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.

Evaluation of the feasibility of modulating and measuring endogenous neurogenesis with erythropoietin (rhEPOa) to expedite recovery after stroke - Erythropoeitin to facilitate stroke recovery

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000123-33-GB

Enrollment

Registered

2011-04-11

Start date

2011-06-01

Completion date

Unknown

Last updated

2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke MedDRA version: 14.0 Level: LLT Classification code 10042244 Term: Stroke System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: EPREX 40,000 IU/ml, solution for injection in pre-filled syringe. Product Name: EPREX Pharmaceutical Form: Solution for injection INN or Proposed INN: Epoetin alpha CAS Number: 113427-24-

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range 90

Exclusion criteria

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 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

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: 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? ;Primary end point(s): Fugl-Meyer scale score (Primary outcome measure)at 90 days;Timepoint(s) of evaluation of this end point: At 90 days after the onset of Stroke	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: 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? ;Primary end point(s): Fugl-Meyer scale score (Primary outcome measure)at 90 days;Timepoint(s) of evaluation of this end point: At 90 days after the onset of Stroke

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Secondary

Measure	Time frame
Secondary 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 ;Timepoint(s) of evaluation of this end point: At 30 and 90 days after the onset of Stroke	—

Measure

Time frame

Secondary 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 ;Timepoint(s) of evaluation of this end point: At 30 and 90 days after the onset of Stroke

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Countries

United Kingdom

Contacts

Public ContactProfessor Lalit Kalra

King's College Hospital NHS Foundation Trust

lalit.kalra@kcl.ac.uk00440203299 1718

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026