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    Summary
    EudraCT Number:2013-001558-87
    Sponsor's Protocol Code Number:UBS-HG
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-12-30
    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 ConcernedSweden - MPA
    A.2EudraCT number2013-001558-87
    A.3Full title of the trial
    Safety of normalising slightly elevated plasma glucose by Exenatide in acute ischemic stroke patients treated with intravenous thrombolysis: a pilot study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety of normalising slightly elevated plasma glucose by Exenatide in acute ischemic stroke patients treated with intravenous thrombolysis: a pilot study
    A.4.1Sponsor's protocol code numberUBS-HG
    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 SponsorKarolinska University Hospital
    B.1.3.4CountrySweden
    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 supportKarolinska University Hospital
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKarolinska University Hospital
    B.5.2Functional name of contact pointKarolinska University Hospital
    B.5.3 Address:
    B.5.3.1Street AddressKarolinska University Hospital
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post code171 76
    B.5.3.4CountrySweden
    B.5.4Telephone number+46 8517 700 00
    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 BYETTA
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEXENATIDE
    D.3.9.1CAS number 141758-74-9
    D.3.9.4EV Substance CodeSUB21818
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Patients with acute ischemic stroke, treated with intravenous thrombolysis treatment according to the European regulatory criteria
    E.1.1.1Medical condition in easily understood language
    Patients with acute ischemic stroke, treated with intravenous thrombolysis treatment according to the European regulatory criteria
    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
    • To determine the safety of normalising of slightly elevated plasma glucose by exenatide (Byetta) in acute ischaemic stroke patients treated with intravenous rt-PA therapy
    • To investigate whether it is feasible to normalise of slightly elevated plasma glucose by exenatide (Byetta) in acute ischaemic stroke patients treated with intravenous rt-PA therapy
    E.2.2Secondary objectives of the trial
    • To determine the ischaemic lesion volume and brain oedema on 22-36h post-thrombolysis CT-scan in patients treated with exenatide (Byetta) compared to control
    • To examine the levels of neuronal damage and inflammation markers in patients treated with exenatide (Byetta) compared to control after stroke-thrombolysis
    • To investigate the mortality and functional independency at 3 months
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Acute ischemic stroke patient treated with intravenous thrombolysis
    2. Age 18 years or above
    3. Intravenous thrombolysis therapy is given within 4.5h of stroke onset.
    4. Plasma glucose between 7.1 and 9.9 mmol/L prior to start of intravenous thrombolysis
    5. Able to commence plasma glucose lowering regimen within 1 h of completion of intravenous thrombolysis therapy
    6. Able to be ‘actively’ treated and admitted to a monitored facility, such as an acute stroke unit, high dependency unit or intensive care unit.
    7. Informed consent from patient.
    E.4Principal exclusion criteria
    1. Previous known diabetes (type 1 or type 2 DM) or ongoing medication with any glucose-lowering agent.
    2. A very high likelihood that the patient will die within the next 24 h on the basis of clinical and/or radiological criteria (e.g. malignant media infarct).
    3. Patients expected to require endovascular or surgical intervention (e.g. i.a. thrombolysis or mechanical thrombectomy, carotid endarterectomy) during the treatment or follow-up period.
    4. Previous participation in this trial or current participation in another investigational stroke treatment clinical trial
    5. A high likelihood that the patient will not adhere to the study treatment and follow-up regimen
    6. Plasma glucose <=7.0 mmol/L or >=10.0 mmol/L
    7. Patients with lower level of consciousness (Glasgow Coma Scale <14, or NIHSS Item 1a=2 or RLS=2)
    8. Malignancy, Pregnancy, Recent invasive procedures, Traumatic injury, Persistent hypertension, Severe liver disease, Alcohol abuse,
    9. Refusal to consent.
    10. Suspected pharyngeal palsy, e.g. inability to swallow.
    11. Patients with dementia diagnosis
    12. Patients with dysphasia (NIHSS>0 in item 9) or Verbal response <5 in Glasgow Coma Scale)*
    13. Patients with known severe renal failure (creatinine clearance < 30 ml/min)
    *Patient may be included in case of mild dysphasia (NIHSS=1 in item 9) provided that the NIHSS is performed by a physician and a witness not involved in the trial verify that the patient fully understand information provided to be included in the trial and then gives consent.
    E.5 End points
    E.5.1Primary end point(s)
    • The primary safety outcome is a composite endpoint which is reached if any of the following events has occurred: Any serious or intolerable non-serious adverse events, death within 7 days, or symptomatic intracerebral haemorrhage (SICH) per SITS-MOST definition within 24 hours.
    • Primary feasibility/efficacy outcome: At least 80% of the plasma glucose measurements are within the target intervals (5-7 mmol/L) over time (72 hours) in each patient and if 80% (24 of 30) of patients in the treatment group fulfil this criterion.
    E.5.1.1Timepoint(s) of evaluation of this end point
    • Composite endpoint which is reached if any of the following events has occurred: Any serious or intolerable non-serious adverse events, death within 7 days, or symptomatic intracerebral haemorrhage (SICH) per SITS-MOST definition within 24 hours.
    • Primary feasibility/efficacy outcome: At least 80% of the plasma glucose measurements are within the target intervals (5-7 mmol/L) over time (72 hours) in each patient and if 80% (24 of 30) of patients in the treatment group fulfil this criterion.
    E.5.2Secondary end point(s)
    • Ischemic lesion volume and brain oedema determined on CT-scans at day 2
    • Pulse rate (measured every 4th hour from randomization to 72 hours after randomization)
    • Levels of markers of neuronal damage (i.e. S 100B)
    • Levels of markers of inflammation (i.e. hs-CRP, IL 6, PAI-1 and TNF-α)
    • SICH per ECASS-2 definition.
    • Functional independency as measured by modified Rankin scale (mRS) score of 0-2 at 3 months
    • Death within 3 months
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Ischemic lesion volume and brain oedema determined on CT-scans at day 2
    • Pulse rate (measured every 4th hour from randomization to 72 hours after randomization)
    • Levels of markers of neuronal damage (i.e. S 100B) after 24 hours
    • Levels of markers of inflammation (i.e. hs-CRP, IL 6, PAI-1 and TNF-α) after 24 hours
    • SICH per ECASS-2 definition.
    • Functional independency as measured by modified Rankin scale (mRS) score of 0-2 at 3 months
    • Death within 3 months
    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 No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Plasma glucose will be treated according to the standard practice for the centre.
    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 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 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 years1
    E.8.9.1In the Member State concerned months6
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2013-12-30. Yes
    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 Yes
    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 state40
    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
    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 Decision2014-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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