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    Summary
    EudraCT Number:2010-024087-17
    Sponsor's Protocol Code Number:MAG104615
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-08-25
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2010-024087-17
    A.3Full title of the trial
    Study MAG104615, a Proof of Concept Study for GSK249320
    versus placebo in Stroke Patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To see if the study drug, GSK249320, works in patients who have had a stroke.
    A.3.2Name or abbreviated title of the trial where available
    POC in patients with ischaemic stroke
    A.4.1Sponsor's protocol code numberMAG104615
    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 SponsorGlaxoSmithKline Research & Development Ltd
    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 supportGlaxoSmithKline Research & Development Ltd
    B.4.2CountryChina
    B.4.1Name of organisation providing supportGSK
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportGSK
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointClincial Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road, Stockley Park west
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11 - 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44208990 44 66
    B.5.5Fax number+44208990 12 34
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 nameGSK249320
    D.3.2Product code GSK249320
    D.3.4Pharmaceutical form Solution for infusion
    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.3.9.2Current sponsor codeGSK249320
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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 placeboInjection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Stroke
    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 14.0
    E.1.2Level LLT
    E.1.2Classification code 10023027
    E.1.2Term Ischaemic stroke NOS
    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
    • To assess the efficacy of GSK249320 versus placebo on lower limb motor recovery, specifically locomotion, in ischemic stroke patients
    E.2.2Secondary objectives of the trial
    • To further demonstrate and characterize the extent and duration of overall motor recovery (i.e., locomotion, balance, number of falls, dexterity, strength and endurance) after treatment with GSK249320 or placebo in ischemic stroke patients
    • To evaluate the safety and tolerability of GSK249320 in comparison to placebo in ischemic stroke patients
    • To further characterize the immunogenicity profile of GSK249320 in ischemic stroke patients
    • To further characterize the pharmacokinetic (PK) profile of GSK249320 in ischemic stroke patients
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Have a confirmed diagnosis of stroke according to the World Health Organization definition which is, ‘a rapid onset event of vascular origin reflecting a focal disturbance of cerebral function, excluding isolated impairments of higher function, and persisting longer than 24 hours.
    2. Stroke onset must be within the last 24-72 hours. Time of stroke onset is defined as the time at which the patient/relative is first aware of the stroke deficit. For patients who awake with deficits, or who are found unconscious, the time of onset is defined as the time at which they were last known to be symptom free.
    3. Have a stroke that is radiologically confirmed to be ischemic and supratentorial. The diameter of the ischemic lesion is >15mm in any single direction or the volume is >4cc. See the Study Procedures Manual (SPM) for guidance on how to calculate the lesion size.
    4. Have a total NIHSS score of 3-21.
    5. Have a lower limb deficit from the incident stroke which is defined as a score of 1-4 on the NIHSS Motor Leg question (question #6).
    6. Aged 18-90, inclusive.
    7. Reasonable likelihood of receiving standard physical, occupational and speech rehabilitation therapy as indicated for the post stroke deficits.
    8. Reasonable likelihood of receiving both doses of Investigational Product.
    9. Male subjects and female subjects of non-child-bearing and child-bearing potential are allowed to participate in this study. See Section 11, Appendix 1 for definitions.
    Females of child-bearing potential must have a negative pregnancy test prior to enrollment and must agree to use one of the contraceptive methods specified in Section 11, Appendix 1.
    10. In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
    E.4Principal exclusion criteria
    1. Ability to walk >0.8m/s as measured by the Gait Velocity assessment.
    2. History of a previous symptomatic stroke within 3 months prior to study entry.
    3. Presence of significant disability prior to the current stroke. Significant disability is defined as having a pre-stroke Rankin score of >2.
    4. Subjects who are not alert or are unresponsive as defined by a score of 2 or 3 on the NIHSS Level of Consciousness question (Question 1a).
    5. Presence of significant aphasia likely to confound or interfere with completion of the study assessments.
    6. Presence of a significant pre-existing gait deficit prior to study entry that is likely to confound clinical evaluations
    7. Presence of pre-existing neurologic or psychiatric disease which is active and not adequately controlled such that it interfered with major activities of daily living immediately prior to the current stroke and is likely to interfere with study participation/visits or confound clinical evaluations.
    8. The subject poses a significant suicide risk, in the opinion of the investigator.
    9. Current or chronic history of liver disease, known hepatic or biliary abnormalities (except Gilbert’s syndrome or asymptomatic gallstones), or known history of hepatitis B or hepatitis C infection.
    10. Presence of either a central or peripheral demyelinating disease, such as multiple sclerosis or IgM monoclonal gammopathy of unknown significance (MGUS).
    11. Expected death due to the incident stroke, or evidence of a chronic co-morbid condition or unstable acute systemic illness which, in the opinion of the investigator, could shorten the subject’s survival such that it would limit his/her ability to complete the study.
    12. Presence of the following ECG values on baseline ECG: QTc > 500 msec; or uncorrected QT >600msec (machine or manual over-read).
    13. Participation in any investigational rehabilitation paradigm targeting stroke recovery during the duration of this study.
    14. The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
    15. Prior treatment with GSK249320.
    16. History of sensitivity to Investigational Product excipients that, in the opinion of the investigator or GSK Medical Monitor, contraindicates the subject's participation.
    17. Pregnant females as determined by positive urine hCG test prior to enrollment.
    18. Lactating females.
    19. Subjects considered unwilling or unable to comply with the procedures and study visit schedule outlined in the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy Endpoints:
    Mean change from baseline to Month 3/Day 90 in Gait Velocity

    .
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1, Month 1, 2, 3 and 6
    E.5.2Secondary end point(s)
    Secondary efficacy Endpoints:
    • Mean change from baseline to Month 6/Day 180 in Gait Velocity
    • Proportion of subjects transitioning from one category of gait velocity to the next higher category (0, >0 to < 0.4m/s, ≥0.4m/s to 0.8m/s, >0.8m/s)
    • Mean change from baseline to Month3/Day 90 and mean change from baseline to Month 6/Day 180 in:
    • Balance as measured by the Berg Balance total score
    • Dexterity as measured by Box and Blocks test (number of blocks transferred in 60 seconds)
    • Strength as measured by grip and knee extension dynamometry (kilograms and pounds, respectively)
    • Proportion of subjects experiencing falls and the number of falls between Baseline to Month 3/Day 90 and to Month 6/Day 180.
    • Mean change from Month 1/Day 30 to Month 3/Day 90 in endurance as measured by
    distance travelled in meters during the 2 Minute Walk Test.

    Safety Endpoints
    • Type and incidence of adverse events (AEs) and Events Common to Stroke (ECtS)
    • Change from baseline in vital signs (blood pressure and heart rate) and
    electrocardiogram (ECG) parameters
    • Change from baseline in chemistry and hematology safety labs
    • Change from baseline in the NIHSS
    • Prospective assessment of suicidality via Columbia Suicide Severity Rating Scale
    (C-SSRS)

    PK, PD Marker and Immunogenicity Endpoints:
    • The following PK parameters will be estimated, when feasible: Cmax, tmax, half
    life, AUC(0-), AUC(0-inf) clearance and volume of distribution. Age, gender, race, and weight will be tested as covariates on clearance and volume of distribution.
    • Selected PD assays of target engagement, will be performed. Other PD markers may be tested to further characterise the PD effects of GSK249320.
    • Antibodies against GSK249320 will be assessed using immunoelectrochemiluminescent (ECL) assays
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1, Month 1, 2, 3 and 6
    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 No
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    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
    Australia
    Belgium
    Canada
    Czech Republic
    Denmark
    France
    Germany
    Italy
    United Kingdom
    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
    LSLV
    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 months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 360
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 360
    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 No
    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
    Aphasia post stroke can prevent fully informed consent; therefore, consent can be obtained via subject’s legally authorized representative as per national and local guidelines. Subject should be re-consented when/if possible.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 145
    F.4.2.2In the whole clinical trial 360
    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)
    Investigational Product will not be made available for compassionate use for a subject after they are discharged from the study; however, at the end of this study, all subjects who received at least one dose of IP are eligible for participation in a separate study designed to evaluate and collect long term safety data, to at least one year post first dose of IP for a subject.
    The investigator is responsible for ensuring post study care of the patient’s medical condition.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation N/A
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-09-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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