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   43871   clinical trials with a EudraCT protocol, of which   7290   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:2010-023048-34
    Sponsor's Protocol Code Number:NT-KO-003-2010-01
    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:2011-01-20
    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 number2010-023048-34
    A.3Full title of the trial
    Ensayo Clínico Fase IIa, Multicéntrico, Doble Ciego para Evaluar la Eficacia y Seguridad de dosis bajas de Diazoxida oral en el tratamiento de la Esclerosis Múltiple
    A.4.1Sponsor's protocol code numberNT-KO-003-2010-01
    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 SponsorNEUROTEC PHARMA, S.L
    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 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 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 nameDiazoxida
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNDiazoxida
    D.3.9.1CAS number 364-98-7
    D.3.9.2Current sponsor codeNT-KO-003
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 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 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.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 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 nameDiazoxida
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNDiazoxida
    D.3.9.1CAS number 364-98-7
    D.3.9.2Current sponsor codeNT-KO-003
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.3
    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 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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Tratamiento de la Esclerosis Múltiple.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13
    E.1.2Level LLT
    E.1.2Classification code 10063399
    E.1.2Term Esclerosis múltiple remitente-recurrente
    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 eficacia de Diazoxida en pacientes con EMRR, medida como el número acumulado de lesiones nuevas observadas en todas las RM, a excepción de la del periodo basal.
    E.2.2Secondary objectives of the trial
    Evaluar la eficacia de Diazoxida en pacientes con EMRR (lesiones que se realzan con gadolinio y lesiones T2) en todas las RM.
    Evaluar la eficacia clínica de Diazoxida en pacientes con EMRR, medida como cambios en la tasa de recidivas y escala EDSS.
    Evaluar la seguridad del tratamiento de Diazoxida en pacientes con EMRR, medida como la incidencia de acontecimientos adversos.
    Otros objetivos:
    Se evaluarán:
    1a. Marcadores de la respuesta funcional (macrófagos): se usarán ensayos con macrófagos en los estudios funcionales ex vivo (producción de TNF-alfa e IL-1beta tras la estimulación con lipopolisacárido en células pretratadas con diazoxida) que clasificará a los pacientes en función de su buena o mala respuesta al tratamiento.

    1b. Niveles de fármaco y de citocromo P450: En las visitas 3 y 6 se evaluarán los niveles de fármaco y en las visitas 0, 3 y 6 se evaluaran los niveles de las del citocromo P450.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Sub-estudio genético (Biomarcadores), V1.0 22 nov. 2010. - Evaluar los biomarcadores eficacia del tratamiento en pacientes con EMRR: RNA (analizar la expresión de los genes implicados en progresión enfermedad y actividad fármaco); DNA (identificar polimorfismos asociados al metabolismo y actividad de diazoxida, se genotipificarán genes relacionados mecanismo de acción o metabolismo fármaco). - Para evaluar los marcadores de neuroprotección subestudio tomografía de coherencia óptica (TCO).
    E.3Principal inclusion criteria
    1. Pacientes que cumplen los criterios diagnósticos de EM conforme a las directrices proporcionadas por McDonald y cols. (1)
    2. Pacientes que cumplen los criterios diagnósticos de CIS (con criterios de diseminación en el tiempo y el espacio) o EMRR.
    Nota: CIS con diseminación en el tiempo y el espacio se puede considerar EMRR utilizando los nuevos criterios (1), pero mantenemos el término CIS para el aspecto clínico de reclutar pacientes con solo 1 recidiva.
    3. Pacientes con incapacidad clínica medida por una puntuación EDSS entre 0 y 5,0, ambas cifras incluidas.
    4. Los pacientes que presentan al menos 1 recidiva en los 2 años anteriores o presencia de al menos 1 lesión realzada con gadolinio en el año anterior.
    5. Pacientes de edades comprendidas entre los 18 y los 55 años, de ambos sexos.
    E.4Principal exclusion criteria
    1. Pacientes con recidiva en el periodo de 30 días antes de la visita basal.
    2. Pacientes en tratamiento con diazoxida.
    3. Afecciones médicas como hipotensión, insulinoma, hiperuricemia.
    4. Pacientes diabéticos de acuerdo a la definición ADA (2).
    5. Otras afecciones: toxicomanía, incapacidad para otorgar el consentimiento o incapacidad para efectuar todos los procedimientos del ensayo clínico.
    6. Contraindicaciones para los estudios de RM: claustrofobia, marcapasos o cualquier otra condición que pudiera desaconsejar la proximidad a un campo magnético intenso.
    7. Contraindicaciones para el tratamiento con Diazoxida o excipientes. Alergias, hipersensibilidad.
    8. Pacientes con alergia conocida o contraindicaciones a la administración intravenosa de agentes de gadolinio (insuficiencia renal crónica o aguda según The Renal Association or NICE guidelines (3)).
    9. Tratamiento con corticoesteroides en el último mes.
    10. Tratamiento con Interferón-beta o acetato de glatirámero en los últimos 3 meses.
    11. Tratamiento con Natalizumab en los últimos 6 meses.
    12. Pacientes tratados con quimioterapia (mitroxantona) o que han participado en estudios anteriormente con tratamientos en desarrollo (ex. fingolimod).
    13. Pacientes participantes en otro ensayo clínico.
    14. Paciente que haya recibido un trasplante hepático o que sea candidato a un trasplante hepático.
    15. Prueba del embarazo positiva, mujeres en periodo de lactancia o en edad fértil que no usan métodos anticonceptivos altamente efectivos.
    16. Varones que no utilicen métodos anticonceptivos adecuados.
    E.5 End points
    E.5.1Primary end point(s)
    Principal:
    1. Eficacia (por Resonancia Magnética, RM), RM con dosis de contraste (compuesto de gadolinio a una dosis de 0,2 mmol/kg, utilizando el mismo compuesto de contraste para todos los pacientes del mismo centro, tiempo entre dosis de 10 minutos):
    Número acumulado de lesiones nuevas que se realzan con gadolinio en secuencias ponderadas en T1 (específicamente la adición de lesiones nuevas observadas en todas las RM, excepto la RM basal).
    Secundarias:
    1. Eficacia (por RM)
    Número acumulado de lesiones nuevas/ agrandadas en secuencias ponderadas en T2 en todas las RM.
    Número acumulado de lesiones nuevas/ agrandadas en las secuencias ponderadas en T2 en el sexto mes después del inicio del tratamiento (en comparación con la RM basal).
    Número acumulado de CUAL: adición de lesiones nuevas o agrandadas en secuencias ponderadas en T2 que no se realzan con gadolinio y nuevas lesiones que se realzan con gadolinio en todas las RM.
    Número acumulado de CUAL: adición de lesiones nuevas o agrandadas en secuencias ponderadas en T2 que no se realzan con gadolinio y lesiones nuevas que se realzan con gadolinio en el sexto mes después de iniciar el tratamiento (comparado con la RM basal).
    Número de pacientes sin lesiones en secuencias ponderadas en T1 realzadas con gadolinio en el sexto mes después de iniciar el tratamiento
    2. Eficacia (por evaluación clínica) en el sexto mes después de iniciar el tratamiento:
    Estado libre de recidivas.
    Tasa de recidivas.
    Número de recidivas que precisan tratamiento con corticoesteroides.
    Tiempo hasta la primera recidiva (durante el estudio).
    Cambios en la escala EDSS.
    Calidad de vida utilizando el cuestionario SF-36 (Short form 36 Healthy Survey Questionnaire)
    3. Seguridad (Incidencia, naturaleza y gravedad de los acontecimientos adversos): durante los 6 meses de duración del tratamiento y hasta 15 días después de la última dosis de Diazoxida o placebo.
    Presencia de acontecimientos adversos: control de las concentraciones de glucosa, hemoglobina glicosilada, tensión arterial, presencia de hirsutismo.
    Presencia de acontecimientos adversos graves.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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) 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.8.3 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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    El ensayo finalizará cuando los 105 pacientes de la muestra hayan realizado los 6 meses de tratamiento y la Visita 7 a los 15 días de la última dósis del tratamiento.
    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 days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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) No
    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 state81
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 105
    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 Decision2011-04-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-14
    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-Mon May 06 12:28:17 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA