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 are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   35554   clinical trials with a EudraCT protocol, of which   5841   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).
     
    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:2012-002944-25
    Sponsor's Protocol Code Number:4.0
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-03-10
    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 ConcernedIreland - HPRA
    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.
    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.
    A.4.1Sponsor's protocol code number4.0
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN42686094
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01833312
    A.5.3WHO Universal Trial Reference Number (UTRN)U0000-0000-0000
    A.5.4Other Identifiers
    Name:EuroHYP-1Number:EuroHYP-1
    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 SponsorSt James's Hospital, Dublin
    B.1.3.4CountryIreland
    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 Union FP-7
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Edinburgh, Division of Clinical Neurosciences
    B.5.2Functional name of contact pointEuroHYP-1 Associate Trial Manager.
    B.5.3 Address:
    B.5.3.1Street AddressBramwell Dott Building, Crewe Road South
    B.5.3.2Town/ cityEdinburgh
    B.5.3.3Post codeEH4 2XU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number44131537 2930
    B.5.5Fax number44131537 2930
    B.5.6E-mailBridget.Colam@ed.ac.uk
    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 Buspirone
    D.2.1.1.2Name of the Marketing Authorisation holderActavis UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameBuspirone Hydrochloride
    D.3.2Product code SUB00906MIG
    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.3.9.2Current sponsor codeBuspirone Hydrochloride
    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 typerange
    D.3.10.3Concentration number5 to 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Pethidine Hydrochloride
    D.2.1.1.2Name of the Marketing Authorisation holderMercury Pharmaceuticals (Ireland)Ltd
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 namePethidine Hydrochloride
    D.3.2Product code PA0073/014/001
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codePethidine Hydrochloride
    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 to 50
    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
    E.1.1.1Medical condition in easily understood language
    Acute stroke without bleeding in the brain.
    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 19.0
    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 12 hours, improves functional outcome at 3 months in patients with acute ischaemic stroke.
    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 12 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.
    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 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 150 minutes after start of alteplase administration in patients receiving thrombolysis at the trial site or within 150 minutes after start of endovascular treatment, if this is later.
    - Possibility to start therapeutic hypothermia within 90 minutes after admission to trial site in patients not receiving thrombolysis or in patients who have received thrombolysis at a different site.
    - mRS score ≤2 prior to onset of stroke.
    - GCS motor response subscale score ≥5.
    E.4Principal exclusion criteria
    1.Current use of medication interacting with pethidine or buspirone.
    2. Use of monoaminoxidase inhibitors in the 14 days prior to screening. 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 .
    E.5 End points
    E.5.1Primary end point(s)
    Handicap score on the Modified Rankin Scale
    E.5.1.1Timepoint(s) of evaluation of this end point
    At outcome assessment [A7, Day 91±14 days].
    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.
    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].
    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 Yes
    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
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    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 months0
    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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 550
    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
    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 and ethical approval.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 800
    F.4.2.2In the whole clinical trial 800
    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 for stroke.
    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 Decision2016-05-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-05-09
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA