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    Summary
    EudraCT Number:2005-000421-34
    Sponsor's Protocol Code Number:PN01-01/CD 003
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-04-26
    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 ConcernedFinland - Fimea
    A.2EudraCT number2005-000421-34
    A.3Full title of the trial
    DESMOTEPLASE (INN) IN ACUTE ISCHAEMIC STROKE: PHASE III; A prospective, randomised, double-blind, placebo-controlled, single bolus, multinational, multi-centre, parallel group, dose ranging study of desmoteplase (INN) in the indication of acute stroke
    A.3.2Name or abbreviated title of the trial where available
    DIAS-2
    A.4.1Sponsor's protocol code numberPN01-01/CD 003
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPAION Deutschland GmbH
    B.1.3.4CountryGermany
    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 support
    B.4.2Country
    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
    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 DSPA
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 codeDSPA
    D.3.9.3Other descriptive namerDSPAalpha1; ZK 152 387; recombinant Desmodus rotundus salivary plasminogen activator
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12,5
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 ischaemic stroke
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10061256
    E.1.2Term Ischaemic stroke
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Main objective : The study objective is to further investigate the clinical efficacy and safety of two doses of desmoteplase (90 µg/kg and 125 µg/kg) administered as a single intravenous bolus to patients with acute ischaemic stroke within 3 – 9 hours after onset of symptoms.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Approximately 30 designated centres will participate in a sub-study with the aim to characterise further the pharmacokinetic profile, antibody formation, and to assess additional coagulation parameters.
    E.3Principal inclusion criteria
    1.Informed Consent (all sites) and HIPAA authorization (US sites only)
    2.Age 18 – 85 years
    3.Treatment onset within 3 - 9 hours after onset of stroke symptomsIf the exact onset of stroke is unclear, but the onset of stroke symptoms was less than 8 hours before arrival at the hospital, then the patient can be considered eligible for the study (this provides 1 hour for eligibility determination prior to receipt of randomized therapy). All measures should be taken so that treatment with alteplase within 3 hours of symptom onset is not delayed in patients who qualify for receiving alteplase.
    4.Score of 4 - 24 on the NIHSS with clinical signs of hemispheric infarction (e.g. hemiparesis) suggestive of ischemic stroke


    Inclusion Criterion from diagnostic imaging screening:A distinct penumbra (at least 20%), measured by MRI (PWI/DWI) or perfusion CT, related to middle cerebral artery (MCA), anterior cerebral artery (ACA) or posterior cerebral artery (PCA) territory in a hemispheric distribution
    E.4Principal exclusion criteria
    1.Previous participation in a desmoteplase study (i.e., DEEP, DIAS, DEDAS, DEPTH).
    2.Participation in any investigational study in the previous 30 days.
    3.Any terminal illness that is serious or advanced (patient is not expected to survive more than 1 year).
    4.Any condition that could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study (this applies to patients with severe microangiopathy such as hemolytic uremic syndrome or thrombotic thrombocytopenic purpura)The judgment is left to the discretion of the Investigator.
    5.Patients not able to receive study medication within 60 minutes after completion of diagnostic imaging screening.
    6.Pregnant women (positive serum βHCG pregnancy test, positive urine pregnancy test or clinically evident pregnancy).
    7.Rapidly improving neurological symptoms such that the rate of improvement is projected to give the patient an NIHSS score of < 4 at randomization.
    8.Pre-stroke MRS score of > 1 (indicating previous disability).
    8.1.Consciousness level > 2 on question 1a of NIHSS
    9.History or clinical presentation of ICH, subarachnoid hemorrhage (SAH), arterio-venous (AV) malformation, aneurysm, or cerebral neoplasm. Patients with incidental small intracranial aneurysm can be considered for the study if the aneurysm is < 5 mm, not thrombosed, and not visibly bleeding.
    10.Suspected acute vertebral or basilar artery occlusion.
    11.Current use of oral anticoagulants and a prolonged prothrombin time (INR > 1.6).
    12.Use of heparin, except for low dose subcutaneous heparin, in the previous 48 hours and a prolonged partial thromboplastin time exceeding the upper limit of the local laboratory normal range.
    13.Use of glycoprotein IIb - IIIa inhibitors within the past 72 hours. Use of single agent oral platelet inhibitors (clopidogrel or low-dose aspirin) prior to study entry is permitted.
    14.Baseline platelet count < 100,000/mm³.
    15.Baseline hematocrit of < 0.25.
    16.Baseline blood glucose < 50 mg/dl or > 300 mg/dl (< 3 mmol/l or > 17 mmol/l). Patients with blood glucose value between 200-300 mg/dL can be considered for the study only if the blood glucose value decreases to < 200 mg/dl after antidiabetic treatment and before administration of study medication.
    17.Uncontrolled hypertension defined by a blood pressure > 185 mmHg systolic or >110 mmHg diastolic on at least 2 separate occasions at least 10 minutes apart, or requiring aggressive treatment to reduce the blood pressure within the limitsThe definition of “aggressive treatment” is left to the discretion of the responsible Investigator.
    18.Hereditary or acquired hemorrhagic diathesis.
    19.Gastrointestinal or urinary bleeding within the preceding 21 days.
    20.Arterial puncture at a non-compressible site within the previous 7 days.
    21.Another stroke or a serious head injury in the previous 6 weeks.
    22.Any history of prior stroke in a patient with diabetes unless the blood glucose is within the range indicated above.
    23.Major surgery within the preceding 14 days.
    24.Seizure at the onset of stroke.
    25.Acute myocardial infarction (AMI) within the previous 3 weeks.
    26.Exposure to a thrombolytic within the previous 72 hours.
    27.Any intracranial pathology that would interfere with the assessment of the chosen imaging technique for screeningExclusion criteria from diagnostic imaging screening:
    28.Extensive early infarction in any affected area defined by an infarcted core involving >1/3 of MCA territory or the entire ACA territory.
    29.Imaging evidence of ICH or SAH (regardless of age); 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 criteria).
    30.Well developed parenchymal hyperintensity on FLAIR, T2*, or EPI-T2 images, or marked hypodensity on CT, indicative of subacute infarction or enhancement, with morphologic features suggesting the lesion is more than 9 hours old.
    31.Internal carotid artery occlusion on the side of the stroke lesion.
    32.Any contraindication to imaging technique i.e. ferromagnetic objects for MRI, contraindications to contrast agent, kidney disease with iodinated contrast agent in perfusion CT, etc. Refer to the Imaging Manual for contraindications to imaging technique.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy parameter is clinical improvement at Day 90 defined for each patient as achievement of all three of the following: (1) Improvement of > = 8 points from baseline on the National Institutes of Health Stroke Scale (NIHSS) (or NIHSS score < = 1), (2) Modified Rankin Scale (MRS) score of 0 – 2, and (3) Barthel Index (BI) score of 100 – 75.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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.8.3 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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    last patient last visit
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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.1.3Elderly (>=65 years) Yes
    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 2005-04-26. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women Yes
    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
    aphasic patients
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 115
    F.4.2.2In the whole clinical trial 196
    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)
    After 90 days follow-up, the patient will receive the expected normal treatment for acute ischaemic stroke.
    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 Decision2005-09-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-05-27
    P. End of Trial
    P.End of Trial StatusCompleted
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