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    Summary
    EudraCT Number:2017-000877-35
    Sponsor's Protocol Code Number:BB-2001-201b
    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:2017-06-09
    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 number2017-000877-35
    A.3Full title of the trial
    Dose finding phase IIb study of Bavisant to evaluate its safety and efficacy in treatment of excessive daytime sleepiness (EDS) in parkinson’s Disease (PD).
    Estudio fase IIb de búsqueda de dosis para evaluar la seguridad y eficacia de Bavisant en el tratamiento de la somnolencia diurna excesiva (SDE) en pacientes con enfermedad de Parkinson (EP).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase IIb, randomized, double blind, parallel group, placebo control, multicentre, 6-week dose-finding study to assess the efficacy and safety of Bavisant for the treatment of excessive daytime sleepiness in subjects with Parkinson's disease.
    Un estudio de búsqueda de dosis de fase IIb, aleatorizado, doble ciego, de grupos paralelos, con control de placebo, multicéntrico, de 6 semanas para evaluar la eficacia y seguridad de Bavisant para el tratamiento de la somnolencia diurna excesiva en sujetos con enfermedad de Parkinson.
    A.3.2Name or abbreviated title of the trial where available
    Treatment of excessive daytime sleepiness with Bavisant in Parkinson’s Disease Patients (CASPAR)
    Tratamiento de la somnolencia diurna excesiva con Bavisant en pacientes con enfermedad de Parkinson
    A.4.1Sponsor's protocol code numberBB-2001-201b
    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 SponsorBenevolentAI Bio
    B.1.3.4CountryUnited Kingdom
    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 supportBenevolentAI Bio
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBenevolentAI Bio
    B.5.2Functional name of contact pointAdepeju Oshisanya
    B.5.3 Address:
    B.5.3.1Street Address40 Churchway
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW1 1LW
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44203096 0737
    B.5.6E-mailadepeju.oshisanya@benevolent.ai
    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 nameBavisant
    D.3.2Product code JNJ-31001074
    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 INNBavisant dihydrochloride monohydrate
    D.3.9.3Other descriptive nameBAVISANT HYDROCHLORIDE MONOHYDRATE
    D.3.9.4EV Substance CodeSUB30870
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation 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 nameBavisant
    D.3.2Product code JNJ-31001074
    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 INNBavisant dihydrochloride monohydrate
    D.3.9.3Other descriptive nameBAVISANT HYDROCHLORIDE MONOHYDRATE
    D.3.9.4EV Substance CodeSUB30870
    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 nameBavisant
    D.3.2Product code JNJ-31001074
    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 INNBavisant dihydrochloride monohydrate
    D.3.9.3Other descriptive nameBAVISANT HYDROCHLORIDE MONOHYDRATE
    D.3.9.4EV Substance CodeSUB30870
    D.3.10 Strength
    D.3.10.1Concentration unit millilitre(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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
    Excessive daytime sleepiness with Parkinson's Disease
    Somnolencia diurna excesiva con la enfermedad de Parkinson
    E.1.1.1Medical condition in easily understood language
    Parkinson's Disease
    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 20.0
    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 assess the efficacy of Bavisant compared to placebo after a 6-week treatment period on the excessive daytime sleepiness in Parkinson's disease.
    Evaluar la eficacia de Bavisant respecto a placebo después de un periodo de tratamiento de 6 semanas sobre la somnolencia diurna excesiva en la enfermedad de Parkinson.
    E.2.2Secondary objectives of the trial
    To assess the efficacy and safety assessment of Bavisant compared to placebo after 2 weeks and 6 weeks of treatment. The efficacy assessment will include excessive daytime sleepiness, motor control, and depression.
    Evaluar la eficacia y la seguridad de Bavisant respecto a placebo después de 2 semanas y 6 semanas de tratamiento. La evaluación de la eficacia incluirá la somnolencia diurna excesiva, el control motor y la depresión.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1) Signed informed consent (no study-related procedures may be performed before the subject has signed the consent form).
    (2) Subjects of either sex aged 50 to 80 years (both inclusive and relative to Day 1).
    (3) Subjects with previous diagnosis of Parkinson's disease (following the UK Parkinson’s disease society brain bank clinical diagnostic criteria).
    (4) Subjects capable of understanding and complying with protocol requirements.
    (5) Subjects with medical history of excessive daytime sleepiness.
    (6) Subjects with moderate or severe excessive daytime sleepiness indicated by an Epworth Sleepiness Score (ESS) > 12 at screening .
    (7) Subjects with stable nocturnal sleep hygiene practices (e.g. temperature, darkness, quiet, place to lie down and stretch out) as per investigator's judgement.
    (8) Male subjects who are nonsterilized and sexually active with a female partner of childbearing potential agree to use adequate contraception from signing of informed consent throughout the duration of the study and for 4 weeks after last dose.
    (9) Female subjects of childbearing potential who are sexually active with a nonsterilized male partner agree to use adequate contraception from signing of informed consent throughout the duration of the study and for 4 weeks after last dose.
    (10) Subjects on stable permitted concomitant medication for at least 4 weeks before screening.
    (1) Firma del consentimiento informado (no pueden realizarse procedimientos relacionados con el estudio antes de que el sujeto firme el consentimiento).
    (2) Sujetos de ambos sexos de 50 a 80 años (incluidas ambas edades y respecto al día 1).
    (3) Sujetos con diagnóstico previo de enfermedad de Parkinson (según los criterios de diagnóstico clínico del Banco de Cerebros de la Sociedad de la Enfermedad de Parkinson del Reino Unido).
    (4) Sujetos capaces de comprender y cumplir con los requisitos del protocolo.
    (5) Sujetos con antecedentes médicos de somnolencia diurna excesiva.
    (6) Sujetos con somnolencia diurna excesiva moderada o grave indicada por una puntuación según la escala de somnolencia de Epworth (ESS) > 12 en la selección.
    (7) Sujetos con hábitos de higiene de sueño nocturno estables (p. ej. temperatura, oscuridad, silencio, un sitio para tumbarse y estirarse) según el criterio del investigador.
    (8) Los sujetos varones no esterilizados y sexualmente activos con una pareja mujer en edad fértil deben aceptar el uso de un método anticonceptivo adecuado a partir de la firma del consentimiento informado durante todo el estudio y las 4 semanas siguientes a la última dosis.
    (9) Las mujeres en edad fértil sexualmente activas con una pareja del otro sexo no esterilizada deben aceptar el uso de un método anticonceptivo adecuado a partir de la firma del consentimiento informado durante todo el estudio y las 4 semanas siguientes a la última dosis.
    (10) Sujetos en tratamiento con medicación concomitante permitida a dosis estable al menos durante 4 semanas antes de la selección.
    E.4Principal exclusion criteria
    (1) Subjects with excessive daytime sleepiness due to conditions other than Parkinson's disease (including narcolepsy)
    (2) Subjects with significant eye disease which may substantially impact the subject's mobility and ability to have eye examination conducted as per investigator's judgement.
    (3) Subjects with clinical evidence of depression with significant psychiatric comorbidities (Hamilton Rating Scale for Depression - HAM-D score ≥ 17; with or without treatment)
    (4) Subjects with evidence of significant Cognitive Impairment (Montreal Cognitive Assessment - MoCA score ≤ 22 at screening)
    (5) Subjects with evidence of significant fatigue (Fatigue Severity Scale - FSS ≥ 36)
    (6) Subjects with high risk of sleep apnoea (Berlin questionnaire with ≥ 2 categories where the score is positive)
    (7) Subjects taking any of the following prohibited medications at screening:
     Alerting agents, including r-modafinil, modafinil or methylphenidate
     Benzodiazepines
     Histamine active agents
     Hypnotics
     Cholinergics
     Skeletal muscle relaxants
     Clozapine
     Atomoxetine
     Amitriptyline
     Any other daytime medications which affect sleep
    (8) Subjects with chronic oral and / or ophthalmic steroidal use
    (9) Subjects with either renal or hepatic impairment defined by laboratory parameters >1.5x age-adjusted limits of normal range
     Hepatic damage: Alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase, or total bilirubin
     Renal damage: Blood creatinine, blood urea nitrogen [BUN], or estimated glomerular filtration rate [eGFR] < 60 mL/min/1.73m2
    (10) Subjects with abnormal ECG time intervals at baseline including QTc (> 450 for males and > 470 for females)
    (11) Subjects with known history of lung malignancy.
    (12) Subjects with known history of abuse of alcohol or other addictive substances in the 6 months prior to inclusion.
    (13) Subjects with known allergies or hypersensitivity to Bavisant or any of its excipients.
    (14) Subjects who are pregnant or lactating.
    (15) Subjects who do not wish to or cannot comply with study procedures.
    (16) Subjects currently receiving, or having received within 3 months prior to enrolment into this clinical study, any investigational drug.
    (17) Subjects who are study-site employees, or are immediate family members (i.e., spouse, parent, child, sibling) of a study site employee involved in conduct of this study.
    (1) Sujetos con somnolencia diurna excesiva debida a enfermedades que no sean la enfermedad de Parkinson (incluida la narcolepsia)
    (2) Sujetos con una patología ocular significativa que podría afectar sustancialmente a su movilidad y la capacidad de someterse a una exploración oftalmológica, según el criterio del investigador.
    (3) Sujetos con indicios clínicos de depresión con comorbilidades psiquiátricas significativas (puntuación según la Escala para la evaluación de la depresión de Hamilton - HAM-D ≥ 17; con o sin tratamiento)
    (4) Sujetos con indicios de deterioro cognitivo significativo (puntuación de la Evaluación cognitiva de Montreal - ECMo ≤ 22 en la selección)
    (5) Sujetos con indicios de fatiga significativa (Escala de gravedad de la fatiga - FSS ≥ 36)
    (6) Sujetos con riesgo alto de apnea del sueño (cuestionario Berlín con ≥ 2 categorías con una puntuación positiva)
    (7) Sujetos que estén tomando cualquiera de los siguientes medicamentos prohibidos en el momento de la selección:
    • Fármacos activadores de la vigilia, incluyendo R-modafinilo, modafinilo o metilfenidato
    • Benzodiacepinas
    • Antihistamínicos activos
    • Hipnóticos
    • Colinérgicos
    • Relajantes esquelético musculares
    • Clozapina
    • Atomoxetina
    • Amitriptilina
    • Cualquier otra medicación diurna que pueda afectar al sueño
    (8) Sujetos con uso crónico de esteroides por vía oral y/u oftálmica
    (9) Sujetos con insuficiencia renal o hepática definida por parámetros analíticos >1,5 x límite del rango normal ajustado por edad
    • Daño hepático: Alanina aminotransferasa [ALT], aspartato aminotransferasa [AST], fosfatasa alcalina o bilirrubina total
    • Daño renal: Creatinina en sangre, urea [BUN] o filtración glomerular estimada [FGe] < 60 ml/min/1,73 m2
    (10) Sujetos con intervalos anómalos en el ECG en situación inicial incluyendo QTc (> 450 para varones y > 470 para mujeres)
    (11) Sujetos con antecedentes comprobados de cáncer de pulmón maligno.
    (12) Sujetos con antecedentes comprobados de abuso de alcohol u otras sustancias adictivas en los 6 meses anteriores a la inclusión.
    (13) Sujetos con alergias o hipersensibilidad comprobadas a Bavisant o cualquiera de sus excipientes.
    (14) Mujeres embarazadas o en periodo de lactancia
    (15) Sujetos que no deseen o no puedan cumplir con los procedimientos del estudio.
    (16) Sujetos que estén recibiendo o hayan recibido algún fármaco en investigación en los 3 meses anteriores a la inclusión en este estudio clínico.
    (17) Sujetos que sean empleados del centro del estudio o que sean familiares directos (es decir, cónyuge, progenitor, hijo/a, hermano/a) de un empleado del centro del estudio implicado en su realización.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the mean absolute change of treatment groups in the Epworth Sleepiness Scale (ESS) from baseline to the end of the 6-week treatment period, assessed as both the intragroup change compared to baseline and intergroup change compared to placebo.
    La variable principal será el cambio en la media absoluta de la Escala de Somnolencia de Epworth (ESS) en los grupos de tratamiento entre la situación inicial y el final del periodo de tratamiento de 6 semanas, valorando tanto el cambio intragrupal comparado con la situación inicial y cambio intergrupal comparado con placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to the end of the 6-week treatment period.
    Desde el inicio hasta el final del período de tratamiento de 6 semanas.
    E.5.2Secondary end point(s)
    Efficacy in Excessive Daytime Sleepiness (EDS):
    • Mean absolute change in the Epworth Sleepiness Scale (ESS) from baseline to the end of the 2-week treatment period.
    • ESS clinical response, defined as ESS absolute decrease from baseline of at least 3.0 points, after 2 and 6 weeks of treatment.
    • ESS clinical response, defined as ESS ≤ 10 after 2 and 6 weeks of treatment.
    • ESS clinical response, defined as either ESS ≤ 10 after 2 and 6 weeks of treatment or ESS absolute decrease from baseline of at least 3.0 points after 2 and 6 weeks of treatment.
    • Mean relative change in the Epworth Sleepiness Scale (ESS) from baseline to the end of the 2-week and 6-week treatment periods (percentage of absolute decrease compared to baseline ESS).
    • Mean absolute change in the Scales for Outcome in Parkinson’s Disease Sleep (SCOPA- Sleep) from baseline to the end of the 2-week and 6-week treatment period.
    • Mean absolute change in the Parkinson's Disease Sleep Scale (PDSS-2) from baseline to the end of the 2-week and 6-week treatment period.
    • Mean absolute change in the Maintenance of Wakefulness Test (MWT) from baseline to the end of the 6-week treatment period.
    • Mean absolute change in the polysomnography from baseline to the end of the 6-week treatment period.
    Efficacy in Parkinson's disease (PD):
    • Mean absolute change in the MDS-UDPRS scale Part III (motor control) from baseline to the end of the 2-week and 6-week treatment period.
    • Mean absolute change in the depression BDI-II score from screening/baseline to the end of the 6-week treatment period.
    The safety of Bavisant compared to placebo will be assessed by the evaluation of the following:
    • Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs) as headache, nausea and insomnia
    • Incidence of physical examination, vital signs and laboratory tests findings (haematology and biochemistry)
    • Incidence of cardiovascular safety findings (blood pressure, heart rate, ECG including QT/QTc)
    • Incidence of slit lamp examination findings
    Eficacia en la somnolencia diurna excesiva (SDE):
    • Cambio en la media absoluta en la Escala de Somnolencia de Epworth (ESS) entre la situación inicial y el final del período de tratamiento de 2 semanas.
    • La respuesta clínica en la escala ESS, definida como una reducción absoluta en la ESS respecto al periodo inicial de al menos 3,0 puntos, después de 2 y 6 semanas de tratamiento.
    • La respuesta clínica en la escala ESS, definida como ESS ≤ 10 después de 2 y 6 semanas de tratamiento.
    • Respuesta clínica en la escala ESS, definida como ESS ≤ 10 después de 2 y 6 semanas de tratamiento o disminución absoluta de la escala ESS desde la situación inicial de al menos 3,0 puntos después de 2 y 6 semanas de tratamiento.
    • Cambio en la media relativa en la Escala de Somnolencia de Epworth (ESS) entre la situación inicial hasta el final de los períodos de tratamiento de 2 semanas y 6 semanas (porcentaje de disminución absoluta en comparación con la ESS basal).
    • Cambio en la media absoluta en las Escalas de Resultado en el Sueño de la Enfermedad de Parkinson (SCOPA- Sleep) desde el inicio hasta el final del período de tratamiento de 2 semanas y 6 semanas.
    • Cambio en la media absoluta en la escala de sueño de la enfermedad de Parkinson (PDSS-2) entre la situación inicial hasta el final del período de tratamiento de 2 semanas y 6 semanas.
    • Cambio de la media absoluta en el test de mantenimiento de la vigilia (MWT) entre la situación inicial hasta el final del período de tratamiento de 6 semanas.
    • Cambio en la media absoluta en la polisomnografía entre la situación inicial hasta el final del período de tratamiento de 6 semanas.
    Eficacia en la enfermedad de Parkinson (EP):
    • Cambio en la media absoluta en la escala MDS-UPDRS Parte III (control motor) entre la situación inicial hasta el final del período de tratamiento de 2 semanas y 6 semanas.
    • Cambio en la media absoluta en la escala de depresión BDI-II desde la selección / situación inicial hasta el final del período de tratamiento de 6 semanas.
    La seguridad de Bavisant en comparación con placebo se evaluará mediante la evaluación de lo siguiente:
    • Incidencias de Acontecimientos Adversos (AA), Acontecimientos Adversos Graves (AAG) y Acontecimientos Adversos de Especial Interés (AAEI) como dolor de cabeza, náuseas e insomnio
    • Incidencias en la exploración física, las constantes vitales y resultados de las pruebas analíticas (hematología y bioquímica).
    • Incidencias en los hallazgos de seguridad cardiovascular (presión arterial, frecuencia cardíaca, ECG incluyendo QT / QTc).
    • Incidencias en los hallazgos de la lámpara de hendidura.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline to the end of the 6-week treatment period.
    Desde el inicio hasta el final del período de tratamiento de 6 semanas.
    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 Yes
    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) 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 trial4
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    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
    Czech Republic
    Germany
    Italy
    Poland
    Spain
    United Kingdom
    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 years1
    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 years1
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 210
    F.4.2.2In the whole clinical trial 240
    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)
    All subjects will be contacted by phone 28 days after last IMP administration and the End of Study Visit to check their health or followup on Adverse Events. Subjects will return to standard treatment after the end of the study
    Todos los sujetos serán contactados por teléfono 28 días después de la última administración del IMP y la visita de fin de estudio para revisar su estado de salud o el seguimiento de acontecimientos adversos. Los sujetos volverán al tratamiento estándar después de finalizar en el estudio.
    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 Decision2017-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-05-28
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