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    Summary
    EudraCT Number:2016-000679-25
    Sponsor's Protocol Code Number:IIBSP-CAN-2016-16
    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:2016-03-18
    Trial 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 number2016-000679-25
    A.3Full title of the trial
    A prospective, randomized, double-blind and placebo-controlled, parallel group, phase II study to compare the efficacy and safety of candesartan versus placebo on cognitive impairment associated with Parkinson?s disease. Exploratory study.
    Ensayo clínico aleatorizado, doble ciego y controlado por placebo, de evaluación de la eficacia y la seguridad del candesartán versus placebo en el deterioro cognitivo leve asociado a la enfermedad de Parkinson. Estudio exploratorio
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study for the assessment of security of candesartan in Parkinson?s disease population and its potential benefit in cognitive impairment associated to Parkinson?s disease.
    Estudio clínico para evaluar la seguridad de candesartan en pacientes con enfermedad de Parkinson y su beneficio potencial en el deterioro cognitivo asociado
    A.4.1Sponsor's protocol code numberIIBSP-CAN-2016-16
    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 SponsorINSTITUT DE RECERCA HSCSP
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportInstitut de Recerca HSCSP
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recerca HSCSP
    B.5.2Functional name of contact pointUICEC Sant Pau
    B.5.3 Address:
    B.5.3.1Street AddressSant Antoni Maria Claret 167
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08025
    B.5.3.4CountrySpain
    B.5.4Telephone number34935537636
    B.5.5Fax number34935537812
    B.5.6E-mailepenag@santpau.cat
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Parapres
    D.2.1.1.2Name of the Marketing Authorisation holderAlmirall, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. Security: control thorough laboratory tests, vital signs including blood pressure and heart rate, and physical examination findings including electrocardiogram.

    2. Efficacy: assessed thorough analysis of Parkinson?s Disease-Cognitive Rating Scale change from baseline to 24 weeks after treatment with candesartan, compared to placebo.
    1. Seguridad: Evaluar la seguridad del candesartán a bajas dosis en pacientes con deterioro cognitivo leve asociado a enfermedad de Parkinson (EP-DCL), a través de la medición de las cifras de tensión arterial, frecuencia cardíaca y peso, mediante la realización periódica de analíticas y electrocardiogramas, y mediante la administración de la escala Unified Parkinson?s Disease Rating Scale (UPDRS) III, comparado con placebo.

    2. Eficacia: Evaluar el potencial efecto neuroprotector del candesartán en pacientes con EP-DCL, mediante el análisis del cambio en la puntuación de la escala Parkinson?s Disease-Cognitive Rating Scale (PD-CRS), en un período de 6 meses, comparado con placebo.
    E.2.2Secondary objectives of the trial
    Secondary objectives are analysis of changes in serum biomarkers of neuroinflammation as well as an assessment of the effect of candesartan in executive function, functional, mood and motor scales compared to placebo
    - Evaluar el potencial efecto neuroprotector del candesartán en las funciones ejecutivas de los pacientes con EP-DCL, mediante el análisis del cambio en la puntuación de la escala Behavioural Assessment of Dysexecutive Function Scale (BADS-RS, BADS-KS, BADS-ZM y BADS-6E) y el test Tower of London (ToL), en un período de 6 meses, comparado con placebo.

    - Evaluar el potencial efecto del candesartán sobre la capacidad funcional de los pacientes con EP-DCL mediante el análisis del cambio en la puntuación de las escalas Parkinson?s Disease-Cognitive Functional Rating Scale (PD-CFRS), Schwab & England scale (S&E) y The 39-item Parkinson's Disease Questionnaire (PDQ-39).

    - Controlar posibles cambios de puntuación en ansiedad, depresión y apatía mediante las escalas Hospital Anxiety and Depression Scale (HADS) y Starkstein Apathy Scale (AS).

    - Evaluar el efecto del candesartán sobre biomarcadores sanguíneos de neuroinflamación (Ac anti AT1R y AGEs).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a. Patient able to understand, sign, and date the written voluntary informed consent form at screening visit prior to any protocol-specific procedures.
    b. Outpatients of both genders in ages between 40 and 80 years.
    c. Patients diagnosed of Parkinson?s disease (Movement Disorder Society PD Criteria)
    d. Patients with a Hoehn and Yahr stage I-III
    e. Patients diagnosed of mild cognitive impairment associated to Parkinson?s Disease (PD-MCI criteria based on Movement Disorder Society task force guidelines).
    f. Patients with a Montreal Cognitive Assessment (MoCA) rating scale score 20-25 inclusive.
    g. Patients diagnosed of Parkinson?s disease with stable dopaminergic treatment in the last 4 weeks.
    h. Patient able and willing to comply with study procedures as per protocol.
    i. Computerized tomography (CT) or magnetic resonance imaging (MRI) in the last 18 months compatible with the diagnosis of Parkinson?s disease.
    a. Paciente capaz de entender, firmar y fechar el consentimiento informado escrito en la visita basal, de forma previa a la aleatorización.
    b. Pacientes ambulatorios de ambos géneros entre 40 y 80 años.
    c. Pacientes diagnosticados de enfermedad de Parkinson (Movement Disorder Society PD Criteria)
    d. Pacientes con estadio Hoehn y Yahr entre I-III.
    e. Pacientes diagnosticados de deterioro cognitivo leve asociado a enfermedad de Parkinson (PD-MCI criteria basados en la Movement Disorder Society task force guidelines).
    f. Pacientes con una puntuación en la escala de Evaluación Cognitiva de Montreal (MoCA) entre 20 y 25, ambos inclusive.
    g. Pacientes diagnosticados de enfermedad de Parkinson con tratamiento dopaminérgico estable en las últimas 4 semanas.
    h. Paciente capaz y dispuesto a cumplir las visitas del estudio tal y como se detallan en el protocolo.
    i. Tomografía computerizada (TC) o resonancia magnética (RM) compatible con el diagnóstico de enfermedad de Parkinson realizada en los últimos 18 meses.
    E.4Principal exclusion criteria
    a. Illiterate patient
    b. Marked visual impairing or hearing loss.
    c. History of cardiac, hematologic, hepatic, renal, pancreatic, metabolic, respiratory, gastrointestinal, endocrinologic, or neurologic system or a tumor that is clinically significant for their participation in the study.
    d. Presence of significant motor complications (moderate or severe wearing off defined as score >1 on item 42 of UPDRS part IV) or disabling dyskinesia (defined as score ? 1 on item 36 of UPDRS part IV).
    e. History of DBS surgery.
    f. Patient with a diagnosis of PD Dementia (probable, possible) according to the Clinical Diagnostic Criteria for Dementia Associated with PD.
    g. Patients with active psychosis or major hallucinations, severe depression or delirium.
    h. Patients with symptomatic hypotension, hypovolemia or contraindications for taking antihypertensive medications.
    i. Patients whose renal function depends on Renin Angiotensin System:
    - Patients with cardiac failure class III or IV of the NYHA classification.
    - Patients with unilateral or bilateral renal artery stenosis.
    j. Patients taking angiotensine-receptor blockers, angiotensin-converting enzyme inhibitors or potassium-sparing diuretics.
    k. Patients previously treated with candesartan.
    l. Patients with hereditary galactose intolerance, glucose or galactose malabsortion
    m. Patients taking lithium.
    n. Patients taking acetilcholinesterase inhibitors, anticholinergic medication or dopamine receptor blockers.
    o. Patients who were on experimental treatments in the last 2 months previous to selection period.
    p. Patients presenting with one of the following conditions:
    - Life expectancy < 6 months
    - Any severe and/or uncontrolled medical condition
    q. Patients with history of poor compliance or history of drug/alcohol abuse, or current drug/alcohol abuse that might interfere with the ability to comply with the study protocol or give informed consent
    r. Pregnancy or breastfeeding.
    s. Patients with evidence of severe vascular pathology or white matter diffuse involvement in CT or MRI.
    a. Paciente analfabeto.
    b. Paciente con afectación severa de la visión o audición.
    c. Historia de enfermedad cardíaca, hematológica, hepática, renal, pancreática, metabólica, respiratoria, gastrointestinal, endocrinológica, neurológica o neoplásica, que sea clínicamente relevante para su participación en el estudio.
    d. Presencia de complicaciones motoras relevantes (wearing off moderado o severo definido como una puntuación >1 del item 42 de la parte IV del UPDRS) o discinesias incapacitantes (definidas como una puntuación >1 en el item 36 de la parte IV del UPDRS).
    e. Historia de cirugía de estimulación cerebral profunda.
    f. Pacientes con diagnóstico de demencia (posible o probable) asociada a la enfermedad de Parkinson, según el Clinical Diagnostic Criteria for Dementia Associated with PD.
    g. Pacientes con psicosis activa o alucinaciones mayores, depresión severa o delirio.
    h. Pacientes con hipotensión sintomática, hipovolemia o contraindicaciones para la toma de medicación antihipertensiva.
    i. Pacientes cuya función renal dependa del sistema renina-angiotensina:
    o Pacientes con insuficiencia cardíaca clase III o IV de la clasificación NYHA.
    o Pacientes con estenosis renal uni o bilateral conocida.
    j. Pacientes que estén tomando ARAs, IECAs o diuréticos ahorradores de potasio.
    k. Pacientes previamente tratados con candesartán.
    l. Pacientes con intolerancia hereditaria a la galactosa, glucosa o malabsorción de galactosa.
    m. Pacientes que estén tomando litio.
    n. Pacientes que estén tomando inhibidores de la acetilcolinesterasa, medicación anticolinérgica o antagonistas de los receptores de dopamina.
    o. Pacientes que estuvieran bajo tratamiento experimental en los 2 meses previos al período de selección.
    p. Pacientes con cualquiera de las siguientes situaciones:
    o Esperanza de vida inferior a 6 meses.
    o Cualquier condición médica severa o no controlada.
    q. Pacientes con historia de bajo cumplimiento terapéutico o abuso de drogas/alcohol que pueda interferir con la capacidad del paciente para cumplir el protocolo del estudio o dar el consentimiento informado.
    r. Embarazo o lactancia.
    s. Pacientes con evidencia de patología vascular severa o alteración relevante de sustancia blanca por TC o RM.
    E.5 End points
    E.5.1Primary end point(s)
    Absolute change in Parkinson?s disease-Cognitive Rating Scale score
    Cambio absoluto en la Parkinson?s Disease-Cognitive Rating Scale (PD-CRS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks
    24 semanas
    E.5.2Secondary end point(s)
    - Absolute change in executive function scales: Behavioral Assessment of Dysexecutive Syndrome (BADS) and Tower of London (ToL), from baseline to week 24.

    - Absolute change in functional scales: Parkinson?s disease-Cognitive Functional Rating Scale, Schwab & England and 39-item Parkinson's Disease Questionnaire scores, from baseline to week 24.

    - Absolute change in mood scales: Starkstein Apathy Scale (AS) score and Hospital Anxiety and Depression Scale (HADS) score, from baseline to week 24.

    - Absolute change in motor state assessed by Unified Parkinson?s disease Rating Scale-part III, from baseline to week 24.

    - Absolute change in serum biomarkers: advanced glycosylation end products and AT1R antibodies, from baseline to week 24.
    Cambio en las siguientes escalas:
    - Behavioral Assessment of Dysexecutive Syndrome (BADS) y Tower of London (ToL).
    - Parkinson?s disease-Cognitive Functional Rating Scale, Schwab & England y 39-item Parkinson's - Disease Questionnaire scores.
    Starkstein Apathy Scale (AS) score and Hospital Anxiety and Depression Scale (HADS) score.
    - Unified Parkinson?s disease Rating Scale-part III
    - Cambio en los biomarcadores séricos: productos finales de glicosilación avanzada, y anticuerpos AT1R
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 weeks
    24 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 Yes
    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) 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Ultima visita del último sujeto
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months20
    E.8.9.1In the Member State concerned days
    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: 28
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 28
    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 state56
    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)
    Expected normal treatment of the condition
    Tratamiento habitual de la patología
    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 Decision2016-05-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-25
    P. End of Trial
    P.End of Trial StatusCompleted
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