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    Summary
    EudraCT Number:2015-004912-39
    Sponsor's Protocol Code Number:B7601003
    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:2016-05-17
    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 number2015-004912-39
    A.3Full title of the trial
    A 15-WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE RANGING STUDY TO INVESTIGATE THE
    EFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON'S DISEASE
    ESTUDIO EN FASE II DE BÚSQUEDA DE DOSIS, DOBLE CIEGO, ALEATORIZADO, CONTROLADO CON PLACEBO Y DE 15 SEMANAS DE DURACIÓN PARA INVESTIGAR LA EFICACIA, LA SEGURIDAD Y LA TOLERABILIDAD DEL PF-06649751 EN SUJETOS CON FLUCTUACIONES MOTORAS POR ENFERMEDAD DE PARKINSON
    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 MOTOR FLUCTUATIONS DUE TO PARKINSON'S DISEASE
    UN ESTUDIO CLÍNICO DE 15 SEMANAS PARA DETERMINAR LA EFECTIVIDAD, SEGURIDAD Y TOLERABILIDAD DE PF-06649751 EN PACIENTES CON FLUCTUACIONES MOTORAS POR ENFERMEDAD DE PARKINSON
    A.4.1Sponsor's protocol code numberB7601003
    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 pointAndreas Meier
    B.5.3 Address:
    B.5.3.1Street Address610 Main Street, 5th Floor
    B.5.3.2Town/ cityCambridge, MA
    B.5.3.3Post code02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number+3491 490 99 00
    B.5.6E-mailclinicaltrials.govcallcenter@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 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: 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 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
    D.8 Placebo: 2
    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 Parkinson
    E.1.1.1Medical condition in easily understood language
    Gradually developing disorder of the nervous system that affects movement.
    Patología de desarrollo gradual 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 19.0
    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 on motor symptoms of PF-06649751 administered once daily as adjunctive treatment with stable doses of L-Dopa in Parkinson's disease.
    - To determine the therapeutic window for motor symptom improvement of PF-06649751 administered once daily, ie, determining a dose, or a range of doses, for adequate control of motor symptoms.
    - Evaluar el efecto sobre los síntomas motores del PF-06649751 administrado una vez al día como tratamiento complementario con dosis estables de L-Dopa en enfermedad de Parkinson.
    - Determinar el margen terapéutico para la mejora de los síntomas motores del PF-06649751 administrado una vez al día, es decir, determinar una dosis o un rango de dosis, para el control adecuado de los síntomas motores.
    E.2.2Secondary objectives of the trial
    - To evaluate the dose-response on motor symptoms of PF-06649751 administered once daily in subjects with Parkinson's disease.
    - To evaluate the reduction of L-Dopa dose while used concomitantly with once daily PF-06649751.
    - To evaluate the safety and tolerability of PF-06649751 administered once daily in subjects with Parkinson's disease.
    - To evaluate the effect of PF-06649751 administered once daily on dyskinesia in subjects with Parkinson's disease.
    - Evaluar la dosis y el efecto sobre los síntomas motores del PF-06649751 administrado una vez al día en pacientes con enfermedad de Parkinson.
    - Evaluar la reducción de la dosis de L-Dopa durante su uso concomitante con el PF-06649751 una vez al día.
    - Evaluar la seguridad y la tolerabilidad del PF-06649751 administrado una vez al día en sujetos con enfermedad de Parkinson.
    - Evaluar el efecto del PF-06649751 administrado una vez al día sobre la discinesia en sujetos con enfermedad de Parkinson.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Clinical diagnosis of Parkinson's disease consistent with the United Kingdom (UK) Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria.
    - Parkinson's disease Hoehn & Yahr Stage less than or equal to III while the subject is ON.
    - Currently responding to L-Dopa therapy.
    - Total duration of 2.5 hours OFF time each day, based on the OFF time diary (Hauser diary) collected over 3 consecutive days during the screening period (with fewer than 4 errors or missing entries in diary data per day) and at least 75% concordance with investigator for Screening ON/OFF time concordance testing (see Concordance Testing and OFF Time Diary Training).
    - Subjects must be able to recognize their 'wearing off' symptoms and confirm that they usually improve after their next dose of Parkinson's disease medication.
    - On a stable dose of L-Dopa of at least 400 mg total daily dose for at least 28 days prior to Day 0 (Randomization), in conjunction with a dopa-decarboxylase inhibitor (eg, L-Dopa/carbidopa or L-Dopa/benserazide) divided in at least 4 doses per day.
    - Willing and able to refrain from any Parkinson's disease medication not permitted by the protocol throughout participation in the study.
    - Body Mass Index (BMI) of 17.5 to 35 kg/m2; and a total body weight 45 kg.
    - A score of 26 on the Mini Mental State Examination (MMSE).
    - Diagnóstico clínico de enfermedad de Parkinson coherente con los Criterios de diagnóstico clínico del Banco de Cerebros de la Sociedad de Enfermedad de Parkinson del Reino Unido.
    - Enfermedad de Parkinson en estadio inferior o igual a III de Hoehn & Yahr mientras el paciente está en fase ON.
    - Actualmente responde al tratamiento con L-Dopa.
    - Duración total de >= 2,5 horas de tiempo en fase OFF cada día, basándose en el diario de tiempo en fase OFF (diario de Hauser) registrado durante 3 días consecutivos durante el periodo de selección (con menos de 4 errores o entradas ausentes en los datos del diario al día) y al menos un 75 % de concordancia con el investigador para la prueba de concordancia del tiempo en fase ON/OFF de la selección (véase Prueba de concordancia y formación sobre el diario del tiempo en fase OFF).
    - Los sujetos deben ser capaces de reconocer sus síntomas de «esfumación de la respuesta» (wearing off) y confirmar que normalmente mejoran tras su siguiente dosis de medicación para la enfermedad de Parkinson.
    - Los sujetos deben estar tomando una dosis estable de L-Dopa de al menos 400 mg totales al día durante al menos 28 días antes del día 0 (aleatorización), junto con un inhibidor de la dopa-descarboxilasa (p. ej., L-Dopa/carbidopa o L-Dopa/benserazida) dividido en al menos 4 dosis al día.
    - Los sujetos deben estar dispuestos y ser capaces de abstenerse de tomar cualquier medicamento para la enfermedad de Parkinson que no esté permitido por el protocolo durante su participación en el estudio.
    - Índice de masa corporal (IMC) de 17,5 a 35 kg/m2; y un peso corporal total de >= 45 kg.
    - Una puntuación de >= 26 en el miniexamen del estado mental (MMSE).
    E.4Principal exclusion criteria
    - History or clinical features consistent with an atypical Parkinsonian syndrome.
    - History of surgical intervention for Parkinson's disease (pallidotomy, thalamotomy, deep brain stimulation, etc).
    - A score of 4 on item 4.2 Functional Impact of Dyskinesias of MDS-UPDRS Part IV (motor complications) at Screening.
    - Psychotic symptoms related to Parkinson's disease requiring treatment with an antipsychotic medication within 6 months prior to Screening.
    - Any Parkinson's disease-related feature or symptom that could interfere with the study conduct and results as assessed by the sponsor or Investigator.
    - Severe acute or chronic medical or psychiatric condition 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.
    - Presence or history of brain tumor, past history of hospitalization for head trauma with loss of consciousness, epilepsy, including childhood seizures, or conditions that lower seizure threshold, seizures of any etiology (including substance or drug
    withdrawal), or known increased risk of seizures.
    - A 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) that in the opinion of the investigator could interfere with study participation or poses a risk to the subject. Presence of minor depression or treated, stable depressive disorder is acceptable.
    - History of clinically significant alcohol or substance dependency (other than caffeine or nicotine), as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), within 1 year before Screening.
    - 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.
    - Any condition possibly affecting drug absorption, past surgery of the gastrointestinal tract (eg, gastrectomy, colectomy), except cholecystectomy.
    - History of Human immunodeficiency virus (HIV) infection.
    - 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).
    - Subjects with first degree family history of unexplained sudden death, or of Long QT syndrome (LQTS).
    - Currently receiving an antipsychotic, metoclopramide, reserpine, or amphetamine.
    - Currently receiving moderate or strong CYP3A4 inducers or CYP3A4 inhibitors (except for topical administration).
    - Previous implantation of apomorphine pump, or surgery for intraduodenal use of Duodopa.
    - Antecedentes o características clínicas coherentes con un síndrome parkinsoniano atípico.
    - Antecedentes de intervención quirúrgica para la enfermedad de Parkinson (palidotomía, talatomía, estimulación cerebral profunda, etc.).
    - Una puntuación de 4 en el ítem 4.2 Impacto funcional de discinesias de la parte IV del MDS-UPDRS (complicaciones motoras) en la selección.
    - Síntomas psicóticos relacionados con la enfermedad de Parkinson que requieran un tratamiento con fármacos antipsicóticos en los 6 meses previos a la selección.
    - Cualquier característica o síntoma relacionado con la enfermedad de Parkinson que pudiera interferir con la realización del estudio y los resultados, según la valoración del promotor o el investigador.
    - Afección médica o psiquiátrica o anomalía analítica crónica o aguda grave que pueda aumentar el riesgo asociado con la participación en el estudio o la administración del producto en investigación o que pueda interferir en la interpretación de los resultados del estudio y que, a juicio del investigador, haría que el sujeto no fuera apto para participar en este estudio.
    - Presencia o antecedentes de tumor cerebral, antecedentes de hospitalización por traumatismo craneoencefálico con pérdida de conciencia, epilepsia, incluidas crisis infantiles, o afecciones que reducen el umbral de crisis epilépticas, convulsiones de cualquier etiología (incluidas las convulsiones por abstinencia de drogas o fármacos) o un riesgo elevado conocido de crisis epilépticas.
    - Una enfermedad psiquiátrica importante del Eje I según la definición del Manual Diagnóstico y Estadístico de los Trastornos Mentales, 4.ª edición, Texto Revisado (DSM IV-TR, American Psychiatric Association, 2000) que, en opinión del investigador pudiera interferir con la participación del estudio o suponer un riesgo para el sujeto. Es aceptable la presencia de depresión menor o trastorno depresivo estable tratado.
    - Antecedentes de dependencia clínicamente significativa de alcohol o sustancias (aparte de cafeína o nicotina), tal como se define en el Manual Diagnóstico y Estadístico de los Trastornos Mentales, 4.ª edición (DSM-IV), en el plazo de 1 año antes de la selección.
    - En opinión del investigador (o cuidador, según proceda), presenta signos o síntomas que sugieren una afectación cognitiva clínicamente significativa que interferiría con la capacidad de cumplir con los procedimientos del estudio.
    - Cualquier afección que pudiera afectar la absorción del fármaco, cirugía previa del tubo digestivo (p. ej., gastrectomía, colectomía), salvo colecistectomía.
    - Antecedentes de infección por el virus de la inmunodeficiencia humana (VIH).
    - Antecedentes de neoplasia maligna (aparte de carcinoma basal no metastásico o carcinoma de células escamosas de la piel o carcinoma localizado que haya sido extirpado quirúrgicamente en total >1 año antes de la selección y que no haya reaparecido).
    - Sujetos con antecedentes familiares de primer grado de muerte súbita inexplicada o síndrome del QT prolongado (SQTP).
    - Sujetos que actualmente estén tomando un antipsicótico, metoclopramida, reserpina o anfetamina.
    - Sujetos que actualmente estén tomando inductores moderados o potentes de CYP3A4 o inhibidores de CYP3A4 (salvo para la administración tópica).
    - Implantación previa de una bomba de apomorfina o cirugía para el uso intraduodenal de Duodopa.
    E.5 End points
    E.5.1Primary end point(s)
    (Efficacy) Change from baseline in daily OFF time (based on patient reported Hauser diary) at Week 10 (end of Period A).
    (Eficacia) Variación respecto al inicio del estudio en el tiempo diario en fase OFF (basándose en el diario de Hauser informado por el paciente) en la semana 10 (final del periodo A).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 10
    Semana 10
    E.5.2Secondary end point(s)
    (Efficacy; Evaluated during the entire double-blind period)
    Placebo corrected change from baseline in:
    - Daily OFF time.
    - Daily ON time without troublesome dyskinesia.
    - MDS - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III.
    - MDS-UPDRS Parts I, II, IV, and total score.
    (Endpoints evaluated at the ends of Period A and B)
    - % reduction in total daily L-Dopa dose from pre-study baseline at Weeks 10 and 15.
    - Number of subjects with 25, 50%, 75% and with 100% reduction from pre-study
    baseline in daily L-Dopa dose at Weeks 10 and 15.
    Safety and Tolerability
    - Adverse events.
    - Clinical laboratory parameters.
    - Vital signs.
    - 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).
    (Eficacia; evaluada durante todo el periodo a doble ciego)
    Variación corregida con placebo respecto al inicio del estudio en:
    - Tiempo diario en fase OFF.
    - Tiempo diario en fase ON sin discinesia problemática.
    - Parte III de la Escala Unificada de Evaluación de la Enfermedad de Parkinson de la MDS (MDS-UPDRS).
    - Partes I, II, IV y puntuación total de la MDS-UPDRS.
    (Criterios de valoración evaluados al final del periodo A y periodo B)
    - Reducción porcentual de la dosis total diaria de L-Dopa respecto al valor basal previo al estudio en las semanas 10 y 15.
    - Número de sujetos con reducciones del >= 25 %, >= 50 %, >= 75 % y 100 % respecto a los valores basales previos al estudio en la dosis de L-Dopa diaria en las semanas 10 y 15.
    Seguridad y tolerabilidad
    - Acontecimientos adversos.
    - Parámetros analíticos.
    - Constantes vitales.
    - Parámetros ECG.
    - Escala Columbia para evaluar la seriedad de la ideación suicida (C-SSRS).
    - Cuestionario sobre trastornos impulsivos y compulsivos en la enfermedad de Parkinson - escala de valoración (QUIP-RS).
    - Lista de verificación de la abstinencia por el médico (PWC-20)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy - Evaluated during the entire double-blind period
    Other endpoints - evaluated at the ends of Period A and B
    Eficacia - evaluada durante todo el periodo a doble ciego.
    Otros criterios de valoración secundarios - evaluados al final del periodo A y periodo B.
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    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 trial5
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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
    Japan
    Spain
    United Kingdom
    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
    LVLS
    UVUP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days15
    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: 99
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 99
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 66
    F.4.2.2In the whole clinical trial 198
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-11-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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