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    Summary
    EudraCT Number:2012-000512-29
    Sponsor's Protocol Code Number:IIBSP-SPM-2011-63
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-04-17
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2012-000512-29
    A.3Full title of the trial
    Sonothrombolysis potentiated by microbubbles as a novel treatment of acute ischemic stroke: a prospective randomized pilot study
    Sonotrombolisis potenciada por microburbujas como tratamiento nuevo del ictus isquémico agudo. Estudio piloto, aleatorizado y prospectivo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Sonothrombolysis potentiated by microbubbles as a novel treatment of acute ischemic stroke: a prospective randomized pilot study
    Sonotrombolisis potenciada por microburbujas como tratamiento nuevo del ictus isquémico agudo. Estudio piloto, aleatorizado y prospectivo
    A.3.2Name or abbreviated title of the trial where available
    SONOVUE
    SONOVUE
    A.4.1Sponsor's protocol code numberIIBSP-SPM-2011-63
    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 SponsorInstitut de Recerca Hospital Sant Pau
    B.1.3.4CountrySpain
    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 supportTV3 Grants
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recerca Hospital sant Pau
    B.5.2Functional name of contact pointRomy Rodríguez
    B.5.3 Address:
    B.5.3.1Street AddressC. Sant Antoni Mª Claret, 167
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08025
    B.5.3.4CountrySpain
    B.5.4Telephone number00349329190001969
    B.5.5Fax number0034935537812UK
    B.5.6E-mailRRodriguezMu@santpau.cat
    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, Italy
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.2Product code EU/1/01/177/002
    D.3.4Pharmaceutical form Powder and solvent for suspension 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.3.10 Strength
    D.3.10.1Concentration unit µl microlitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number24
    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 Yes
    D.3.11.13.1Other medicinal product typecontrast agent
    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 ischemic brain stroke
    Ictus isquémico agudo
    E.1.1.1Medical condition in easily understood language
    Acute cerebral infarction
    Infarto cerebral agudo
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate in a pilot study the safety and efficacy of common diagnostic sulfur hexafluorid MBs on the beginning, degree, and time to maximum completeness of middle cerebral artery (MCA) recanalization during systemic thrombolysis and continuous 2-Hz pulsed-wave TCD monitoring.
    Evaluar la seguridad y eficacia del tratamiento con sonotrombolisis potenciado con MB en pacientes con infarto cerebral agudo
    E.2.2Secondary objectives of the trial
    1 To investigate whether the administration of ST plus MB treatment leads to an increase in the proportion of patients with MCA ischemic stroke that achieve an early clinical improvement (decrease in 4 or more points at at 24 h NIHSS) and good long-term functional outcome (Modified Rankin Scale 0-1 at 3 months), when compared to patients treated with standard treatment.

    2 To assess the safety of ST plus MB treatment, in terms of mortality and of Hemorrhagic transformation rate (symptomatic and asymptomatic), within the first 3 month after treatment. Death from any cause will be recorded.
    Valorar el pronostico a corto y largo plazo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The main inclusion criteria will be:
    - All acute (<4,5 hours) ischemic stroke patients in the MCA territory (as depicted by head computed tomography CT or suspected by clinical data) with a disabling neurological deficit measurable by National Institute of Health Stroke Scale (NIHSS) score, that in the opinion of treating physicians require and meet accepted criteria of treatment with a standard 0.9mg/kg dose of iv rtPA.
    - A documented occlusion of the middle cerebral artery (MCA) documented by TCD and/or angioCT.
    -The patient or the legal representative signs the written consent to participate
    -Age ? 18 years
    -No significant improvement before treatment.
    -The treatment is initiated within 90 minutes of hospital admission (door-to-needle time ? 90 minutes)
    -There is no limitation regarding the NIHSS score. Scores under 5 are usually considered mild strokes, but they can be treated if the investigator believes that the measured deficit is important enough to cause disability. The investigator should weight benefits and risks when the score is under 5 and above 22.
    The main inclusion criteria will be:
    - All acute (<4,5 hours) ischemic stroke patients in the MCA territory (as depicted by head computed tomography CT or suspected by clinical data) with a disabling neurological deficit measurable by National Institute of Health Stroke Scale (NIHSS) score, that in the opinion of treating physicians require and meet accepted criteria of treatment with a standard 0.9mg/kg dose of iv rtPA.
    - A documented occlusion of the middle cerebral artery (MCA) documented by TCD and/or angioCT.
    -The patient or the legal representative signs the written consent to participate
    -Age ? 18 years
    -No significant improvement before treatment.
    -The treatment is initiated within 90 minutes of hospital admission (door-to-needle time ? 90 minutes)
    -There is no limitation regarding the NIHSS score. Scores under 5 are usually considered mild strokes, but they can be treated if the investigator believes that the measured deficit is important enough to cause disability. The investigator should weight benefits and risks when the score is under 5 and above 22.
    E.4Principal exclusion criteria
    Patients will be excluded if they have 1 or more of the following:
    -severe stroke as indicated on baseline CT imaging or by a NIHSS score > 25
    -evidence of hemorrhage on noncontrast head computed tomography CT),
    -any other standard contraindication for intravenous rtPA therapy,
    -primary treatment with intra-arterial thrombolysis,
    -Previous Rankin scale score > 1 and NIHSS < 14 or previous Rankin scale score >2 and NIHSS ? 14
    - Rapidly improving neurological symptoms such that the rate of improvement is expected to result in a NIHSS score of <4 at randomization
    - Coexisting neurological diseases such as dementia or life-threatening illness.
    - Seizure at symptom onset
    - History or clinical presentation of intracranial hemorrhage, subarachnoid hemorrhage (even with a normal CT), arteriovenous malformation, aneurysm, spinal cord disease or cerebral neoplasm. Incidental meningioma and microbleeds per se are not exclusion criteria.

    - Baseline blood glucose concentration less than 50 mg/dL or greater than 400 mg/dl, that cannot be corrected
    - Uncontrolled hypertension, defined as systolic blood pressure >185 mm Hg or diastolic blood pressure >110 mm Hg on at least two separate occasions at least 10 min apart, or blood pressure that requires aggressive treatment to reduce it to within these limits
    - Hereditary or acquired hemorrhagic diathesis
    - Another stroke, a serious head injury or major surgery within the previous 3 month
    -Platelet count < 100.000/mm3
    -Hemorrhagic retinopathy
    -Within 10 days of traumatic external heart massage, obstetrical delivery, recent puncture of a non-compressible blood-vessel
    -Bacterial endocarditis, pericarditis
    -Acute pancreatitis; documented ulcerative gastrointestinal disease during the last 3 months, esophageal varices
    -Arterial aneurysm, arterial/venous malformations
    -Neoplasm with increased bleeding risk
    -Severe liver disease, including hepatic failure, cirrhosis, portal hypertension and active hepatitis
    -Major surgery or significant trauma in past 3 months
    - Contraindication to CT perfusion: Iodinated contrast allergy, renal insufficiency (elevated serum creatinine above normal laboratory levels at each center), non-collaborative patients, pregnancy

    -Contraindication based on CT:
    Intracerebral or subarachnoid haemorrhage, arteriovenous malformation, cerebral aneurysm, tumour or non-ischaemic lesions mimicking stroke.
    Infarct core of more than 2/3 of middle cerebral artery territory or all of anterior cerebral artery territory.
    Any other contraindication to the imaging technique.
    Patients will be excluded if they have 1 or more of the following:
    -severe stroke as indicated on baseline CT imaging or by a NIHSS score > 25
    -evidence of hemorrhage on noncontrast head computed tomography CT),
    -any other standard contraindication for intravenous rtPA therapy,
    -primary treatment with intra-arterial thrombolysis,
    -Previous Rankin scale score > 1 and NIHSS < 14 or previous Rankin scale score >2 and NIHSS ? 14
    - Rapidly improving neurological symptoms such that the rate of improvement is expected to result in a NIHSS score of <4 at randomization
    - Coexisting neurological diseases such as dementia or life-threatening illness.
    - Seizure at symptom onset
    - History or clinical presentation of intracranial hemorrhage, subarachnoid hemorrhage (even with a normal CT), arteriovenous malformation, aneurysm, spinal cord disease or cerebral neoplasm. Incidental meningioma and microbleeds per se are not exclusion criteria.

    - Baseline blood glucose concentration less than 50 mg/dL or greater than 400 mg/dl, that cannot be corrected
    - Uncontrolled hypertension, defined as systolic blood pressure >185 mm Hg or diastolic blood pressure >110 mm Hg on at least two separate occasions at least 10 min apart, or blood pressure that requires aggressive treatment to reduce it to within these limits
    - Hereditary or acquired hemorrhagic diathesis
    - Another stroke, a serious head injury or major surgery within the previous 3 month
    -Platelet count < 100.000/mm3
    -Hemorrhagic retinopathy
    -Within 10 days of traumatic external heart massage, obstetrical delivery, recent puncture of a non-compressible blood-vessel
    -Bacterial endocarditis, pericarditis
    -Acute pancreatitis; documented ulcerative gastrointestinal disease during the last 3 months, esophageal varices
    -Arterial aneurysm, arterial/venous malformations
    -Neoplasm with increased bleeding risk
    -Severe liver disease, including hepatic failure, cirrhosis, portal hypertension and active hepatitis
    -Major surgery or significant trauma in past 3 months
    - Contraindication to CT perfusion: Iodinated contrast allergy, renal insufficiency (elevated serum creatinine above normal laboratory levels at each center), non-collaborative patients, pregnancy

    -Contraindication based on CT:
    Intracerebral or subarachnoid haemorrhage, arteriovenous malformation, cerebral aneurysm, tumour or non-ischaemic lesions mimicking stroke.
    Infarct core of more than 2/3 of middle cerebral artery territory or all of anterior cerebral artery territory.
    Any other contraindication to the imaging technique.
    E.5 End points
    E.5.1Primary end point(s)
    Recanalization rate - TIBI score
    Tasa de recanalización arterial
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 hour and 6 hours
    1 y 6 horas
    E.5.2Secondary end point(s)
    Short term clinical outcome
    Long term clinical outcome
    Mortality
    Pronóstico corto plazo
    pronóstico largo plazo
    mortalidad
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 hours and 3 months
    24 horas y 3 meses
    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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    tratamiento trombolítico estandar
    standard thrombolytic treatment
    E.8.2.4Number of treatment arms in the trial2
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 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
    The study ends with the 90-days follow-up visit, in which the long term outcome is obtained.
    In this last visit the Rankin scale score is obtained. Also, the investigator must obtain the NIHSS score, record concomitant medication and adverse events and check vital signs.
    The study ends with the 90-days follow-up visit, in which the long term outcome is obtained.
    In this last visit the Rankin scale score is obtained. Also, the investigator must obtain the NIHSS score, record concomitant medication and adverse events and check vital signs.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 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 No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    In aphasic patients, informed consent will be offered to the familiy
    In aphasic patients, informed consent will be offered to the familiy
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    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)
    Standard treatment and follow-up
    Tratamiento estandar y normal seguimiento
    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 Decision2012-06-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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