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.

• Register: EUCTR
• Last refreshed on: 2 October 2017
• Main ID: EUCTR2011-000123-33-GB
• Date of registration: 11/04/2011
• Prospective Registration: Yes
• Primary sponsor: King's College Hospital NHS Foundation Trust
• Public title: 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.
• Scientific title: Evaluation of the feasibility of modulating and measuring endogenous neurogenesis with erythropoietin (rhEPOa) to expedite recovery after stroke - Erythropoeitin to facilitate stroke recovery
• Date of first enrolment: 01/06/2011
• Target sample size: 90
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-000123-33
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Routine care/no intervention Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

United Kingdom

Contacts

• Name: Professor Lalit Kalra
• Affiliation: King's College Hospital NHS Foundation Trust

• Name: Professor Lalit Kalra
• Affiliation: King's College Hospital NHS Foundation Trust

Key inclusion & exclusion 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 <=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.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

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: 113427-24-0
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 40,000-

Primary Outcome(s)

Primary end point(s): Fugl-Meyer scale score (Primary outcome measure)at 90 days

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?

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

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 Outcome(s)

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

Secondary ID(s)

RH EPOA-REHAB

Source(s) of Monetary Support

National Institute of Health Research

Secondary Sponsor(s)

King's College London