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    Summary
    EudraCT Number:2011-000123-33
    Sponsor's Protocol Code Number:RH EPOA-REHAB
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-04-11
    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 ConcernedUK - MHRA
    A.2EudraCT number2011-000123-33
    A.3Full title of the trial
    Evaluation of the feasibility of modulating and measuring endogenous neurogenesis with erythropoietin (rhEPO╬▒) to expedite recovery after stroke
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The use of erythropoietin (rhEPOa) in patients with stroke to see if it can aid and speed up the recovery and regrowth of new nerve cells.
    A.3.2Name or abbreviated title of the trial where available
    Erythropoeitin to facilitate stroke recovery
    A.4.1Sponsor's protocol code numberRH EPOA-REHAB
    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 SponsorKing's College Hospital NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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 supportNational Institute of Health Research
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKing's College Hospital NHS Foundation Trust
    B.5.2Functional name of contact pointProfessor Lalit Kalra
    B.5.3 Address:
    B.5.3.1Street AddressClinical Neurosciences, Institute of Psychiatry
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE5 9PJ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00440203299 1718
    B.5.5Fax number00440203014 8891
    B.5.6E-maillalit.kalra@kcl.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorKing's College London
    B.1.3.4CountryUnited Kingdom
    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 supportNational Institute of Health Research
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKing's College London
    B.5.2Functional name of contact pointProfessor Lalit Kalra
    B.5.3 Address:
    B.5.3.1Street AddressClinical Neurosciences, Institute of Psychiatry
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE5 9PJ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00440203299 1718
    B.5.5Fax number00440203014 8891
    B.5.6E-maillalit.kalra@kcl.ac.uk
    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 EPREX 40,000 IU/ml, solution for injection in pre-filled syringe.
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameEPREX
    D.3.4Pharmaceutical form 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 INNEpoetin alpha
    D.3.9.1CAS number 113427-24-0
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40,000
    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 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
    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 10042244
    E.1.2Term Stroke
    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
    Does treatment with erythropoetin (EPO) during post acute rehabilitation of non-thrombolysed patients improve functional recovery in stroke patients?

    Can multimodal MR imaging be used for in vivo monitoring of brain repair in humans and do MRI parameters correlate with clinical measures of function recovery.
    E.2.2Secondary objectives of the trial
    Does treatment with EPO result in functional/structural restoration in the peri-infarct area that can be visualised using MRI techniques?

    What is the optimal timing of administration of EPO therapy to be effective?

    Is EPO treatment safe in non-thrombolysed stroke patients undergoing rehabilitation?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age 18-85 years, male and females

    Supratentorial ischaemic stroke, confirmed on imaging.

    Recruited within 48 hours of stroke onset. Time of onset is when symptoms began; for stroke that occurred during sleep, time of onset is when patient was last seen or was self-reported to be normal.

    Motor impairment of MRC grade <=4 affecting the upper or lower limb

    Reasonable expectation of availability to receive the full course of therapy, and to be available for subsequent follow-up visits.

    Reasonable expectation that patient will receive standard post-stroke physical, occupational and speech therapy as indicated.
    E.4Principal exclusion criteria
    • Pre-stroke modified Rankin Score (mRS) >2
    • Thrombolytic treatment with tPA following the index stroke.
    • Patients presenting with hemorrhagic and/or brain stem stroke.
    • Contraindications to MRI
    • Women who may be pregnant or breast-feeding.
    • Serum hemoglobin > 16 g/dL (males) or > 14 g/dL (females); or platelet count > 400,000/mm3.
    • Advanced liver, kidney, cardiac or pulmonary disease (serum bilirubin > 1.5 x upper limit of normal (ULN), Alkaline phosphatase > 2.5 x ULN, GGT>2.5xULN).
    • Serum creatinine >200 micromol/l
    • History of clotting disorders.
    • Expected survival < 1 year.
    • Hypersensitivity or other contraindication to erythropoeitin or to any of the excipients as per SPMC.
    • A known diagnosis of epilepsy
    • A known diagnosis of cancer (except non-malignant skin cancer).
    • Uncontrolled hypertension (BP persistently > 220 mm Hg systolic or 120 mm Hg diastolic despite antihypertensive therapy).
    • Pre-existing and active major psychiatric or other chronic neurological disease.
    • Currently participating in another investigational study.
    • Cognitive or communication problems that limit ability to provide informed consent or follow assessment procedures
    • Lack of capacity as defined by the Mental Capacity Act to provide informed consent
    E.5 End points
    E.5.1Primary end point(s)
    Fugl-Meyer scale score (Primary outcome measure)at 90 days
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 90 days after the onset of Stroke
    E.5.2Secondary end point(s)
    Measured at 30 and 90 days
    – NIHSS score
    – NIHSS score change from baseline
    – Fugl-Meyer scale score change from baseline
    – 10 metre timed walk test
    – Functional Independence Measure
    – Stroke Impact Scale
    – Modified Rankin Scale
    – Mortality

    Measured at 90 days:
    – FLAIR measurement of infarct volume
    – Diffusion Tensor Imaging Tractography of white matter tracts
    – Arterial Spin Labelling measurement of regional perfusion
    – Spectroscopy for N-acetylaspartate (NAA), Myoinositol, Choline and other stroke related metabolites
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 30 and 90 days after the onset of Stroke
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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
    Routine care/no intervention
    E.8.2.4Number of treatment arms in the trial3
    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 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
    At 3 months of follow up when all subjects have been recruited. No interim analyses are planned.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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.1.1Number 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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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
    By the very nature of the disease, some Stroke patients are unable to consent for themselves at the time of entry into the trial. In these circumstances consent will be obtained from a person responsible for the patient.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 90
    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)
    Treatment with erythropoeitin is required only on 3 occasions during rehabilitation; there is no need for continued treatment. Before the treatment can be offered in routine clinical practice, confirmation of benefit in Phase III studies is required.
    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 Decision2011-05-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-01
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-04-04
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