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    Summary
    EudraCT Number:2014-003123-22
    Sponsor's Protocol Code Number:JCS-CBG-2014-01
    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:2014-11-05
    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 number2014-003123-22
    A.3Full title of the trial
    "Randomized clinical trial with two parallel groups, double-blind, placebo-controlled trial to investigate whether administration of CBG000592 (riboflavin/vitamin B2) in patients with acute ischemic stroke causes a reduction of glutamate-mediated excitotoxicity"
    "Ensayo clínico aleatorizado, con dos grupos paralelos, doble ciego y controlado con placebo para investigar si la administración de CBG000592 (riboflavina/vitamina B2) en pacientes con ictus isquémico agudo provoca una reducción de excitoxicidad mediada por glutamato?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to see if riboflavin reduces neuronal damage in patients with acute ischemic stroke
    Estudio para comprobar si la riboflavina reduce el daño neuronal en pacientes con ictus isquémico agudo
    A.4.1Sponsor's protocol code numberJCS-CBG-2014-01
    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 SponsorJosé Castillo Sanchez
    B.1.3.4CountrySpain
    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 supportSERGAS (Innova Saúde, Fondo Tecnológico 2007-13, cofinanciado FEDER)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación Ramón Domínguez
    B.5.2Functional name of contact pointFundación Ramón Domínguez
    B.5.3 Address:
    B.5.3.1Street AddressEdif. D, 1º p. Travesía da Choupana, s/n
    B.5.3.2Town/ citySantiago de Compostela
    B.5.3.3Post code15706
    B.5.3.4CountrySpain
    B.5.4Telephone number+34981955041
    B.5.5Fax number+34981955168
    B.5.6E-mailcaiber.chus@sergas.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 Vitamin B2 Streuli®
    D.2.1.1.2Name of the Marketing Authorisation holderStreuli®
    D.2.1.2Country which granted the Marketing AuthorisationSwitzerland
    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 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 INNRIBOFLAVIN SODIUM PHOSPHATE
    D.3.9.1CAS number 130-40-5
    D.3.9.2Current sponsor codeCBG000592
    D.3.9.4EV Substance CodeSUB04238MIG
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute ischemic stroke
    Ictus isquémico agudo
    E.1.1.1Medical condition in easily understood language
    Ictus
    Ictus
    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
    Assess whether CBG000592 (riboflavin/vitamin B2) administration in patients with acute ischemic stroke induces a reduction of serum glutamate concentration.
    Evaluar si la administración de CBG000592 (riboflavina/vitamina B2) en pacientes con ictus isquémico agudo induce una reducción de la concentraión de glutamato sérico.
    E.2.2Secondary objectives of the trial
    1. Study whether patients with acute ischemic stroke and treated with CBG000592 (riboflavin) have lower average stay than those who receiving placebo.
    2. Study if patients with acute ischemic stroke and were treated with CBG000592 (riboflavin) have a higher percentage of clinical improvement (basal-high) than those who receiving placebo.
    3. Consider whether patients with acute ischemic stroke and treated with CBG000592 (riboflavin) have a better functional outcome than those who receiving placebo.
    4. Investigate the variations of serum glutamate levels among acute ischemic stroke patients treated with CBG000592 (riboflavin) or placebo.
    5. Explore whether the prognosis of patients receiving CBG00592 (riboflavin) and have no stroke is not worse than those treated with placebo.
    6. Assess if CBG000592 (riboflavin) administration in patients with clinical suspicion of stroke, administered within the first three hours of onset is safe.
    1. Estudiar si pacientes con ictus isquémico agudo y tratados con CBG000592 (riboflavina) tienen una menor estancia media que los que reciben placebo.
    2. Estudiar si pacientes con ictus isquémico agudo y tratados con CBG000592 (riboflavina) tienen un mayor porcentaje de mejoría clínica (basal-alta) que los que reciben placebo.
    3. Estudiar si pacientes con ictus isquémico agudo y tratados con CBG000592 (riboflavina) tienen un mejor pronóstico funcional que los que reciben placebo.
    4. Investigar las variaciones de las curvas séricas de glutamato entre los pacientes con ictus isquémico agudo que recibieron CBG000592 (riboflavina) o placebo.
    5. Explorar si el pronóstico de los pacientes que reciben CBG00592 (riboflavina) y no tienen infarto cerebral no es peor que los tratados con placebo.
    6. Evaluar si la administración de CBG000592 (riboflavina) en pacientes con sospecha clínica de ictus, administrado dentro de las tres primeras horas de evolución es seguro.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients older than 18 years, both men and women.
    - Patient or legal representative able to understand and sign the informed consent.
    - Patients with suspected stroke within 3 hours of onset.
    - Pacientes mayores de 18 años, tanto hombres como mujeres.
    - Paciente o representante legal capaz de entender y firmar el consentimiento informado.
    - Pacientes con sospecha de ictus de menos de 3 horas de evolución.
    E.4Principal exclusion criteria
    - Women of childbearing age, with potential for pregnancy or breastfeeding.
    - Patients with a score ? 2 point 1a in the NIHSS scale.
    - Scale pre-stroke modified Rankin ? 2.
    - Inability to prior testing image needed for the study.
    - previous disorders that may interfere with the interpretation of neurological scales.
    - Treatment with probenecid, tricyclic antidepressants, phenothiazines, streptomycin, erythromycin, tirotricina, tetraciclines and carbomycin, at the time of inclusion.
    - Mujeres en edad fértil, con riesgo potencial de embarazo o amamantando.
    - Pacientes con puntuación en el punto 1a ? 2, en la escala NIHSS.
    - Escala Rankin modificada previa al ictus ? 2.
    - Imposibilidad previa de realización de pruebas de imagen necesarias para el estudio.
    - Desórdenes previos que puedan interferir en la interpretación de las escalas neurológicas.
    - A tratamiento con probenecid, antidepresivos tricíclicos, fenotiazidas, estreptomicina, eritromicina, tirotricina, carbomicina y tetraciclina en el momento de la inclusión.
    E.5 End points
    E.5.1Primary end point(s)
    Difference between serum glutamate concentration from basal (prior to medication infusion) and levels at 3 ± 1 and 6 ± 1 hours, from administered medication, including branch CBG000592 (riboflavin/vitamin B2) and placebo.
    Diferencia entre los niveles de glutamato sérico obtenidos de modo basal (previo a la infusión de la medicación) con los niveles a las 3±1 y las 6±1 horas de administrada la medicación, entre la rama de CBG000592 (riboflavina/vitamina B2) y de placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline (before drug administration) and at 3±1 and at 6±1 hours
    Basal (antes de la administración de la medicación) y a las 3±1 y 6±1 horas
    E.5.2Secondary end point(s)
    - To study the average length of stay in patients with acute ischemic stroke: difference in days, between patient arrival and the patient's discharge, between the two treatment arms.
    - To study the rate of clinical improvement in patients with acute ischemic stroke: clinical improvement according to the formula: (NIHSSbasal-NIHSSalta) / NIHSSbasal x 100 and compared between the two treatment arms.
    - To study the functional outcome in patients with acute ischemic stroke: modified Rankin scale at 90 days, between two treatment arms.
    - Variations of serum glutamate curves in patients with acute ischemic stroke between two branches: all concentrations of serum glutamate.
    - To explore the prognosis of patients without stroke, evaluating modified Rankin scale at 90 days.
    - Safety management: measuring adverse events throughout the study.
    1. Estudiar si los pacientes con ictus isquémico agudo y tratados con CBG000592 (riboflavin/vitamin B2) tienen una menor estancia media que los que reciben placebo.
    2. Estudiar si los pacientes con ictus isquémico agudo y tratados con CBG000592 (riboflavin/vitamin B2) tienen un mayor porcentaje de mejoría clínica (basal-alta) que los que reciben placebo.
    3. Estudiar si los pacientes con ictus isquémico agudo y tratados con CBG000592 (riboflavin/vitamin B2) tienen un mejor pronóstico funcional que los que reciben placebo.
    4. Investigar las variaciones de las curvas séricas de glutamato entre los pacientes con ictus isquémico agudo que recibieron CBG000592 (riboflavin/vitamin B2) o placebo.
    5. Explorar si el pronóstico de los pacientes que reciben CBG00592 (riboflavin/vitamin B2) y no tienen infarto cerebral no es peor que los tratados con placebo.
    6. Evaluar si la administración de CBG000592 (riboflavin/vitamin B2) en pacientes con sospecha clínica de ictus, administrado dentro de las tres primeras horas de evolución es seguro.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Aaverage length of stay in patients with acute ischemic stroke: difference in days, between patient arrival and the patient's discharge, between the two treatment arms.
    - Rate of clinical improvement in patients with acute ischemic stroke: clinical improvement according to the formula: (NIHSSbasal-NIHSSdischarge) / NIHSSbasal x 100 and compared between the two treatment arms.
    - Functional outcome in patients with acute ischemic stroke: modified Rankin scale at 90 days, between two treatment arms.
    - Variations of serum glutamate curves in patients with acute ischemic stroke between two branches: all concentrations of serum glutamate.
    - Prognosis of patients without stroke: modified Rankin scale at 90 days.
    - Safety management: measuring adverse events throughout the study.
    - Estancia media en pacientes con ictus isquémico agudo: (en días) entre legada a urgencias y alta, entre ambas ramas de tratamiento.
    - Porcentaje de mejoría clínica (basal-alta) en pacientes con ictus isquémico agudo: mejoría clínica según la fórmula: (NIHSSbasal-NIHSSalta)/NIHSSbasal x 100.
    - Pronóstico funcional en pacientes con ictus isquémico agudo: escala de Rankin modificada a los 90±5 días.
    - Variaciones de las curvas séricas de glutamato en pacientes con ictus isquémico agudo: comparación de las concentraciones de glutamato sérico.
    - Pronóstico de los pacientes que no tienen infarto cerebral: escala de Rankin modificada a los 90±5 días.
    - Seguridad: medida de los acontecimientos adversos ocurridos a lo largo del estudio.
    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 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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
    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 months9
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients arriving at the emergency room with a low degree of consciousness
    Pacientes que llegan a urgencias con un bajo grado de conciencia
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    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 Decision2015-01-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-29
    P. End of Trial
    P.End of Trial StatusCompleted
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