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    Summary
    EudraCT Number:2010-021474-11
    Sponsor's Protocol Code Number:GE-001-013
    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:2010-10-14
    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 number2010-021474-11
    A.3Full title of the trial
    Ensayo fase 4 multicéntrico, aleatorizado, abierto y comparativo para evaluar los cambios en el diagnóstico de demencia y en la confianza en el diagnóstico tras la realización de DaTSCAN en pacientes con un diagnóstico dudoso de demencia con cuerpos de Lewy (posible DCL)
    A Multicentre, Randomised, Open-Label, Comparative Phase 4 Trial To Assess
    Changes in Dementia Diagnostic Category and Diagnostic Confidence After
    DaTSCAN Imaging in Subjects with an Uncertain Diagnosis of Dementia with
    Lewy Bodies (Possible DLB)
    A.4.1Sponsor's protocol code numberGE-001-013
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGE Healthcare Ltd. and its Affiliates
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 DATSCAN 74 MBq/ml solución inyectable
    D.2.1.1.2Name of the Marketing Authorisation holderGE HEALTHCARE LIMITED
    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 Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNIOFLUPANO 123I
    D.3.9.1CAS number 155798-07-5
    D.3.9.3Other descriptive nameIOFLUPANE (123I)
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number74
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Pacientes con posible demencia con cuerpos de Lewy (DCL) que pueden cumplir o no criterios de enfermedad de Alzheimer
    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
    Evaluar la influencia de las imágenes con DaTSCAN en el diagnóstico de demencia en sujetos con un diagnóstico dudoso de DCL (posible DCL).
    E.2.2Secondary objectives of the trial
    Demostrar que el uso de DaTSCAN aumenta la confianza en el diagnóstico en estos sujetos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1) Varones o mujeres de 55 años de edad en adelante.
    (2) Puntuación en el Mini examen del estado mental entre 10 y 26.
    (3) Sujetos con posible DCL según lo definido por los Criterios de Consenso Internacionales (demencia + 1 característica fundamental o 1 o más características indicativas), que pueden o no cumplir además los criterios de enfermedad de Alzheimer (EA).
    (4) El sujeto y un representante legal del sujeto (por ejemplo, el cuidador) son capaces y están dispuestos a cumplir los procedimientos del estudio y se obtiene el consentimiento informado firmado y fechado de cada uno de ellos.
    (5) El sujeto y un representante legal son capaces de cooperar con el protocolo y, en opinión del investigador, su participación no afectará negativamente a su tratamiento.
    (6) Podrán participar en el estudio mujeres estériles quirúrgicamente (sometidas a ooforectomía o histerectomía documentadas) o posmenopáusicas (más de un año sin menstruación) sin necesidad de realizar una prueba de embarazo en la selección.
    E.4Principal exclusion criteria
    (1) Diagnóstico clínico establecido/seguro de probable DCL o de una forma distinta de demencia.
    (2) Parkinsonismo > 1 año antes del comienzo de la demencia.
    (3) Síntomas extrapiramidales graves (Escala unificada de valoración de la enfermedad de Parkinson, parte 3 [UPDRS-III] > 30) o demencia debida a la enfermedad de Parkinson.
    (4) Vasculopatía significativa conocida/sospechosa con infartos múltiples o estratégicos o vasculopatía en el estriado/ganglios basales, demostrada preferiblemente en una exploración anterior por resonancia magnética (RM) o tomografía computarizada (TC). Si no es clínicamente viable una RM, se aceptará una TC cerebral realizada en los 6 meses previos a la visita basal.
    (5) Síntomas indicativos de atrofia multisistémica, degeneración corticobasal, parálisis supranuclear progresiva o enfermedad de Huntington.
    (6) Enfermedad mental grave persistente, como depresión, esquizofrenia y trastorno esquizoafectivo.
    (7) Hidrocefalia normotensiva.
    (8) Uso de cualquier medicamento del que se sabe o se sospecha que interacciona con la captación estriatal por competencia directa con la unión de DaTSCAN al DAT, siempre que no se haya suspendido durante un tiempo equivalente a 5 semividas como mínimo si el sujeto va a ser asignado al grupo de DaTSCAN (entre otros, anfetaminas, benztropina, buproprión, cocaína, mazindol, metilfenidato, fentermina y sertralina).
    (9) Presencia de insuficiencia renal o hepática moderada o grave.
    (10) Exposición laboral a la radiación igual o superior a 15 mSv al año.
    (11) Drogadicción pasada o actual.
    (12) Antecedentes de alcoholismo cuando el período de abstinencia es inferior a 3 años.
    (13) Hipersensibilidad a DaTSCAN o a alguno de sus componentes.
    (14) Inclusión previa en este estudio.
    (15) Mujeres embarazadas o lactantes o que tengan previsto quedarse embarazadas durante el estudio o en los 3 ciclos menstruales posteriores a la finalización del estudio. Las mujeres en edad fértil deberán obtener resultados negativos en una prueba de embarazo (con tira reactiva en orina) con gonadotropina coriónica humana beta (?-HCG) en la selección y antes de recibir la especialidad farmacéutica en investigación (EFI).
    (16) Participación en un estudio clínico de un medicamento no autorizado en los 30 días previos a la selección, o un radiofármaco no autorizado/autorizado en el tiempo equivalente a 5 periodos de semidesintegración radiactiva antes de la selección.
    (17) Enfermedad potencialmente mortal que suponga una esperanza de vida inferior a un año o antecedentes de un traumatismo médico o de una intervención quirúrgica significativos que, en opinión de los investigadores, impida al sujeto participar en el estudio.
    (18) Realización anterior de una SPECT con DaTSCAN u otra prueba de imagen funcional similar del sistema dopaminérgico presináptico o postsináptico (por ejemplo, PET con [18F] DOPA, 123I yodobenzamida).
    E.5 End points
    E.5.1Primary end point(s)
    Variación de la categoría diagnóstica entre el momento basal (V1) y la evaluación de la semana 8 (V2).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.1.1Randomised Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Sin especificar
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    El grupo de control sin tratamiento seguirá los mismos procedimientos, salvo que el SPECT con DaTSCA
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 Information not present in EudraCT
    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
    Last subject last visit
    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 months9
    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 months9
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Yes
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 174
    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 Decision2010-11-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-11-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-10-08
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