Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7293   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2018-001279-19
    Sponsor's Protocol Code Number:SONAS2018
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-10-29
    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 ConcernedAustria - BASG
    A.2EudraCT number2018-001279-19
    A.3Full title of the trial
    Evaluation of the SONAS® ultrasound device for the assessment of bilateral cerebral perfusion in subjects with acute stroke
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the SONAS® ultrasound device for the assessment of
    blood flow in the two sides of the brain in subjects with acute stroke
    A.4.1Sponsor's protocol code numberSONAS2018
    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 SponsorBURL Concepts, Inc.
    B.1.3.4CountryUnited States
    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 supportBURL Concepts, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBURL Concepts, Inc.
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street Address11545 Sorrento Valley Road, Suite 312
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post code92121
    B.5.3.4CountryUnited States
    B.5.4Telephone number001619277 3702
    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 SonoVue
    D.2.1.1.2Name of the Marketing Authorisation holderBracco International B.V.
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameSonovue
    D.3.4Pharmaceutical form Powder and solvent for dispersion for injection
    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.3.9.1CAS number 2551-62-4
    D.3.9.3Other descriptive nameSULFUR HEXAFLUORIDE
    D.3.9.4EV Substance CodeSUB15925MIG
    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
    Acute stroke (NIHSS score: ≥ 6)
    E.1.1.1Medical condition in easily understood language
    Moderate or major acute stroke
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10042244
    E.1.2Term 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 determine the safety and feasibility of detecting acoustic signals related to blood supply in subjects with acute stroke by using the SONAS® device.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent obtained
    2. Male or female aged at least 18
    3. Clinical diagnosis of acute stroke (NIHSS score: ≥6)
    4. Time of stroke symptoms onset: ≤24 hours
    5. Assessment of the intracranial arterial circulation (ACA, MCA, PCA, distal ICA) by cMRI or cCT (including perfusion weighted imaging sequences)
    6. Women of childbearing potential must have a negative urine or serum beta human chorionic gonadotropin result, obtained within 24 hours before administration of SonoVue®
    7. Women of non-childbearing potential can be included in the clinical investigation, if confirmed by fulfilling at least 1 of the following criteria:
    • Postmenopausal (age-related amenorrhea for ≥12 consecutive months)
    • Documentation (based on medical records, medical examination, or medical history interview) of irreversible surgical sterilization by bilateral oophorectomy, bilateral salpingectomy, or hysterectomy
    E.4Principal exclusion criteria
    1. Subjects with known contraindications to the use of SonoVue®:
    • Subjects known to have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure >90 mmHg), uncontrolled systemic hypertension, and subjects with acute respiratory distress syndrome
    • SonoVue® must not be used in combination with dobutamine in subjects with conditions suggesting cardiovascular instability where dobutamine is contraindicated
    • Known hypersensitivity to any of the following substances:
    o Sulphur hexafluoride
    o Macrogol 4000
    o Distearoylphosphatidylcholine
    o Dipalmitoylphosphatidylglycerol sodium
    o Palmitic acid
    2. Pregnant women
    3. Subjects with severe cardiac or pulmonary disease as defined by the treating physician
    4. Subjects with acute endocarditis and/or artificial heart valve
    5. Subjects with acute systemic inflammation and/or sepsis
    6. Subjects with hyperactive coagulation states and/or a recent thromboembolism
    7. Subjects with end stage renal or hepatic disease
    8. Subjects with known metal skull implants in the anatomical area of the temporal/parietal bones, or with anatomical formation of the head or ear that may interfere with proper headset placement, or with significant observable asymmetry in head formation
    9. Subjects with known implanted deep brain stimulation devices
    10. Subjects with known or suspected fracture(s) of the temporal/parietal skull bones, or with open skin injuries in the anatomical area of the temporal/parietal lobes
    11. Subjects with known significant blood loss prior to or during the test procedure, SONAS® should not be used unless the blood pressure of the subject is verified to be stabilized
    12. Subjects with axial (coronal) skull diameters of <12 cm or >18 cm
    13. Subjects participating in another clinical investigation with an investigational drug or device within 3 months of enrollment or planned participation at any time during this clinical investigation
    14. Previous participation in this clinical investigation
    15. Employees of the clinical investigation site or the sponsor directly involved with the conduct of the clinical investigation, or immediate family members of any such individuals
    16. Subjects committed to an institution by an order issued either by the courts or by an authority
    E.5 End points
    E.5.1Primary end point(s)
    • Measurement of the kinetic parameter time to peak (TTP) in the right and left brain hemisphere during the SONAS® test
    • Assessment of intra-individual differences in the parameter TTP in the right and left brain hemisphere during the SONAS® test
    • Comparison between SONAS® versus cMRI or cCT generated intra-individual differences in the parameter TTP in the right and left brain hemisphere
    • Measurement of other kinetic parameters (e.g. TI, TA, hPmax_incline, Pmax, hPmax_recede, 80%Pmax_recede, and MTT) in the right and left brain hemisphere during the SONAS® test and evaluations as defined for TTP
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 0; day 1 (24 hours after first SONAS test)
    E.5.2Secondary end point(s)
    Frequency, severity, relationship (device, contrast agent, or procedure) and outcome of adverse events (AEs)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 0; day 1 (24 hours after first SONAS test); day 4 (72 hours after first SONAS test)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    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 Yes
    E.6.13.1Other scope of the trial description
    To determine the safety and feasibility of detecting acoustic signals, enhanced by injection of Sonovue contrast agent, related to blood supply in subjects with acute stroke by using the SONAS® device.
    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 No
    E.8.1.1Randomised No
    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 No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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 No
    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 visit of the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 2018-10-29. 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 No
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-02-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-12-29
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Wed May 08 22:23:47 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA