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    Summary
    EudraCT Number:2011-005541-12
    Sponsor's Protocol Code Number:2011-397
    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:2012-02-27
    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 number2011-005541-12
    A.3Full title of the trial
    Efficacy of escitalopram treatment in acute stroke and the role of SERT genotype in stroke
    Effekten af escitalopram-behandling ved akut stroke og SERT genets betydning for stroke
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of escitalopram treatment i acute stroke and the role of specific genotypes in stroke
    Effekekten af escitalopram-behandling ved akut slagtilfælde og arvemassens betydning for slagtilfælde
    A.3.2Name or abbreviated title of the trial where available
    ESTIAS
    ESTIAS
    A.4.1Sponsor's protocol code number2011-397
    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 SponsorGrethe Andersen
    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 supportLundbeck Pharma
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAarhus University Hospital
    B.5.2Functional name of contact pointNeurology Department
    B.5.3 Address:
    B.5.3.1Street AddressNørrebrogade 44
    B.5.3.2Town/ cityÅrhus
    B.5.3.3Post code8000
    B.5.3.4CountryDenmark
    B.5.4Telephone number004589493294
    B.5.5Fax number004589493300
    B.5.6E-mailgreander@rm.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 Yes
    D.2.1.1.1Trade name Cipralex
    D.2.1.1.2Name of the Marketing Authorisation holderH. Lundbeck A/S, Valby - Copenhagen, Denmark
    D.2.1.2Country which granted the Marketing AuthorisationPortugal
    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 Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Stroke
    Iskæmisk apopleksi
    E.1.1.1Medical condition in easily understood language
    Stroke
    Slagtilfælde
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10055221
    E.1.2Term Ischemic 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
    The main objective is to examine whether escitalopram treatment in acute stroke reduces the risk of re-stroke and myocardial infarction
    Hovedformålet er at undersøge om escitalopram behandling ved akut stroke reducerer forekomsten af nye iskæmiske tilfælde
    E.2.2Secondary objectives of the trial
    Secondary objective is to examine whether escitalopram treatment in acute stroke improves physical and cognitive function.
    Det sekundære formål er at undersøge, om escitalopram behandling ved akut stroke forbedrer det motoriske og kognitive funktionsniveau.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    SERT genotype related to stroke, 15.1.12, version 1, revison 4. The objective is to examine the polymorphisms of the SERT gene as a risk factor in stroke and as a possible determinant in the development of post stroke depression.
    SERT genets betydning for stroke, 15.1.12, version 1, revision 4. Formålet er at undersøge SERT genets polymorfier som risikofaktor for stroke og som mulig determinant for udviklingen af post-stroke depression.
    E.3Principal inclusion criteria
    Age over 18 years
    Clinically verified first ever ischemic stroke
    Alder over 18 år
    Klinisk verificeret førstegangs stroke
    E.4Principal exclusion criteria
    Hemoragic stroke
    Dementia
    Antidepressant treatment within 30 days prior to inclusion
    Contraindications to SSRI treatment
    Liver/renal failure
    QTc prolongation (more than 500 ms)
    Hæmoragisk stroke
    Demens
    Antidepressiv behandling indenfor 30 dage forud for inklusion
    Kontraindikationer for SSRI behandling
    Lever/nyre påvirkning
    QTc forlængelse (over 500 ms)
    E.5 End points
    E.5.1Primary end point(s)
    Combined vascular mortality
    Myocardial infarction
    Re-stroke
    Kombineret vaskulær død
    AMI
    Re-stroke
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months after inclusion
    6 måneder efter inklusion
    E.5.2Secondary end point(s)
    Mortality
    Vascular mortality
    Myocardial infarction
    Re-stroke
    Subclinical cerebral ischemic lesions
    Physical and cognitive skills
    Post stroke depression
    Pathological crying
    Fatique
    Død
    Vaskulær død
    AMI
    Re-stroke
    Subkliniske cerebrale iskæmiske tilfælde
    Fysisk og intellektuel funktionsevne
    Post stroke depression
    Patologisk gråd
    Træthed
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 and 6 months
    1 og 6 måneder
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 concerned3
    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
    Sidste forsøgsdeltager, sidste besøg
    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 months0
    E.8.9.1In the Member State concerned 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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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 Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    We plan to include subjects incapable of giving consent personally due to their stroke: Aphatic patients, patients with impaired consciousness due to ceberal oedema and patients with weakend motor skills incapable of signing the concent form.
    Vi planlægger at inkludere forsøgsdeltagere som ikke selv kan afgive informeret samtykke pga deres stroke: Afatiske patienter, patienter med svækket bevidsthed pga cerebralt ødem og patienter der pga fysisk handicap ikke kan skrive under.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state600
    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 Decision2012-02-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2012-06-11
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