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    Summary
    EudraCT Number:2015-004238-85
    Sponsor's Protocol Code Number:SPECT-IRBD
    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:2015-12-10
    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 number2015-004238-85
    A.3Full title of the trial
    Ictal brain SPECT in the premotor stage of Parkinson disease
    SPECT Ictal de perfusión cerebral en el periodo premotor de la enfermedad de Parkinson
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Brain SPECT in premotor stage of Parkinson disease
    SPECTen el periodo premotor de la enfermedad de Parkinson
    A.4.1Sponsor's protocol code numberSPECT-IRBD
    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 SponsorIDIBAPS
    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 supportMarató TV3
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Clínic
    B.5.2Functional name of contact pointServei Neurologia H. Clinic
    B.5.3 Address:
    B.5.3.1Street AddressVillarroel 170
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number0034932275400
    B.5.6E-mailjsantama@clinic.ub.es
    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 CERETEC (TM) Estabilizado
    D.2.1.1.2Name of the Marketing Authorisation holderGE Healthcare Bio-Sciences, S.A.U
    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 nameCeretec
    D.3.4Pharmaceutical form Powder for 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 INNCeretec
    D.3.9.1CAS number 100504-35-6
    D.3.9.3Other descriptive nameTECHNETIUM (99MTC) EXAMETAZIME
    D.3.9.4EV Substance CodeSUB15467MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mCi millicurie(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 disease
    Enfermedad de Parkinson
    E.1.1.1Medical condition in easily understood language
    Parkinson
    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 18.1
    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
    Identify differences in image over areas with hypo- and hyperperfusion during REM sleep in patients with IRBD regarding the images obtained in healthy volunteers
    Identificar diferencias de las áreas con hipo e hiperperfusión durante fase REM del sueño en pacientes con TCSRI con respecto a voluntarios sanos.
    E.2.2Secondary objectives of the trial
    Safety analysis
    ? Evaluación de la seguridad
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients:
    ? RBD diagnosis (International classification of Sleep disorders-2 criteria)
    ? Idiopatic RBD (non related with neurological diseases nor drug-treatment related,?)
    ? Patient can attend to visits

    Healthy volunteers:
    ? Subjects without associated active neurological disease
    ? Subjects without any relation with investigational team
    Grupo TCSR:
    ? Diagnóstico de TCSR según criterios de la International classification of Sleep disorders-2.
    ? TCSR de causa idiopática (no relación con fármacos, no relación con otras enfermedades neurológicas, etc?)
    ? Participante capaz de someterse a las pruebas y exploraciones que requiere el estudio.
    Grupo control (voluntarios sanos):
    ? Sujetos sin patología neurológica asociada activa.
    ? Sujetos sin relación biológica con el grupo de estudio.
    ? Participante capaz de someterse a las pruebas y exploraciones que requiere el estudio
    E.4Principal exclusion criteria
    ? Diagnosis of mild cognitive impairment or dementia
    ? Presence of parkinsonian symptom
    ? Serious medical pathology that can interfere with the performance of tests and clinical data.
    ? Hypersensitivity to the active substance or any of the excipients
    ? Subjects with low sodium diet.
    ? Participation in other clinical trial during the 30 days prior to the study .
    ?Pregnancy or breastfeeding
    ? Diagnóstico de deterioro cognitivo leve o demencia.
    ? Presencia de síntomas parkinsonianos.
    ? Patología médica grave que pueda interferir en la realización de las pruebas y en los datos clínicos.
    ? Hipersensibilidad al principio activo o alguno de los excipientes.
    ? Sujetos con dieta baja en sodio.
    ? Participación en un ensayo clínico durante el período de 30 días previo a la realización del estudio.
    ? Embarazo o lactancia
    E.5 End points
    E.5.1Primary end point(s)
    Identification of brain areas that are hyper and hypo activated during REM phase (z score SISCOM software)
    Imagen: identificación de áreas del cerebro que están hiper e hipoactivadas durante fase REM (z score software SISCOM)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline (day of SPECT)
    Basal (día de SPECT)
    E.5.2Secondary end point(s)
    number of adverse events (AE)
    number of serious adverse events (SAE)
    number of adverse reactions (AR)
    number of serious adverse reactions (SAR)
    number of unexpected serious adverse reactions (SUSAR)
    number of patients with AE,SAE, AR, SAR and SUSAR
    número de acontecimientos adversos (AA)
    Número de acontecimientos adversos graves (AAG)
    Número de reacciones adversas (RA)
    Número de reacciones adversas graves (RAG)
    Número de reacciones adversas graves e inesperadas (RAGI)
    Número de pacientes con AA, AAG,RA, RAG y RAGI
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 week after treatment
    1 semana post tratamiento
    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 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) 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 No
    E.8.1.2Open No
    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 Yes
    E.8.2.3.1Comparator description
    el mismo tratamiento se administra a 15 pacientes y 15 voluntarios sanos como grupo control
    same treatment is administered to 15 patients and to 15 healthy volunteers as a control group
    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
    LVLS
    última visita último paciente
    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 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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state30
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-01-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-27
    P. End of Trial
    P.End of Trial StatusCompleted
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