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    Summary
    EudraCT Number:2012-002944-25
    Sponsor's Protocol Code Number:EuroHyp-1
    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:2014-07-22
    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 number2012-002944-25
    A.3Full title of the trial
    EuroHYP-1: European multicentre, randomised, phase III clinical trial of therapeutic hypothermia plus best medical treatment versus best medical treatment alone for acute ischaemic stroke
    EuroHYP-1: Europäische, multizentrische, randomisierte klinische Prüfung der Phase III von therapeutischer Hypothermie zusammen mit bestmöglicher medizinischer Behandlung versus bestmöglicher medizinischer Behandlung allein bei akutem ischämischem Schlaganfall
    EuroHYP-1: Estudio en Fase III, aleatorizado, abierto, para evaluar el beneficio del enfriamiento terapéutico en pacientes adultos con ictus isquémico.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EuroHYP-1: European phase III clinical trial at multiple trial sites and with random allocation of patients to treatment groups. The trial compares whole body cooling plus best medical treatment to best medical treatment alone in patients with acute stroke.
    EuroHYP-1: Europäische klinische Prüfung der Phase III in zahlreichen Prüfstellen und mit zufälliger Zuordnung der Patienten zu den Behandlungsgruppen. Die Studie vergleicht Ganzkörper-Kühlung plus bestmögliche medizinische Behandlung mit bestmöglicher medizinischer Behandlung allein bei Patienten mit akutem Schlaganfall.
    EuroHYP-1: Ensayo clínico Europeo en fase III multicéntrico y con asignación aleatoria de los pacientes a los grupos de tratamiento. El ensayo compara el enfriamiento terapéutico corporal, acompañado con el mejor tratamiento médico con respeto al mejor tratamiento médico sólo, en pacientes con ictus agudo.
    A.3.2Name or abbreviated title of the trial where available
    EuroHYP-1
    EuroHYP-1
    EuroHYP-1
    A.4.1Sponsor's protocol code numberEuroHyp-1
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01833312
    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 SponsorUniversitätsklinikum Erlangen
    B.1.3.4CountryGermany
    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 supportEuropean Commission
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNeurologische Klinik, Universitätsklinikum Erlangen
    B.5.2Functional name of contact pointDirektion
    B.5.3 Address:
    B.5.3.1Street AddressSchwabachanlage 6
    B.5.3.2Town/ cityErlangen
    B.5.3.3Post code91054
    B.5.3.4CountryGermany
    B.5.4Telephone number+4991318534563
    B.5.5Fax number+4991318536597
    B.5.6E-mailstefan.schwab@uk-erlangen.de
    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.2.1.2Country which granted the Marketing AuthorisationGermany
    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 INNPETHIDINE HYDROCHLORIDE
    D.3.9.1CAS number 50-13-5
    D.3.9.3Other descriptive namePETHIDINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB03726MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.2.1.2Country which granted the Marketing AuthorisationGermany
    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 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 INNBUSPIRONE HYDROCHLORIDE
    D.3.9.1CAS number 33386-08-2
    D.3.9.3Other descriptive nameBUSPIRONE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB00906MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    Acute ischaemic stroke
    Akuter ischämischer Schlaganfall
    Ictus isquémico agudo
    E.1.1.1Medical condition in easily understood language
    Acute stroke without bleeding in the brain
    Akuter Schlaganfall ohne Blutung im Gehirn
    Ictus agudo sin sangrado 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 10061256
    E.1.2Term Ischaemic stroke
    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
    To determine whether systemic cooling to a target body temperature between 34.0 and 35.0°C, started within 6 hours of symptom onset and maintained for 24 hours, improves functional outcome at 3 months in patients with acute ischaemic stroke.
    Es soll untersucht werden, ob systemische Kühlung auf eine Zielkörpertemperatur zwischen 34.0 und 35.0°C, die innerhalb von 6 Stunden nach Auftreten der Erstsymptome begonnen und über 24 Stunden aufrechterhalten wird, das funktionale Ergebnis nach 3 Monaten bei Patienten mit akutem ischämischem Schlaganfall verbessert.
    Determinar si el ?enfriamiento terapéutico? (hipotermia) con una temperatura objetivo de 34 a 35°C, iniciada dentro de las primeras 6 horas desde el comienzo de los síntomas y mantenida durante 24 horas mejora el pronóstico funcional a los 3 meses en pacientes con ictus isquémico agudo.
    E.2.2Secondary objectives of the trial
    ? To assess the effect of systemic cooling to a target body temperature between 34.0 and 35.0°C, started within 6 hours of symptom onset and maintained for 24 hours, in patients with acute ischaemic stroke on
    ? mortality at 3 months.
    ? neurological outcome at 3 months.
    ? quality of life at 3 months.
    ? cerebral infarct size at 48±24 hours.
    ? To determine the safety and tolerability of systemic cooling in patients with acute ischaemic stroke.
    ? Bewertung des Effekts von systemischer Kühlung auf eine Zielkörpertemperatur zwischen 34.0 und 35.0°C, die innerhalb von 6 Stunden nach Auftreten der Erstsymptome begonnen und über 24 Stunden aufrechterhalten wird, bei Patienten mit akutem ischämischem Schlaganfall auf
    ? die Sterblichkeit nach 3 Monaten.
    ? das neurologische Ergebnis nach 3 Monaten.
    ? die Lebensqualität nach 3 Monaten.
    ? die Größe des Hirninfarkts nach 48±24 Stunden.
    ? Überprüfung der Sicherheit und Verträglichkeit von systemischer Kühlung bei Patienten mit akutem ischämischem Schlaganfall.
    Evaluar la eficacia de la hipotermia con una temperatura objetivo de 34 a 35°C, iniciada dentro de las primeras 6 horas desde el comienzo de los síntomas y mantenida durante 24 horas en pacientes con ictus isquémico agudo en cuanto a:
    o mortalidad a los 3 meses.
    o Pronóstico funcional a los 3 meses.
    o Calidad de vida a los 3 meses.
    o Tamaño del infarto cerebral a las 48±24 horas.

    Determinar la seguridad y tolerabilidad de la hipotermia en pacientes con ictus isquémico agudo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The trial population consists of patients of both sexes, aged ?18 years, with acute ischaemic stroke and a score on the NIHSS of 6 up to and including 18 at screening [Assessment 1, within 90 minutes before the start of the treatment phase TP].
    ? Written informed consent obtained from the patient or his/her legally acceptable representative or under such other arrangements as may be legally established in participating countries.
    ? Estimated body weight of 50kg up to and including 120kg.
    ? Possibility to start therapeutic hypothermia within 6 hours after onset of stroke.
    ? Possibility to start therapeutic hypothermia within 90 minutes after start of alteplase administration in patients receiving thrombolysis.
    ? Possibility to start therapeutic hypothermia within 90 minutes after admission to trial site in patients not receiving thrombolysis.
    ? mRS score ?2 prior to onset of stroke.
    ? GCS motor response subscale score ?5.
    Die Studienpopulation besteht aus Patienten beiderlei Geschlechts im Alter von ?18 Jahren mit akutem ischämischem Schlaganfall und einem Wert auf der NIHSS von 6 bis einschließlich 18 zum Zeitpunkt des Screenings [Assessment 1, innerhalb von 90 Minuten vor dem Start der Behandlungsphase TP].
    ? Schriftliche Erklärung des Einverständnisses mit der Teilnahme an der klinischen Prüfung durch den Patienten oder seinem gesetzlichen Vertreter oder nach einem anderen vom Gesetzgeber des jeweiligen teilnehmenden Landes vorgesehenen Verfahren.
    ? Geschätztes Körpergewicht von 50kg bis zu 120kg einschließlich.
    ? Möglichkeit gegeben, dass die therapeutische Hypothermie innerhalb von 6 Stunden nach Auftreten der ersten Schlaganfallsymptome begonnen werden kann.
    ? Möglichkeit gegeben, dass die therapeutische Hypothermie innerhalb von 90 Minuten nach Start der Gabe von Alteplase bei Patienten begonnen werden kann, die eine Lysetherapie erhalten.
    ? Möglichkeit gegeben, dass die therapeutische Hypothermie innerhalb von 90 Minuten nach Aufnahme in die Prüfstelle bei Patienten begonnen werden kann, die keine Lysetherapie erhalten.
    ? mRS-Wert ?2 vor Auftreten der ersten Schlaganfallsymptome.
    ? GCS motor response subscale-Wert ?5.
    La población del estudio consiste en: pacientes de ambos sexos, con edad ?18 años, con ictus isquémico agudo y una puntuación en la escala NIHSS (National Institutes of Health Stroke Scale) de 6 hasta 18 puntos inclusive, en el momento de la selección [Evaluación 1, dentro de los primeros 90 minutos antes del inicio de la fase de tratamiento (FT)].
    1. Consentimiento informado por escrito.
    2. Peso estimado de 50 a 120 kg (ambos inclusive).
    3. Posibilidad de iniciar hipotermia terapéutica dentro de las primeras 6 horas desde el inicio del ictus.
    4. Posibilidad de iniciar hipotermia terapéutica dentro de los primeros 90 minutos desde la administración de alteplasa (en los pacientes que recibieron trombólisis), o dentro de los primeros 90 minutos después del ingreso en pacientes que no han recibido trombólisis.
    5. Puntuación en la escala de Rankin modificada ?2 previa al ictus.
    6. Puntuación ?5 en la subescala motora de la Escala del Coma de Glasgow.
    E.4Principal exclusion criteria
    1. Use of monoaminoxidase inhibitors in the 14 days prior to screening.
    2. Current use of medication interacting with pethidine or buspirone.
    3. Acute alcohol intoxication.
    4. Opioid addiction.
    5. Nursing mother or pregnant woman, as verified by a positive urine pregnancy test in females of childbearing potential.
    6. Known hypersensitivity to the IMPs or any of their formulation ingredients.
    7. Patient who is imprisoned or is lawfully kept in an institution.
    8. Employee or direct relative of an employee of the CRO (if applicable), the department of the investigator, or the sponsor.
    9. Participation in an interventional clinical trial within the last 4 weeks, or be under the exclusion period from another trial.
    10. Prior participation in this trial.
    11. Any acutely life-threatening conditions other than acute ischaemic stroke.
    12. Rapidly resolving stroke symptoms.
    13. Evidence from CT or MRI of intracranial haemorrhage or tumour or encephalitis or any diagnosis likely to cause the present symptoms other than acute ischaemic stroke.
    14. Known convulsive disorder, acute closed angle glaucoma, myasthenia gravis.
    15. SPO2 <94% (as measured by pulse oximetry) under nasal oxygen administration.
    16. Other severe respiratory disorder.
    17. Bradycardia (<40 bpm).
    18. Severe cardiac failure, defined as NYHA classification ?III.
    19. Myocardial infarction or angina pectoris in the 3 months prior to screening.
    20. Vasospastic disorders.
    21. Haematological dyscrasia (e.g., sickle cell disease, cryoglobulinaemia).
    22. Known platelet count <100,000/mm3.
    23. Known INR >1.7.
    24. Skin damage at the sites intended to be used for cooling.
    25. Clinical diagnosis of sepsis.
    26. Known severe hepatic impairment (serum ALAT and/or ASAT >3 times ULN).
    27. Known renal impairment (serum creatinine >2mg/100ml).
    28. Addison?s disease.
    29. Any other condition that may interfere with, or be aggravated by, therapeutic hypothermia.
    30. Any condition that is thought to reduce the compliance to cooperate with the trial procedures .
    1. Einnahme von Monoaminoxydasehemmern in den 14 Tagen vor Screening.
    2. Derzeitige Einnahme von Arzneimitteln, die mit Pethidin oder Buspiron interagieren.
    3. Akute Alkoholintoxikation.
    4. Opiatabhängigkeit.
    5. Stillende oder Schwangere (positiver Urintest bei Frauen im gebärfähigen Alter).
    6. Bekannte Überempfindlichkeit gegenüber den Prüfpräparaten oder den Hilfsstoffen.
    7. Patient, der auf gerichtliche oder behördliche Anweisung in einer Anstalt untergebracht ist.
    8. Angestellter oder direkter Verwandter eines Angestellten der CRO (falls zutreffend), der Abteilung des Prüfers oder des Sponsors.
    9. Teilnahme an einer interventionellen klinischen Studie in den letzten 4 Wochen oder in der Ausschlussfrist von einer anderen Studie.
    10. Frühere Teilnahme an dieser klinischen Prüfung.
    11. Alle akut lebensbedrohlichen Zustände außer akutem ischämischem Schlaganfall.
    12. Rasch rückläufige Schlaganfallsymptome.
    13. Nachweis im CT oder MRT einer intrakraniellen Blutung oder eines Tumors oder einer Enzephalitis oder jeder anderen Diagnose außer akutem ischämischem Schlaganfall, die die vorhandenen Symptome hervorrufen kann.
    14. Bekanntes Anfallsleiden, akutes Engwinkelglaukom, Myasthenia gravis.
    15. Periphere Sauerstoffsättigung <94% (gemessen mittels Pulsoxymetrie) unter nasaler Sauerstoffzufuhr.
    16. Andere schwerwiegende respiratorische Störungen.
    17. Bardykardie (<40 Schläge/min).
    18. Schwere Herzinsuffizienz (NYHA ?III).
    19. Myokardinfarkt oder Angina pectoris in den letzten 3 Monaten.
    20. Vasospastische Störungen.
    21. Hämatologische Störungen (z.B. Sichelzellanämie, Kryoglobulinämie).
    22. Bekannte Thrombozytenzahl <100.000/mm³.
    23. Bekannte INR>1,7.
    24. Hautschäden an Stellen, die für die Kühlung vorgesehen sind.
    25. Klinische Sepsisdiagnose.
    26. Bekannte schwere Leberfunktionsstörung (Serum-GPT/-GOT >3facher oberer Grenzwert).
    27. Bekannte Nierenfunktionsstörung (Serumkreatinin >2mg/100ml).
    28. M. Addison.
    29. Alle anderen Zustände, die mit therapeutischer Hypothermie interferieren oder durch diese verschlechtert werden können.
    30. Alle Zustände, die die Mitarbeit des Patienten beeinträchtigen können.
    1. Uso de inhibidores de la monoaminoxidasa dentro de los 14 dias previos
    2. Uso actual de medicamentos que interactúan con petidina o buspirona. Ej. ritonavir, fenitoína, cimetidina, fenotiazinas, opioides y agonistas parciales de los opioides (ej. pentazocina, nalbufina, buprenorfina).
    3. Intoxicación aguda alcohólica.
    4. Adicción a opioides.
    5. Mujer en período de lactancia o embarazo, confirmado con un test de embarazo positivo en orina, en mujeres en edad fértil.
    6. Hipersensibilidad conocida a los fármacos del estudio (Petidina, Buspirona, Ondansetrón, Granisetrón) o alguno de los componentes de su formulación.
    7. Paciente que está prisionero o mantenido en una institución por mandato legal.
    8. Empleado o familiar directo de un empleado de la CRO (si es aplicable), del departamento del investigador o del sponsor
    9. Participación en otro ensayo clínico intervencionista dentro de las últimas 4 semanas, o estar en el periodo de exclusión de otro ensayo.
    10. Participación previa en este ensayo.
    11. Cualquier condición aguda potencialmente fatal distinta al ictus isquémico.
    12. Síntomas del ictus rápidamente regresivos.
    13. Evidencia en la TC o RM de hemorragia intracraneal, tumor, encefalitis o cualquier diagnóstico que pueda causar los síntomas actuales, distinta del ictus isquémico.
    La transformación hemorrágica no es un criterio de exclusión, excepto cuando hay un hematoma parenquimatoso que abarca más del 30% del área infartada, con efecto de masa significativo, o cuando existe una hemorragia alejada del infarto.
    14. Antecedente conocido de trastorno convulsivo, glaucoma de ángulo agudo, miastenia gravis.
    15. Saturación de oxígeno por debajo del 94% (SPO2 <94%) en pacientes con administración de oxígeno nasal.
    16. Otra enfermedad respiratoria severa.
    17. Bradicardia (<40 lpm).
    18. Insuficiencia cardiaca severa, definida como clasificación NYHA ?III.
    19. Infarto agudo al miocardio o angina de pecho en los 3 meses previos.
    20. Trastorno vasoespástico (Ej., Enfermedad de Raynaud).
    21. Discrasia sanguínea (Ej: anemia de células falciformes, crioglobulinemia).
    22. Recuento plaquetario <100,000/mm3.
    23. INR >1.7
    24. Lesiones cutáneas (Ej. inflamación, quemaduras, úlceras,
    hives, rash) en lugares donde se aplicaría la hipotermia
    25. Diagnóstico clínico de sepsis.
    26. Daño hepático severo conocido (ALAT y/o ASAT >3 veces por encima del límite superior de normalidad).
    27. Daño renal conocido (creatinina sérica >2mg/100ml).
    28. Enfermedad de Addison.
    29. Alguna otra condición que pueda interferir o ser agravada por la hipotermia.
    30. Cualquier condición que se sospeche que reducirá la adherencia o cooperación con los procedimientos del ensayo.
    E.5 End points
    E.5.1Primary end point(s)
    Score on the mRS.
    Wert auf der mRS.
    Puntuación de la mRS
    E.5.1.1Timepoint(s) of evaluation of this end point
    At outcome assessment [A7, Day 91±14 days].
    Zum Zeitpunkt der Ergebnisbewertung [A7, Tag 91±14 Tage].
    En la evaluación final del estudio [A7, Día 91±14 días]
    E.5.2Secondary end point(s)
    ? Death or dependency, defined as a score on the mRS >2.
    ? Death.
    ? Score on NIHSS.
    ? Brain infarct size.
    ? WHODAS 2.0 score.
    ? EQ-5D-5L score.
    ? Tod oder Abhängigkeit, definiert als ein Wert auf der mRS >2.
    ? Tod.
    ? Wert auf der NIHSS.
    ? Größe des Hirninfarkts.
    ? WHODAS 2.0-Wert.
    ? EQ-5D-5L-Wert.
    ? Muerte o dependencia, definidas como un puntuación en la mRS >2
    ? Muerte
    ? Puntuación en la escala NIHSS
    ? Tamaño del infarto cerebral
    ? Puntuación WHODAS 2.0
    ? Puntuación EQ-5D-5L
    E.5.2.1Timepoint(s) of evaluation of this end point
    ? Death or dependency, defined as a score on the mRS >2 at outcome assessment [A7, Day 91±14 days].
    ? Death at outcome assessment [A7, Day 91±14 days].
    ? Score on NIHSS at outcome assessment [A7, Day 91±14 days].
    ? Brain infarct size at imaging assessment [A4, Hour 48±24 hours].
    ? WHODAS 2.0 score at outcome assessment [A7, Day 91±14 days].
    ? EQ-5D-5L score at outcome assessment [A7, Day 91±14 days].
    ? Tod oder Abhängigkeit, definiert als ein Wert auf der mRS >2 zum Zeitpunkt der Ergebnisbewertung [A7, Tag 91±14 Tage].
    ? Tod zum Zeitpunkt der Bewertung des funktionalen Ergebnisses [A7, Tag 91±14 Tage].
    ? Wert auf der NIHSS zum Zeitpunkt der Bewertung des funktionalen Ergebnisses [A7, Tag 91±14 Tage].
    ? Größe des Hirninfarkts zum Zeitpunkt der Bewertung der Bildgebung [A4, Stunde 48±24 Stunden].
    ? WHODAS 2.0-Wert zum Zeitpunkt der Bewertung des funktionalen Ergebnisses [A7, Tag 91±14 Tage].
    ? EQ-5D-5L-Wert zum Zeitpunkt der Bewertung des funktionalen Ergebnisses [A7, Tag 91±14 Tage].
    ? Muerte o dependencia, definidas como un puntuación en la mRS >2 en la visita final [A7, día 91±14 días].
    ? Muerte en la evaluación de la visita final [A7, día 91±14 días].
    ? Puntuación en la escala NIHSS en la visita final [A7, día 91±14 días].
    ? Tamaño del infarto cerebral en la evaluación de imágenes [A4, hora 48±24 horas].
    ? Puntuación WHODAS 2.0 en la evaluación de la visita final [A7, día 91±14 días].
    ? Puntuación EQ-5D-5L en la evaluación de desenlace [A7, día 91±14 días].
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Bestmögliche medizinische Behandlung.
    Mejor tratamiento médico
    Best medical treatment.
    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 concerned18
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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 Yes
    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.
    Letzte Visite des letzten Studienteilnehmers.
    Última visita del último paciente
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months9
    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 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: 750
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 750
    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 Yes
    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
    Given the very nature of acute ischaemic stroke, obtaining valid informed consent from the patient may not always be possible. In such cases, informed consent will be sought in compliance with national rules and regulations.
    Bei akutem ischämischem Schlaganfall ist es nicht immer möglich, eine Zustimmung des Patienten zu seiner Teilnahme an der klinischen Prüfung zu erlangen. In solchen Fällen wird die Zustimmung unter Einhaltung der nationalen Vorschriften eingeholt.
    Dada las características clínicas del ictus isquémico agudo, no siempre será posible obtener el consentimiento del paciente directamente. En estos casos, el consentimiento se obtendrá según la legislación nacional vigente.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state230
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1500
    F.4.2.2In the whole clinical trial 1500
    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)
    Standard therapy.
    Standardtherapie.
    Terapia Estándar
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation EuroHYP - European Stroke Research Network for Hypothermia
    G.4.3.4Network Country Belgium
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-08-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-06-14
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