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    Clinical Trial Results:
    Evaluation of the feasibility of modulating and measuring endogenous neurogenesis with erythropoietin (rhEPOα) to expedite recovery after stroke

    Summary
    EudraCT number
    		 2011-000123-33
    Trial protocol
    		 GB  
    Global end of trial date
    04 Apr 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Oct 2018
    First version publication date
    26 Oct 2018
    Other versions
    Summary report(s)
    		 FINAL STUDY REPORT

    Trial information

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    Trial identification
    Sponsor protocol code
    RH EPOA-REHAB
    Additional study identifiers
    ISRCTN number
    		 ISRCTN50896492
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    King's College Hospital
    Sponsor organisation address
    Denmark Hill, London, United Kingdom, SE5 9RS
    Public contact
    Professor Lalit Kalra, King's College Hospital NHS Foundation Trust, 0044 0203299 1718, lalit.kalra@kcl.ac.uk
    Scientific contact
    Professor Lalit Kalra, King's College Hospital NHS Foundation Trust, 0044 0203299 1718, lalit.kalra@kcl.ac.uk
    Sponsor organisation name
    King's College London
    Sponsor organisation address
    The Strand, London, United Kingdom, WC2R 2LS
    Public contact
    Professor Lalit Kalra, King's College London, 0044 0203299 1718, lalit.kalra@kcl.ac.uk
    Scientific contact
    Professor Lalit Kalra, King's College London, 0044 0203299 1718, lalit.kalra@kcl.ac.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Jul 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Sep 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Apr 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main 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.
    Protection of trial subjects
    The Data Monitoring Committee will review safety data, incidence of new thrombotic events and any cases where the Hb rises above the normal range. The data will be reviewed afte r10 patients have been recruited into each of the treatment arms, or 6 monthly intervals, whichever is sooner.
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    13 Nov 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 12
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    8
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 12 subjects were recruited however only 10 were eligible after baseline and only 3 subjects completed the protocol visits.

    Pre-assignment
    Screening details
    		 Baseline Assessment Within 48 Hours of Onset of Stroke The following information will be collected prior to randomisation: - Consent – Medical history, stroke characteristics, vascular risk profile – National Institute of Health Stroke Scale (NIHSS) score – BP, temperature, heart rate – Haemogram, renal and liver function tests – CT findings

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Full study
    Arm description
    		 The research design was to investigate 3 groups of 30 stroke patients each who were within 48 hours of stroke onset, had not been thrombolysed and had no contraindications to rhEPOα treatment. All groups received the best usual treatment consisting of structured multidisciplinary rehabilitation on a stroke unit. In addition, participants in the second group received rh EPOα alfa (Eprex) 40,000 IU given intravenously at 1, 3 and 5 days and those in the third group will receive rh EPOα 40,000 IU/ given intravenously at 7, 14, 21 days. The differences in recovery between the groups was assessed at 30 and 90 days after randomisation by measuring clinical recovery in function and changes in the brain perfusion and structure using magnetic resonance (MR) imaging.
    Arm type
    		 Experimental

    Investigational medicinal product name
    EPREX 40,000 IU/ml, solution for injection in pre-filled syringe
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Each patient will receive epoetin alfa (EPREX) 40,000 IU given intravenously over 5-10 minutes at 1, 3 and 5 days or 7, 14 and 21 days post randomization.

    Number of subjects in period 1
    		Full study
    Started
    12
    Completed
    3
    Not completed
    9
         Consent withdrawn by subject
    7
         ineligable
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 12 12
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 8 8
        From 65-84 years
    		 4 4
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 5 5
        Male
    		 7 7

    End points

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    End points reporting groups
    Reporting group title
    Full study
    Reporting group description
    		 The research design was to investigate 3 groups of 30 stroke patients each who were within 48 hours of stroke onset, had not been thrombolysed and had no contraindications to rhEPOα treatment. All groups received the best usual treatment consisting of structured multidisciplinary rehabilitation on a stroke unit. In addition, participants in the second group received rh EPOα alfa (Eprex) 40,000 IU given intravenously at 1, 3 and 5 days and those in the third group will receive rh EPOα 40,000 IU/ given intravenously at 7, 14, 21 days. The differences in recovery between the groups was assessed at 30 and 90 days after randomisation by measuring clinical recovery in function and changes in the brain perfusion and structure using magnetic resonance (MR) imaging.

    Primary: Clinical Endpoint

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    End point title
    		 Clinical Endpoint [1]
    End point description
    – Fugl-Meyer scale score – Fugl-Meyer scale score change from baseline
    End point type
    Primary
    End point timeframe
    Clinical outcome measures will be assessed at baseline, 30 ± 5 days and 90 ±10 days after randomisation.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The findings would not be significant as the number of participants at the close of the study was well below the numbers needed to be statistically significant. Only 3 participants completed the trial.
    End point values
    		 Full study
    Number of subjects analysed
    3
    Units: whole
    3
    Attachments
    		 EPO-REHAB tables
    No statistical analyses for this end point

    Secondary: Clinical Endpoint

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    End point title
    		 Clinical Endpoint
    End point description
    Secondary clinical outcome measures were the NIHSS score, Functional Independence Measure (FIM), FIM Motor score, Modified Rankin score (MRS) and Mortality
    End point type
    Secondary
    End point timeframe
    Baseline and 30 days post dose.
    End point values
    		 Full study
    Number of subjects analysed
    3
    Units: whole
    3
    No statistical analyses for this end point

    Secondary: Imaging

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    End point title
    		 Imaging
    End point description
    Evaluate whether MRI techniques can be used for in vivo imaging of brain repair in humans and correlate MRI parameters with clinical measures of function recovery
    End point type
    Secondary
    End point timeframe
    90 days post dose
    End point values
    		 Full study
    Number of subjects analysed
    3
    Units: whole
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Throughout the trial.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Whole Trial
    Reporting group description
    		 -

    Serious adverse events
    		 Whole Trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Whole Trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No adverse events were recorded due to the very small final dataset.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Aug 2011
    Changes to MHRA-approved protocol , including inclusion/exclusion, following REC review

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The findings would not be significant as the number of participants at the close of the study was well below the numbers needed to be statistically significant. Only 3 participants completed the trial.
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    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.

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