Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7294   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2014-000846-32
    Sponsor's Protocol Code Number:SELEIS
    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:2014-09-22
    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 number2014-000846-32
    A.3Full title of the trial
    EFFECT OF SEROTONIN AND LEVODOPA
    FUNCTIONAL RECOVERY IN PATIENTS WITH CEREBRAL INFARCTION
    EFECTO DE LA SEROTONINA Y LA LEVODOPA EN LA RECUPERACION FUNCIONAL DE PACIENTES
    CON INFARTO CEREBRAL.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EFFECT OF SEROTONIN AND LEVODOPA
    FUNCTIONAL RECOVERY IN PATIENTS WITH CEREBRAL INFARCTION
    EFECTO DE LA SEROTONINA Y LA LEVODOPA EN LA RECUPERACION FUNCIONAL DE PACIENTES
    CON INFARTO CEREBRAL.
    A.3.2Name or abbreviated title of the trial where available
    SELEIS
    SELEIS
    A.4.1Sponsor's protocol code numberSELEIS
    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 Privada Hospital Asil de Granollers
    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 Privada Hospital ASil de Granollers
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundació Privada Hospital Asil de Granollers
    B.5.2Functional name of contact pointUnitat de Recerca i Innovació
    B.5.3 Address:
    B.5.3.1Street AddressAv. Francesc Ribes s/n
    B.5.3.2Town/ cityGranollers
    B.5.3.3Post code08402
    B.5.3.4CountrySpain
    B.5.4Telephone number00349384250002825
    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 Citalopram Teva-Rimafar
    D.2.1.1.2Name of the Marketing Authorisation holderTeva Pharma, S.L.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 nameCitalopram
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCITALOPRAM
    D.3.9.1CAS number 59729-33-8
    D.3.9.4EV Substance CodeSUB07485MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.IMP: 2
    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 Sinemet
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp and Dohme de España, 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.3.1Product nameSinemet
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLevodopa
    D.3.9.2Current sponsor code55.866
    D.3.9.3Other descriptive nameLEVODOPA
    D.3.9.4EV Substance CodeSUB08468MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCarbidopa Monohydrate
    D.3.9.1CAS number 38821-49-7
    D.3.9.2Current sponsor code55.866
    D.3.9.3Other descriptive nameCARBIDOPA MONOHYDRATE
    D.3.9.4EV Substance CodeSUB21619
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Functional recovery in patients with cerebral infarction
    Recuperación funcional de pacientes con Infarto Cerebral
    E.1.1.1Medical condition in easily understood language
    Functional recovery in patients with cerebral infarction
    Recuperación funcional de pacientes con Infarto Cerebral
    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 17.0
    E.1.2Level PT
    E.1.2Classification code 10008118
    E.1.2Term Cerebral infarction
    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
    Evaluate at 12 months if treatment with drugs that increase the release of neurotransmitters in acute cerebral ischemia improves functional outcome compared with conventional treatment.
    Evaluar a los 12 meses si el tratamiento con fármacos que aumenten la liberación de neurotransmisores en la isquemia cerebral aguda mejora el pronóstico funcional, comparado con el tratamiento convencional.
    E.2.2Secondary objectives of the trial
    Secondary objectives assessed at medical discharge, 3, 6 and 12 months
    ? Compare the functional improvement with modified Rankin scale in each treatment group.
    ? Compare the neurological severity with the NIHSS scale in each group

    Secondary objectives assessed at medical discharge, 6 and 12 months
    ? Compare the improvement in depression measured with the Montgomery-Åsberg scale among the three groups
    ? Compare the cognitive improvement with the Mini Mental scale among the three groups
    Objetivos secundarios evaluados al alta, 3, 6 y 12 meses
    ? Comparar la mejoría funcional con la escala de Rankin modificada en cada grupo de tratamiento.
    ? Comparar la gravedad neurológica con la escala NIHSS en cada grupo

    Objetivos secundarios evaluados al alta, 6 y 12 meses
    ? Comparar la mejoría en la depresión valorado con la escala Montgomery-Åsberg entre los tres grupos
    ? Comparar la mejoría cognitiva con la escala Mini Mental entre los tres grupos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Patients with a first cerebral infarction with NIHSS 5-20 points
    ? Patients without aphasia to avoid their interference in the assessment of depression and cognitive impairment
    ? Patients with independent functional status previous to the cerebral infarction (mRS <3)
    ? Patients without cognitive impairment or prior depressive syndrome assessed by medical history with the patient and family.
    ? The assigned treatment was initiated within the first 5 days of cerebral infarction
    ? Pacientes con un primer infarto cerebral con NIHSS 5-20 puntos
    ? Pacientes sin afasia para evitar su interferencia en la valoración de la depresión y deterioro cognitivo
    ? Pacientes con estado funcional independiente previo al infarto cerebral (mRS <3)
    ? Pacientes sin deterioro cognitivo o síndrome depresivo previo evaluado por historia clínica con el paciente y familiares.
    ? El tratamiento asignado se iniciará dentro de los primeros 5 días del infarto cerebral
    E.4Principal exclusion criteria
    ? Patients with prior myocardial infarction or cerebral hemorrhage
    ? Patients with AIT
    ? Patients with aphasia
    ? History of prior cognitive impairment or depressive syndrome
    ? Patients with non-independent prior functional status mRS greater than or equal to 3
    ? Underlying disease with life expectancy of less than one year.
    ? Patient pretreatment with levodopa, an antidepressant or neuroleptic.
    ? Pacientes con infarto o hemorragia cerebral previa
    ? Pacientes con AIT
    ? Pacientes con afasia
    ? Antecedente de deterioro cognitivo o síndrome depresivo previo
    ? Pacientes con estado funcional previo no independiente mRS mayor o igual a 3
    ? Enfermedad de base con esperanza de vida inferior a un año.
    ? Paciente en tratamiento previo con levodopa, algún antidepresivo o neuroléptico.
    E.5 End points
    E.5.1Primary end point(s)
    Functional status, neurological severity, the degree of depression and cognitive impairment in each group compared to the control will be compared.
    Se comparará el estado funcional, la gravedad neurológica, el grado de depresión y de deterioro cognitivo de cada grupo comparado con el control.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 meses
    E.5.2Secondary end point(s)
    There are not secondary end points
    No hay variables secundarias
    E.5.2.1Timepoint(s) of evaluation of this end point
    Non Applicable
    No aplica
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    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
    Tratamiento convencional
    Conventional therapy
    E.8.2.4Number of treatment arms in the trial4
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    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: 72
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 168
    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 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 state240
    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 Decision2014-11-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-28
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu May 16 21:24:08 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA