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    Summary
    EudraCT Number:2012-000184-24
    Sponsor's Protocol Code Number:EC11-222
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2014-04-01
    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 number2012-000184-24
    A.3Full title of the trial
    Whole body hypothermia + melatonin vs whole body hypothermia + placebo in asphyctic newborns. A multicentric, ramdomized, controlled and double blind clinical trial
    ESTUDIO MULTICENTRICO ALEATORIZADO, CONTROLADO Y DOBLE CIEGO CON HIPOTERMIA CORPORAL TOTAL + MELATONINA VS. HIPOTERMIA CORPORAL TOTAL + PLACEBO EN RECIÉN NACIDOS CON ASFIXIA NEONATAL.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Whole body hypothermia + melatonin vs whole body hypothermia + placebo in asphyctic newborns. A multicentric, ramdomized, controlled and double blind clinical trial
    Ensayo clinico en recién nacidos con asfixia perinatal enfriados + melatonina vs enfriados+ placebo

    Newborns with perinatal asphyxia treated with cooling therapy + melatonin vs cooling therapy + placebo. A clinical trial
    A.3.2Name or abbreviated title of the trial where available
    hypothermia + melatonin in asphyctic newborns
    A.4.1Sponsor's protocol code numberEC11-222
    A.5.4Other Identifiers
    Name:EC11-222Number:A Jerez
    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 SponsorANTONIO JEREZ CALERO
    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 supportMINISTERIO DE SANIDAD Y CONSUMO
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFIBAO
    B.5.2Functional name of contact pointJACQUELINE GUALDA RIVAS
    B.5.3 Address:
    B.5.3.1Street AddressAV. DR OLORIZ, 16
    B.5.3.2Town/ cityGRANADA
    B.5.3.3Post code18012
    B.5.3.4CountrySpain
    B.5.4Telephone number34958023568
    B.5.5Fax number34958023568
    B.5.6E-mailjacqueline.gualda.exts@juntadeandalucia.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 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 nameMELATONINA IV
    D.3.2Product code MELATONINA IV
    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 INNMelatonin
    D.3.9.1CAS number 73-31-4
    D.3.9.2Current sponsor codePNF-MEL-6-01
    D.3.9.3Other descriptive nameMELATONIN
    D.3.9.4EV Substance CodeSUB14496MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.5
    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
    Hipothermia plus melatonine neuroprotection terapy in asphixiated newborns.
    Neuroprotección inducida por terapia con hipotermia y melatonina en pacientes con asfixia perinatal
    E.1.1.1Medical condition in easily understood language
    Improvement on neurodevelopment aspects in newborns treated with Melatonin and whole body cooling therapy
    Mejoría en desarrollo neurológico en pacientes recién nacidos tratados con melatonina más enfriamiento corpotal .
    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
    In asphyctic and cooled newborn we expect that Melatonin administration will decrease neurolesive free radicals production and wil prevent neurological damage derivated of their antiiflamatories and oxidative effects.
    La administración de melatonina a los recien nacidos asfícticos enfriamos pretende disminuir la producción de radicales libres neurolesivos y secundariamente evitar el daño neurológico derivado de sus efectos inflamatorios y oxidativos.
    E.2.2Secondary objectives of the trial
    Other consequences:
    - measure of proinflamatory biomarkers derivated of oxidative stress and neuronal damage
    - Neurodevelopment assessment at 6 and 18 months specific tests
    - Magnetic Resonance Cerebral Images abnormalities
    - Electroencephalografic patterns in Cerebral Function Monitor
    - Visual and brain stem evoked potentials
    Monitoring security settings:
    - Hematologic: anemia, thrombocytopenia, leukopenia or neutropenia, coagulopathy
    - Digestive: days of parenteral nutrition, cholestasis, significant elevation of transaminases,NEC or days to full enteral nutrition.
    - Infectious : sepsis. Alteration of analytical infectious markers
    - Neurological : intraventricular hemorrhage , white matter injury, clinical/EEG seizures
    - Renal: Oligoanuria, glycosuria , proteinuria; serum urea and creatinine , hypertension
    - Respiratory: days of mechanical ventilation/oxigen, need for NO, pneumothorax
    - Skin: subcutaneous fat necrosis, dermatitis or other notable changes .
    Otras consecuencias.
    - medida de biomarcadores inflamatorios derivados del stress oxidativo y daño neuronal
    - Valoración de neurodesarrollo mediante tests especificos a los 6 y 18 meses
    - Anomalías en Resonancia Magnética Cerebral
    - Patrones electroencefalográficos en el monitor de función cerebral
    - Potenciales evocados visuales y de tronco-encéfalo

    Monitorización de parámetros de seguridad:
    - Hematológico: anemia, trombopenia, leuco/neutropenia, coagulopatia
    - Digestivo: días de nutrición parenteral, colestasis , elevación transaminasas, NEC,días hasta nutrición enteral completa.
    - Infecciosos: sepsis. Alteración de marcadores infecciosos analíticos
    - Neurológicos: Hemorragia intraventricular,lesión en sustancia blanca, convulsiones clinicas/electricas
    - Renal: Oligoanuria,glucosuria, proteinuria,Urea y Creatinina séricas, hipertensión arterial
    - Respiratorio: dias de ventilación mecánica/O2, neumotórax
    - Piel: necrosis grasa subcutanea, dermatitis u otras.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with A and B criteria.
    (and whose parents legal guardian has accepted and signed the informed consent document)
    A. Newborns, Gestational age >36 weeks, within 6 hours of birth and at least ONE of the followings:
    - Apgar test <5 at 5 minutes from birth
    - Need for resuscitation longer than 10 minutes using Positive Presion ventilacion (bag and mask or endotraqueal tube)
    - ph <7 or BD<16 mmol/L in the worse gasometric result at first 60 minutes from birth (cord, arterial, venose or capilar blood sample)
    and
    B. Moderate and severe Hipoxic-ischemic encephalopaty.
    - Sarnat score >6 points
    Pacientes que incluyan criterios de A+B
    (y cuyos padres o tutores legales hayan aceptado y firmado el documento de consentimiento informado)
    A. Recien nacidos de >36 semanas de gestación, de menos de 6 horas de vida, con al menos UNO de los siguientes criterios:
    - Test de Apgar < 5 a los 5 minutos del nacimiento
    - Necesidad de reanimación en sala de partos durante más de 10 minutos mediante ventilación con presión positiva (bolsa y mascarilla o tubo endotraqueal)
    - pH<7 ó EB<16 mmol/L en la peor gasometría de los primeros 60 minutos de vida (sangre de cordón,arterial, venosa o capilar)
    y
    B. Criterios de encefalopatía clínica moderada o grave:
    - Score de Sarnat >6 puntos
    E.4Principal exclusion criteria
    - Birth weight <1800 g
    - Gestacional age < 36 weeks
    - Newborn with over 6 hours of life
    - Need for surgery during first 3 days of life
    - Severe congenital malformations
    - Severe multiorganic disfunction and refractaria treatment
    - Peso al nacer <1800 g
    - Edad gestacional < 36 semanas
    - Recien nacido con más de 6 horas de vida
    - Patología que requiera cirugía en los tres primeros días de vida
    - Malformaciones congénitas graves
    - Disfunción multiorgánica grave y refractaria al tratamiento
    E.5 End points
    E.5.1Primary end point(s)
    Better scores on Neurodevelopment test in cooled newborns treated with melatonin vs placebo
    Mejores puntuaciones en escala de neurodesarrollo en recien nacidos enfriados tratados con melatonina vs tratados con placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 and 18 months of life
    6 y 18 meses de vida
    E.5.2Secondary end point(s)
    -lower plasmatic concentrations of proinflamatory biomarkers derivated of oxidative stress and neuronal damage (end point n. 2)
    - Type and of brain damaged areas obtained by Magnetic Resonance Imaging (end point n. 3)
    - poor prognosis electroencephalografic patterns at Function Cerebral Monitor (end point n. 4)
    - Menores concentraciones plasmáticas de biomarcadores inflamatorios derivados de estres oxidativo y daño neuronal (objetivo final nº 2)
    - Tipo y extensión del daño cerebral obtenido por Resonancia Magnética Nuclear (objetivo final nº 3)
    - Patrones electroencefalográficos de mal pronóstico en Monitor de Funcion Cerebral (objetivo final nº 4)
    E.5.2.1Timepoint(s) of evaluation of this end point
    - End point n. 2: 3-6 hours, 24 h, 72 h and 7-10 days of life
    - End point n. 3: newborn period and 12 months of life
    - End point n. 4: during first 72 hours of life (at least)
    - objetivo final nº 2: 3-6 horas, 24 h, 72 h and 7-10 dias de vida
    - objetivo final nº 3: Periodo neonatal y 12 meses de vida
    - objetivo final nº 4:durante las primeras 72 horas de vida (al menos)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 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 No
    E.8.1.4Double blind Yes
    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 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 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 concerned2
    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 Yes
    F.1.1Number of subjects for this age range: 36
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 36
    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) No
    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 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 newborns
    pacientes neonatos
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state36
    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
    No
    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 Decision2014-09-19
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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    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
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