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    Summary
    EudraCT Number:2013-001989-42
    Sponsor's Protocol Code Number:TEA-Stroke
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-08-02
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2013-001989-42
    A.3Full title of the trial
    Theophylline Effect in Acute Ischemic Stroke Trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Theophylline Effect in Acute Ischemic Stroke Trial
    A.3.2Name or abbreviated title of the trial where available
    TEA-Stroke Trial
    A.4.1Sponsor's protocol code numberTEA-Stroke
    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 SponsorBoris Modrau
    B.1.3.4CountryDenmark
    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 supportAalborg University Hospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAalborg University Hospital
    B.5.2Functional name of contact pointTEA-Stroke Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressLadegaardsgade 5
    B.5.3.2Town/ cityAalborg
    B.5.3.3Post code9000
    B.5.3.4CountryDenmark
    B.5.4Telephone number4597 66 22 71
    B.5.5Fax number4597 66 22 18
    B.5.6E-mailaalborguh@rn.dk
    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 nameTeofylamin 22mg/ml
    D.3.2Product code 88013322012
    D.3.4Pharmaceutical form Infusion
    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 INNTHEOPHYLLINE MONOHYDRATE
    D.3.9.4EV Substance CodeSUB15520MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number220
    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 placeboInfusion
    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
    Acute ischemic stroke patients eligible for standard intravenous recombinant tissue plasminogen activator (rtPA) thrombolytic therapy with magnet resonance imaging (MRI)-proved infarction
    E.1.1.1Medical condition in easily understood language
    Acute stroke patients eligible for medical treatment to breakdown the blood clot
    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 LLT
    E.1.2Classification code 10023027
    E.1.2Term Ischaemic stroke NOS
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of this study is to evaluate safety and efficacy of add-on Teofylin treatment to standard thrombolytic therapy in patients with MR-proved acute ischemic stroke. The study is designed as a randomized controlled trial comparing add-on Teofylin to placebo. The main interests are to demonstrate the tissue effect of Teofylin by measuring the infarct growth assessed by multimodal MRI as well as improved early clinical outcome
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: Tissue effect of Teofylin by measuring the salvage of penumbra assessed by multimodal MRI as well as improved early clinical outcome
    Objective: The main objective of this study is to evaluate safety and efficacy of add-on Teofylin treatment to standard thrombolytic therapy in patients with MR-proved acute ischemic stroke and DWI/PWI-mismatch suspicious for penumbra (brain tissue at risk).
    The main interests are to demonstrate the tissue effect of Teofylin by measuring the salvage of penumbra assessed by multimodal MRI as well as improved early clinical outcome
    E.3Principal inclusion criteria
    •Subjects eligible for standard dose IV rtPA thrombolytic therapy within 4.5 hours of symptom onset in accordance to the national Danish inclusion /exclusion criteria for standard IV rtPA thrombolytic therapy
    •Patients with acute hemispheric cerebral infarction as defined by DWI.
    •National Institute of Health Stroke Scale (NIHSS) ≥4
    •DWI lesion volume ≤1/3 of MCA territory or ≤1/2 of ACA or PCA territory
    •Informed consent obtained.
    E.4Principal exclusion criteria
    •Age below 18 years
    •Pre-stroke disability defined by modified Rankin Scale (mRS) >1
    •Contraindication to MRI
    •Acute infarction of the brainstem on diffusion weighted MRI at baseline
    •Occlusion of the internal carotid artery or carotid-T on MRI at baseline
    •Epilepsy and/or acute seizure
    •Treatment with or allergic reaction to xanthines (Teofylin or its derivates)
    •Pregnancy, breastfeeding, or positive pregnancy test (Negative pregnancy test prior to Teofylin administration required in fertile women up to 55 years of age)
    •History of liver disease and/or alanine transaminase two times normal value
    •History of thyroidal dysfunction
    •Fever of more than 38.5 °C
    •Potassium below normal value
    •Electrocardiogram with signs of acute ischemic heart disease
    •Congestive heart failure, or acute myocardial infarction within the last 6 months
    •Reduced cooperation or other conditions that make it unlikely to precede the study or to follow the patient for three months
    •Participation in any interventional study within the last 30 days
    E.5 End points
    E.5.1Primary end point(s)
    Dual Primary Outcome Measures
    •Infact growth at 22-32 hours after add-on Teofylin treatment
    •Clinical improvement at 22-32 hours after add-on Teofylin treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    22-32 hours after add-on Teofylin treatment
    E.5.2Secondary end point(s)
    •Major clinical improvement 22-32 hours after add-on Teofylin treatment: Major clinical improvement is defined by ≥50% improvement in the NIHSS.
    •Recanalization rate from baseline to 22-32 hours after add-on Teofylin treatment: The recanalization rate is defined as change of the thrombolysis in myocardial infarction (TIMI) score 0 or 1 at baseline to TIMI at 22-32 hours.
    •Dichotomized favourable functional outcome: Dichotomized functional outcome at day 90±14 defined by the modified Rankin scale (mRS), which has a range of 0 to 6, with 0 indicating no symptoms at all and 6 indicating death: The secondary endpoint is dichotomized as favourable functional outcome (mRS score of 0 or 1) or unfavourable functional outcome (mRS score of 2 to 6).
    •Categorical shift in functional outcome: Functional outcome measures with the categorical shift (ordinal analysis) of the mRS at day 90±14.
    •A subgroup analysis for the primary and secondary endpoints will be performed for subjects with and without persistent symptomatic vessel occlusion, for subjects with non-lacunar infarction, and for subjects with endovascular therapy IV rtPA treatment (bridging theray). Subjects recruited in accordance to the TEA-Stroke protocol version 4.2 will be analysed per protocol version 4.2 for all endpoints as substudy analysis

    Safety Outcome Measures
    •Death within 90±14 days
    •Parenchyma hematoma type I or II (PH-1 or PH-2) at 22-32 hours on brain imaging
    •Symptomatic intracerebral haemorrhage (ICH) as a combined clinical/imaging endpoint defined by parenchyma hematoma type II (PH-2) on brain imaging and a clinical assessment with a decline ≥4 on NIHSS or death.
    E.5.2.1Timepoint(s) of evaluation of this end point
    22-32 hours, and day 90±14 after add-on Teofylin treatment
    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 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 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 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 years2
    E.8.9.1In the Member State concerned months9
    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: 80
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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)
    According to routine clinical practice, all subjects treated with standard dose IV rtPA stay in hospital for monitoring and control brain scan for at least 22-32 hours, disregarding study participation. All subjects will be admitted and monitored on a specialized unit for treatment of acute stroke patients. No standard of care will be withheld from the participant and each subject enrolled to the study will receive best medical treatment at any time during the study.
    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 Decision2013-08-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-03-12
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