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    The EU Clinical Trials Register currently displays   43925   clinical trials with a EudraCT protocol, of which   7306   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2015-004656-22
    Sponsor's Protocol Code Number:IIBSP-THK-2015-77
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-02-24
    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 number2015-004656-22
    A.3Full title of the trial
    Pilot study of the [18F]THK-5351 positron emission tomography (PET) tracer in different tauopathies.
    ESTUDIO PILOTO DEL TRAZADOR DE TOMOGRAFÍA POR EMISIÓN DE POSITRONES (PET) PARA TAU [18F]THK-5351 EN PACIENTES CON DIFERENTES TAUPATÍAS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of a new positron emission tomography (PET) tracer for the study of neurodegenerative conditions characterized by the cerebral accumulation of the protein tau.
    ESTUDIO PARA EVALUAR UN NUEVO RADIOFÁRMACO PARA EL ESTUDIO DE ENFERMEDADES NEURODEGENERATIVAS CARACTERIZADAS POR LA ACUMULACIÓN CEREBRAL DE PROTEÍNA TAU
    A.4.1Sponsor's protocol code numberIIBSP-THK-2015-77
    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 number34935537634
    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 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 name[18F]THK-5351
    D.3.2Product code [18F]THK-5351
    D.3.4Pharmaceutical form Radiopharmaceutical precursor
    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 INN[18F]THK-5351
    D.3.9.2Current sponsor code[18F]THK-5351
    D.3.9.3Other descriptive name[18F]-(S)-6-[(3-Fluoro-2-hydroxy)propoxy]-2-(2-Methylaminopyrid-5-yl)-quinoline ([18F]THK-5351)
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number185
    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
    Taupatías
    Taupatías
    E.1.1.1Medical condition in easily understood language
    Neurodegenerative conditions characterized by the cerebral accumulation of the protein tau
    Enfermedades neurodegenerativas caracterizadas por la acumulación cerebral de proteína tau
    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
    To assess the efficacy of [18F]THK-5351 to detect Tau pathology in patients with AD, DS related dementia, nfPPA, bvFTD, PSP and CBD.
    Obtener información preliminar sobre la eficacia de [18F]THK-5351 en la detección de patología tau en la EA esporádica y asociada al SD, en la vcDFT, en los S-T4R así como en la nfaAPP.
    E.2.2Secondary objectives of the trial
    To evaluate the safety of [18F]THK-5351 in healthy subjects, as well as in patients with AD, DS related dementia, nfPPA, bvFTD, PSP and CBD.
    Evaluar la seguridad de [18F]THK-5351 en sujetos sanos, sujetos con EA esporádica, en la vcDFT, en los S-T4R, en la nfaAPP y en sujetos con síndrome de Down.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria for patients: (1) Men and women over eighteen years-old; (2) evaluated at the Memory unit of the Hospital de la Santa Creu i Sant Pau; (3) that meet current clinical criteria for Alzheimer disease dementia, mild cognitive impairment due to Alzheimer disease, DS related dementia, nfPPA, bvFTD, PSP and CBD; (4) and given written informed consent.

    Inclusion criteria for healthy controls: (1) Men and women over eighteen years old; (2) currently enrolled in other clinical studies of the Memory unit at the Hospital de la Santa Creu i Sant Pau; (3) without cognitive complaints; (4) a normal performance on neuropsychological evaluation (adjusted by age and education); (5) and given written informed consent.
    Criterios de inclusión para los pacientes: (1) Hombres y mujeres de más de dieciocho años de edad; (2) evaluados en la unidad de memoria del Hospital de la Santa Creu i Sant Pau; (3) que cumplen con los criterios clínicos actuales para enfermedad de Alzheimer , deterioro cognitivo leve debido a la enfermedad de Alzheimer, demencia relacionada con la DS, nfPPA, bvFTD, PSP y el CDB; (4) consentimiento informado por escrito.

    Los criterios de inclusión para los controles sanos: (1) Hombres y mujeres de más de dieciocho años de edad; (2) actualmente participando en otros estudios clínicos de la unidad de memoria en el Hospital de la Santa Creu i Sant Pau; (3) sin quejas cognitivas; (4) un desempeño normal en la evaluación neuropsicológica (ajustado por edad y educación); (5) consentimiento informado por escrito.
    E.4Principal exclusion criteria
    General exclusion criteria: (1) Non-compliance of inclusion criteria; (2) Diagnosis of major depression; (3) Previous stroke; (4) Inability to perform lumbar puncture, magnetic resonance imaging or neuropsychological evaluation.
    (1)No cumplir los criterios de inclusión (2) diagnóstico de depresión mayor (3) ictus previo (4) imposibilidad de realizar punción lumbar, RMN, o evaluación neuropsicológica.
    E.5 End points
    E.5.1Primary end point(s)
    Standarized uptake value ratios (SUVR) of generated images on PET-TC (Philips Gemini TF or en Philips Vereos Digital) during the first 90 minutes following the administration of [18F]THK-5351.
    Standardized uptake value ratios (SUVR) de las imágenes generadas con [18F]THK-5351 (0-90 min)
    E.5.1.1Timepoint(s) of evaluation of this end point
    90 minutes
    90 minutos
    E.5.2Secondary end point(s)
    Adverse effects will be systematically evaluated and registered during the first 24 hours after the administration of the tracer.
    Aparición de acontecimientos adversos
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 hours
    24 horas
    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 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 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
    LVLS
    UVUS
    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 months12
    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: 60
    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 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 state80
    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
    Tratamiento habitual
    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 Decision2017-10-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-05-28
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