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    Summary
    EudraCT Number:2014-001014-25
    Sponsor's Protocol Code Number:FBB-DBS-2014
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-07-15
    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 number2014-001014-25
    A.3Full title of the trial
    Brain Amyloid-Beta burden as per florbetaben (Neuraceq) pet and cognitive outcomes after deep brain stimulation in Parkinsin's disease
    Carga de amiloidosis cerebral medida por PET con Florbetaben (Neuraceq) y pronóstico cognitivo bajo estimulación cerebral profunda en la enfermedad de Parkinson
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Brain amyloid beta burden as per florbetaben PET
    Medición de carga amiloidosis cerebral con técnica PET y florbetaben
    A.4.1Sponsor's protocol code numberFBB-DBS-2014
    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 SponsorFundació Clínic per la Recerca Biomèdica
    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 supportFundació Clínic per a la Recerca Biomèdica
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCTU CLINIC
    B.5.2Functional name of contact pointSara Varea
    B.5.3 Address:
    B.5.3.1Street AddressMallorca 183
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number00349322754003343
    B.5.5Fax number0034932279877
    B.5.6E-mailsvarea@clinic.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 Neuraceq
    D.2.1.1.2Name of the Marketing Authorisation holderPiramal Imaging GmbH
    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.3.1Product nameNeuraceq
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFLORBETABEN (18F)
    D.3.9.1CAS number 902143-01-5
    D.3.9.2Current sponsor codePiramal Imaging GmbH
    D.3.9.4EV Substance CodeSUB119774
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/mg megabecquerel(s)/milligram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 Yes
    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
    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.1.2 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
    Assess safety of FBB PET Brain scan pre surgery in Parkinson diseade (PD) patients
    Evaluar la seguridad de PET cerebral prequirúsgico con florbetaben en pacientes con Enfermedad de Parkinson (EP)
    E.2.2Secondary objectives of the trial
    Assess the proportion of FBB PET positive scans at baseline to the cut off in our reference population
    compare longitudinal changes in global, motor,cognitive and behavioural outcomes
    comparing progressing to dementia patients if any
    - comparing diferences in FBBPET between patients with worsening vs who doesn't
    Evaluar la proporción de PET con FBB positivos en basal con respecto a nuestra población de referencia
    -Comparar cambios en variables globales, motoras, cognitivas y de comportamiento en aquellos que progresan a demencia si los hubiera
    - comparar diferencias en PET con FBB entre pacientes que empeoran y aquellos que no
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. PD patients aged 60 to 69 years,
    2. Motor fluctuations refractory to the best medical treatment that have led to the indication of STN-DBS;
    3. Commitment to participate and complete all study procedures according to the principal investigator;
    4. Voluntary fulfilment and signature of the study Informed Consent Form.
    1. Pacientes con EP entre 60 y 69 años,
    2. Con fluctuaciones motoras resistentes al mejor tratamiento médico disponible que tienen indicada cirugía STN-DBS;
    3. Pacientes comprometidos a participar y capaces de completar todos los procedimientos del estudio que le ha indicado el investigador principal;
    4. Pacientes que otorgan consentimiento mediante la firma del formulario de Consentimiento informado
    E.4Principal exclusion criteria
    1. Subjects not eligible for STN-DBS (due to presence of one or more exclusion criteria for STN-DBS including the possibility of a diagnosis different to PD, such as any of the atypical parkinsonisms) or likely not to be able to complete the study;
    2. PD-related dementia according to the MDS definition of PD-dementia;
    3. Any major disease or history of a major disease, especially hepatobilliar disease (AST /ALT ≥ 5 x ULN) or advanced renal insufficiency (creatinine ≥ 2 x ULN);
    4. Current or previous history of alcohol abuse or epilepsy;
    5. Allergy to FBB or any of its constituents;
    6. Multiple drug allergies and/or previous history of contrast allergy;
    7. Pregnancy or breast feeding or planned pregnancy during the study period;
    8. Any disease or history of disease which, in the opinion of the investigator, can cause disturbance of brain function (e.g. vitamin B12 or folic acid deficiency, disturbed thyroid function);
    9. Evidence for any other neurological or psychiatric disease.
    1. Sujetos no elegibles para realización de cirugía STN-DBS (por uno o varios criterios que impidan la realización de cirugía STN-DBS incluyendo la posibilidad de un diagnóstico diferente de EP como alguno de los parkisonismos atípicos) o incapaces de completar el estudio;
    2. Demencia relacionada con EP según definición de demencia en EP de la MDS ;
    3. Cualquier Enfermedad relevante o historia de Enfermedad relevante, especialmente Enfermedad hepatobiliar (AST /ALT ≥ 5 x Límite superior de normalidad (ULN)) o insuficiencia renal avanzada (creatinina ≥ 2 x ULN);
    4. Historia previa o actual de abuso de alcohol o epilepsia;
    5. Alergia conocida a FBB o cualquiera de sus componentes;
    6. Alergias multiples a medicamentos y/o alergia previa a contraste;
    7. Embarazo o lactancia durante el estudio;
    8. Cualquier enfermedad o historia de Enfermedad que, a criterio del investigador, pudiera alterar la function cerebral (ej déficit de Vitamina B12 o ácido fólico, función tiroidea alterada);
    9. Evidencia de cualquier Enfermedad neurológica o psiquiátrica.
    E.5 End points
    E.5.1Primary end point(s)
    - Incidence of adverse events of a single dose of FBB followed by PET scan in PD patients about to undergo DBS.
    - Proportion of + FBB PET scans at baseline
    - Proportion of patients with clinical important differences for each outcome measure including the proportion of patients progressing to dementia at 18 months (if any).
    - Incidencia de acontecimientos adversos (AA) tras una dosis única de FBB seguida de un scan PET en pacientes con EP un mes antes de intervención quirúrgica STN‐DBS;
    - Proporción de PET‐FBB positivos en la visita basal;
    - Proporción de pacientes con diferencias clinicamente relevantes en cada una de las variables de análisis incluyendo la proporción de pacientes que progresan a demencia a los 18 meses.
    E.5.1.1Timepoint(s) of evaluation of this end point
    18 months
    18 meses
    E.5.2Secondary end point(s)
    1. Significant correlations of longitudinal changes in motor, neuropsychological, and neuropsychiatric scores with SUVRs of baseline FBB-PET.
    2. Significant differences in regional SUVR between PD patients experiencing motor, neuropsychological or neuropsychiatric worsening at follow-up and those remaining stable or getting better.
    3. Cortical pattern of amyloid deposition in PD patients upon visual and quantitative examination
    1. Diferencias en el ratio del valor estándar de captación (SUVR)
    clínicamente
    relevante en las escalas motor (MDS‐UPDRS), cognitivo (PD‐CRS), o
    conductual (NPI)
    2. Diferencias en el ratio del valor estándar de captación (SUVR) regional de FBB PET prequirúrgicos en pacientes con la enfermedad de Parkinson que experimentan empeoramiento clínico global
    relevante (CGI), motor (MDS‐UPDRS), cognitivo (PD‐CRS), o conductual (NPI) durante el seguimiento frente a los que no experimentan un cambio clínicamente relevante (es decir, se mantiene estable o mejorando);
    2. La correlación de las variables motoras, cognitivas y conductuales de los SUVRs en FBB‐PET pre‐quirúrgico basalmente y a los 18 meses de seguimiento, así como su cambio longitudinal;
    3. Patrón cortical de los depósitos de amiloide en pacientes con Parkinson según FBB PET (tanto mediante examen visual como semicuantitativo y por cuantificación).
    E.5.2.1Timepoint(s) of evaluation of this end point
    18 months
    18 meses
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 trial1
    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
    dfwesd
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state40
    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
    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 Decision2016-07-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-09
    P. End of Trial
    P.End of Trial StatusOngoing
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