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    Summary
    EudraCT Number:2008-005539-14
    Sponsor's Protocol Code Number:12649A
    National Competent Authority:Estonia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-04-11
    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 ConcernedEstonia - SAM
    A.2EudraCT number2008-005539-14
    A.3Full title of the trial
    A randomised, double-blind, parallel-group, placebo-controlled phase III study to evaluate the efficacy and safety of desmoteplase in subjects with acute ischemic stroke.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Stroke
    A.3.2Name or abbreviated title of the trial where available
    DIAS-4
    A.4.1Sponsor's protocol code number12649A
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00856661
    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 SponsorH. Lundbeck A/S
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportH. Lundbeck A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    B.5.6E-mailLundbeckClinicalTrials@lundbeck.com
    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 namedesmoteplase
    D.3.2Product code Lu-AE03329
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdesmoteplase
    D.3.9.1CAS number 145137-38-8
    D.3.9.2Current sponsor codeLu-AE03329
    D.3.9.3Other descriptive nameRecombinant Desmodus Salivary Plasminogen Activator alpha 1, rDSPAα17
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeRecombinant therapeutic protein
    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 placeboPowder for solution for injection
    D.8.4Route of administration of the placeboIntravenous bolus use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute ischemic stroke within 3 - 9 hours after the onset of symptoms.
    E.1.1.1Medical condition in easily understood language
    Stroke
    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 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of desmoteplase 90 µg/kg versus placebo in terms of favourable outcome at Day 90 in subjects with acute ischemic stroke.
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of 90 µg/kg desmoteplase versus placebo in terms of favourable outcome at Day 7/discharge and Day 30 in subjects with acute ischemic stroke
    • To evaluate the efficacy of 90 µg/kg desmoteplase versus placebo in terms of favourable outcome at Day 90 in the subgroup of subjects with a baseline core-lesion volume < 25 cc
    • To evaluate recanalisation associated with 90 µg/kg desmoteplase versus placebo in the subgroup of subjects with follow up angiography at 12-24 hours
    • To evaluate the safety and tolerability of desmoteplase
    • To evaluate the mortality in the treatment groups
    • To evaluate the incidence of symptomatic intracranial haemorrhage (sICH)
    • To evaluate the immunogenicity of desmoteplase
    • To evaluate the pharmacokinetics/pharmacodynamics of desmoteplase
    • To evaluate the impact of treatment on subjects’ quality of life
    • To evaluate the impact of treatment on utilization of resources
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Clinical diagnosis of acute ischemic stroke
    • Informed consent has been obtained according to a procedure approved by the ethics committee responsible for approval of the study at this site
    • Male or female between 18 and 85 years of age inclusive.
    • Treatment of the subject can be initiated within 3-9 hours after the onset of stroke symptoms. If the actual time of onset of stroke is unclear then the onset will be considered the time that the subject was last known to be well. All measures are to be taken, so treatment with alteplase within 3 hours of symptom onset is not delayed in subjects who qualified for receiving alteplase
    • The subject has a score of 4-24 inclusive on the NIHSS with clinical signs of hemispheric infarction (for example, hemiparesis)
    • The subject shows occlusion or high-grade stenosis as assessed by MRA or CTA in proximal cerebral arteries that correspond to the acute clinical deficit. Eligible vessels are the Middle Cerebral Artery (MCA) M1, MCA M2, anterior cerebral artery (ACA) or posterior cerebral artery (PCA)
    • The subject must receive IMP within 60 minutes after completion of diagnostic imaging screening. The time stamp on the last imaging sequence is the reference for calculating the time elapsing.
    E.4Principal exclusion criteria
    • The subject has a pre-stroke mRS > 1 indicating previously disability
    • The subject has previously been exposed to desmoteplase
    • The subject shows signs of extensive early infarction on MRI or CT in any affected area, that is an infarcted core involving > 1/3 of MCA territory or > 1/2 of the ACA or PCA territories
    • The subject has imaging evidence of ICH or SAH (regardless of age of the bleeding); AV malformation; cerebral aneurysm; or cerebral neoplasm (incidental meningioma and microbleeds per se are not exclusion criteria. An incidental intracranial aneurysm that is small (< 5 mm), not thrombosed, and not visibly bleeding is not an exclusion criterion).
    • The subject has an internal carotid artery occlusion on the side of the stroke lesion
    • The subject has been treated with heparin in the past 48 hours and has a prolonged partial thromboplastin time exceeding the upper limit of the local laboratory normal range. Preventive low doses of LMWH (for example, for deep vein thrombosis (DVT) prophylaxis) do not disqualify the subject from the study
    • The subject is on oral anticoagulants and has a prolonged prothrombin time (INR > 1.6)
    • The subject has been treated with glycoprotein IIb - IIIa inhibitors within the past 72 hours. Use of single agent oral platelet inhibitors (e.g. low-dose clopidogrel 75 mg or low-dose aspirin ≤325 mg) or the combination of low-dose-aspirin (e.g. 50 mg) and dipyridamole (e.g. 400 mg) prior to study entry is permitted
    • The subject has in the past 72 hours been treated with factor Xa inhibitors, direct thrombin inhibitors, or any anticoagulants other than those specified in exclusion criteria 9 and 10.
    • The subject has been treated with a thrombolytic agent within the past 72 hours
    E.5 End points
    E.5.1Primary end point(s)
    Favourable outcome at Day 90 defined as achieving 0-2 on mRS.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 90
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 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 Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Brazil
    Canada
    Denmark
    Finland
    Mexico
    United States
    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
    As defined in protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 250
    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 2013-04-11. 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Other patients incapable of fully understanding the meaning of the information due to stroke can be enrolled by proxy.
    In case of no proxy, treating physican and a study-indepedent physician may enrol the patient.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 262
    F.4.2.2In the whole clinical trial 400
    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)
    N/A
    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 Decision2013-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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