambulatorios o que utilicen alguna ayuda para caminar (p. ej., andador o
    bastón) durante los periodos ON, de forma que puedan realizar las evaluaciones del
    estudio.
    4. Cuidador o pareja en el estudio de confianza y que conozca bien al sujeto, cuando
    proceda, que acompañe al sujeto a las visitas y le ayude a cumplimentar las evaluaciones
    del estudio cuando sea necesario y se lo permitan.
    5. Antecedentes de discinesia de pico de dosis que pueda mejorar con un tratamiento
    específico de la discinesia a criterio del sujeto y del investigador clínico.
    6. En tratamiento estable con medicación antiparkinsoniana, incluido un preparado de
    levodopa administrado no menos de tres veces al día.
    Grupo 2: sujetos incluidos anteriormente en un estudio Adamas sobre la DIL
    Seguidamente se describen los criterios de inclusión que deben cumplir los sujetos que
    participaron en un estudio Adamas de eficacia anterior en el que se evaluase ADS-5102 en la
    DIL y que vayan a incorporarse al ADS-AMT-PD302 tras un cierto intervalo:
    1. Firma del documento de consentimiento informado aprobado por el CEIC.
    2. Realización de las visitas señaladas en el protocolo en un estudio Adamas de eficacia
    anterior.
    3. Pacientes ambulatorios o que utilicen alguna ayuda para caminar (p. ej., andador o
    bastón) durante los periodos ON, de forma que puedan realizar las evaluaciones del
    estudio.
    4. Cuidador o pareja en el estudio de confianza y que conozca bien al sujeto, cuando
    proceda, que acompañe al sujeto a las visitas y le ayude a cumplimentar los instrumentos
    del estudio cuando sea necesario y se lo permitan.
    5. Discinesia de pico de dosis durante la selección que pueda mejorar con un tratamiento
    específico de la discinesia a criterio del sujeto y del investigador clínico O antecedentes
    de discinesia de pico de dosis que se esté tratando actualmente con amantadina.
    6. En tratamiento estable con medicación antiparkinsoniana durante al menos 30 días antes
    de la selección, incluido un preparado de levodopa administrado no menos de tres veces
    al día.
    7. Enfermedad de Parkinson, conforme a los criterios clínicos de diagnóstico del Banco de
    Cerebros de la UK Parkinson's Disease Society (UKPDS) (véase el Apéndice C)
    Grupo 3: sujetos no incluidos en un estudio Adamas sobre la DIL sometidos a
    ECP previa
    Seguidamente se describen los criterios de participación que se aplican a los sujetos que no se
    habrían considerado candidatos a participar en otros estudios Adamas de eficacia anteriores o
    actuales por haberse sometido a estimulación cerebral profunda:
    1. Firma del documento de consentimiento informado aprobado por el CEIC.
    2. Aplicación de un procedimiento de estimulación cerebral profunda antes del comienzo de
    este estudio (14 de julio de 2014).
    3. Pacientes ambulatorios o que utilicen alguna ayuda para caminar (p. ej., andador o
    bastón) durante los periodos ON, de forma que puedan realizar las evaluaciones del
    estudio.
    4. Cuidador o pareja en el estudio de confianza y que conozca bien al sujeto, cuando
    proceda, que acompañe al sujeto a las visitas y le ayude a cumplimentar los instrumentos
    del estudio cuando sea necesario y se lo permitan.
    5. Discinesia de pico de dosis durante la selección que pueda mejorar con un tratamiento
    específico de la discinesia a criterio del sujeto y del investigador clínico O antecedentes
    de discinesia de pico de dosis que se esté tratando actualmente con amantadina.
    6. En tratamiento estable con medicación antiparkinsoniana durante al menos 30 días antes
    de la selección, incluido un preparado de levodopa administrado no menos de tres veces
    al día.
    7. Enfermedad de Parkinson, conforme a los criterios clínicos de diagnóstico del Banco de
    Cerebros de la UK Parkinson's Disease Society (UKPDS) (véase el Apéndice C)
    E.4Principal exclusion criteria
    Group 1 Current Adamas subjects
    Discontinued due to ADS-5102-AEs
    H&Y Stage 5
    Presence of orthostatic hypotension
    GFR < 50 mL/min/1.73m2
    Female is pregnant or lactating
    Sexually active female, not sterile or 2 y postmenopausal, or will not use highly effective hormonal contraception, with a barrier, from screening to least 4 weeks post-treatment
    Possible treatment with restricted medication
    Planned participation in another trial
    Group 2 Previous Adamas subjects
    Discontinued due to ADS-5102-AEs
    History of neurosurgery related to PD, Except DBS
    History of other neurological disease that would affect motor function or cognition
    Current sensory impairments impairing assessment completion or untreated angle closure glaucoma
    History of alcohol or substance dependence or abuse seizures, stroke or TIA since completion in previous Adamas trial
    History of MI, or NYHA Functional Classification of Heart Failure Class 3 or 4 since completion of participation in previous Adamas trial
    Any clinically significant ECG other than isolated PVCs or first degree AV block
    History of cancer since completion in previous Adamas trial
    MMSE<24 during screening
    H&Y Stage 5
    Presence of an acute or chronic major psychiatric disorder or symptom (e.g. suicidal ideation) that would affect ability to complete assessments
    Presence of orthostatic hypotension
    Any of the following results at screening:
    ?Hb<10g/dL
    ?WBC<3.0x1e9/L
    ?Neutrophils<1.5x1e9/L
    ?Lymphocytes<0.5x1e9/L
    ?Platelets<100x1e9/L
    ?AST &/or ALT>2 ULN
    GFR<50mL/min/1.73m2
    Can?t swallow oral capsules or GI malabsorption
    Female is pregnant or lactating
    Sexually active female, not sterile or 2 y postmenopausal, or will not use highly effective hormonal contraception, with a barrier, from screening to least 4 weeks post-treatment
    Inability to tolerate amantadine or history of suicidal ideation or suicide attempt during prior amantadine use
    History of hypersensitivity or allergic reaction to amantadine, rimantidine, or memantine, or to any of the excipients used in the study medication
    Received live attenuated influenza vaccine within 2 weeks prior to enrolment
    Current treatment with carbonic anhydrase inhibitors, sodium bicarbonate, or urinary acidification agents, quinine, quinidine, triamterene, or trimethoprim
    Current treatment with medications that act primarily by blocking dopamine receptors & current treatment with medications that prolong the QT interval & known risk of torsades de pointes
    Treatment with an investigational drug (other than ADS-5102) within 30 days prior to screening
    Treatment with an investigational biologic 6 m to screening
    Possible treatment with restricted medication
    Current/planned participation in another trial
    Group 3 Non Adamas Subjects ? with prior DBS
    History of neurosurgery related to PD, except DBS
    History of other neurological disease that would affect motor function/cognition
    Current sensory impairments impairing assessment completion or untreated angle closure glaucoma
    History of alcohol or substance dependence or abuse, seizures, stroke or TIA within 2 y prior to screening
    History of MI, or NYHA Functional Classification of Heart Failure Class 3 or 4 within 2 y prior to screening
    Any clinically significant ECG abnormalities other than isolated PVCs or first degree AV block
    History of cancer within 5 y of screening
    MMSE score <24 in screening
    H&Y Stage 5
    Presence of an acute or chronic major psychiatric disorder or symptom (e.g. suicidal ideation) that would affect ability to complete assessments
    Presence of orthostatic hypotension
    Any of the following results at screening:
    ?Hb<10g/dL
    ?WBC<3.0x1e9/L
    ?Neutrophils<1.5x1e9/L
    ?Lymphocytes<0.5x1e9/L
    ?Platelets<100x1e9/L
    ?AST&/orALT>2 ULN
    GFR < 50 mL/min/1.73m2
    Can?t swallow oral capsules or GI malabsorption
    Female is pregnant or lactating
    Sexually active female, not sterile or 2 y postmenopausal, or will not use highly effective hormonal contraception, with a barrier, from screening to least 4 weeks post-treatment
    Inability to tolerate amantadine or history of suicidal ideation or suicide attempt during prior amantadine use
    History of hypersensitivity or allergic reaction to amantadine, rimantidine, or memantine, or to any of the excipients used in the medication
    Received live attenuated influenza vaccine within 2 weeks prior to enrolment
    Current treatment with carbonic anhydrase inhibitors, sodium bicarbonate, or urinary acidification agents, quinine, quinidine, triamterene, or trimethoprim
    Current treatment with medications that act primarily by blocking dopamine receptors & current treatment with medications that prolong the QT interval & known risk of torsades de pointes
    Treatment with an investigational drug (other than ADS-5102) within 30d prior to screening
    Treatment with an investigational biologic 6 m prior to screening
    Possible treatment with restricted medication
    Current/planned participation in another trial
    Grupo 1 sujetos incluidos actualmente en un estudio Adamas sobre la DIL Seguidamente se describen los criterios de exclusión que se aplican a los sujetos que se incorporen directamente al estudio ADS-AMT-PD302 sin dejar un intervalo entre el estudio Adamas de eficacia en la DIL y el ADS-AMT-PD302
    Grupo 2 sujetos incluidos anteriormente en un estudio Adamas sobre la DIL Seguidamente se describen los criterios de exclusión que se aplican a los sujetos que participaron en un estudio Adamas de eficacia anterior en el que se evaluase ADS-5102 en la DIL y que vayan a incorporarse al ADS-AMT-PD302 tras un cierto intervalo
    Grupo 3 sujetos no incluidos en un estudio Adamas sobre la DIL sometidos a
    ECP previa Seguidamente se describen los criterios de participación que se aplican a los sujetos que no se habrían considerado candidatos a participar en otros estudios Adamas de eficacia anteriores o actuales por haberse sometido a estimulación cerebral profunda
    2 Estadio 5 en la Escala de Hoehn and Yahr
    3 Presencia de hipotensión ortostática en la selección: disminución de la presión arterial sistólica (de al menos 20 mm Hg) o diastólica (de al menos 10 mm Hg) en una determinación realizada menos de 3 minutos después de que el sujeto se ponga de pie, en comparación con los valores obtenidos en sedestación
    4 FG estimada < 50 ml/min/1,73 m2 (calculada con la fórmula de MDRD)
    5 Mujeres embarazadas o lactantes
    6 En el caso de las mujeres sexualmente activas, la paciente no ha sido esterilizada quirúrgicamente o no lleva como mínimo 2 años de posmenopausia, o no está dispuesta a utilizar un método anticonceptivo hormonal altamente eficaz (dispositivo intrauterino (DIU) o vasectomía de la pareja también son aceptables) combinado con un método de barrera desde la selección hasta al menos 4 semanas después del final del tratamiento del studio
    2 Antecedentes de intervención neuroquirúrgica relacionada con la enfermedad de
    Parkinson, a excepción de estimulación cerebral profunda
    3 Antecedentes de otra enfermedad neurológica que, en opinión del investigador, pueda afectar a la función motora o a la función cognitiva, entre otras, demencia de tipo Alzheimer, enfermedad de Huntington, demencia con cuerpos de Lewy, demencia frontotemporal, degeneración corticobasal, parálisis supranuclear progresiva, atrofia multisistémica, disfunción motora o sensitiva secundaria a un ictus o a un traumatismo
    cerebral o demencia multiinfarto con lagunas
    4 Presencia de deterioro sensorial (p. ej., auditivo, visual) que, en opinión del investigador, pueda mermar la capacidad del sujeto para realizar las evaluaciones del studio de la participación en el ensayo Adamas anterior, o presencia de glaucoma de ángulo cerrado no tratado
    6 Antecedentes de crisis comiciales desde la conclusión de la participación en el ensayo Adamas anterior
    8 Antecedentes de infarto de miocardio o de insuficiencia cardíaca de clase 3 o 4 según la clasificación funcional de la NYHA desde la conclusión de la participación en el ensayo Adamas anterior
    9 Cualquier anomalía clínicamente significativa en el ECG, por ejemplo, signos de anomalías de la conducción o el ritmo ventriculares, aparte de extrasístoles ventriculares aisladas o bloqueo AV de primer grado
    10 Antecedentes de cáncer desde la conclusión de la participación en el ensayo Adamas anterior, con las excepciones siguientes: cáncer de piel no melanomatoso correctamente tratado, cáncer de vejiga localizado, cáncer de próstata no metastásico o cáncer de cuello uterino in situ
    11 Presencia de deterioro cognitivo, demostrado por una puntuación inferior a 24 en el Miniexamen el estado mental (MMSE) durante la selección.
    13. Presencia de un trastorno (p. ej., trastorno depresivo mayor) o síntoma (p. ej., alucinaciones, agitación, paranoia, ideación suicida) psiquiátrico mayor, agudo o crónico, que, en opinión del investigador, pueda influir en la capacidad del sujeto para realizar las evaluaciones del estudio
    15 Alguno de los resultados siguientes en las pruebas analíticas realizadas durante la selección:
    ??Hemoglobina < 10 g/dl
    ??Leucocitos < 3,0 x 109/l
    ??Neutrófilos < 1,5 x 109/l
    ??Linfocitos < 0,5 x 109/l
    ??Plaquetas < 100 x 109/l
    ??ALT o AST > 2 veces el
    límite superior de la normalidad.
    20 Intolerancia documentada a la amantadina , o antecedentes de ideación suicida o intento de suicidio durante el uso previo de amantadine
    23 Tratamiento actual con inhibidores de la anhidrasa carbónica, bicarbonato sódico, acidificantes
    de la orina, quinina, quinidina, triamtereno o trimetoprima
    24. Tratamiento actual con medicamentos cuyo principal mecanismo de acción sea el bloqueo de los receptores dopaminérgicos además de tratamiento actual con medicamentos que prolonguen el intervalo QT y tengan riesgo conocido de provocar Torsades de Pointes (véase el Apéndice E). Los sujetos que puedan dejar de tomar estos medicamentos sin riesgo como mínimo 60 días antes de la selección serán aptos para la selección
    E.5 End points
    E.5.1Primary end point(s)
    The following safety assessments will be performed during the study:
    ? AEs
    ? Safety-related study drug discontinuations
    ? Vital signs
    ? Safety laboratory tests
    Se efectuarán las siguientes evaluaciones de la seguridad durante el estudio:
    ? AA
    ? Suspensiones de la medicación del estudio por motivos de seguridad
    ? Constantes vitales
    ? Pruebas analíticas de seguridad
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary outcome measure is the change from baseline to Week 52
    El criterio de valoración principal es la variación desde la visita basal hasta la semana 52
    E.5.2Secondary end point(s)
    The following efficacy assessment will be performed during the study:
    ? Unified Parkinson?s Disease Rating Scale (MDS-UPDRS)
    Se efectuará la siguiente evaluación de la eficacia durante el estudio:
    ? Escala unificada para la evaluación de la enfermedad de Parkinson (Unified
    Parkinson?s Disease Rating Scale, MDS-UPDRS).
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary outcome measures are changes from baseline to Week 52
    El criterio de valoración siguente es la variación desde la visita basal hasta la semana 52
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial0
    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 EEA25
    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
    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
    LVLS
    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 months3
    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 months3
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 54
    F.4.2.2In the whole clinical trial 200
    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)
    Return patients to standard of care
    Volver a los pacientes al estándar de cuidado.
    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 Decision2015-03-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-11
    P. End of Trial
    P.End of Trial StatusCompleted
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