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Multicenter Efficacy Study of Recombinant Human Erythropoietin in Acute Ischemic Stroke (ESS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00604630
Recruitment Status : Completed
First Posted : January 30, 2008
Last Update Posted : October 22, 2008
Johnson & Johnson
Information provided by:
Max-Planck-Institute of Experimental Medicine

Brief Summary:
The purpose of this randomized, double-blind, placebo-controlled multicenter study is to determine in a cohort of 506 patients with acute ischemic stroke in the middle cerebral artery territory, the effect of a three-day high-dose, intravenous erythropoietin treatment on functional outcome up to a follow-up of 90 days.

Condition or disease Intervention/treatment Phase
Infarction, Middle Cerebral Artery Middle Cerebral Artery Stroke Stroke, Acute Drug: recombinant human erythropoietin alfa Drug: 0.9% NaCl Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 522 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: German Multicenter EPO Stroke Trial (Phase II/III)
Study Start Date : January 2003
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: placebo
50ml 0.9% NaCL
Drug: 0.9% NaCl
50ml 0.9% NaCl iv on 3 consecutive days, starting within 6 hours after onset of symptoms

Active Comparator: verum
erythropoietin alfa 40,000 IU iv in 50ml 0.9% NaCl
Drug: recombinant human erythropoietin alfa
40,000 IU in 50ml 0.9% NaCl iv on 3 consecutive days, starting within 6 hours after onset of symptoms
Other Name: ERYPO

Primary Outcome Measures :
  1. Neurological/functional outcome as measured by the Barthel Index (BI) [ Time Frame: day 90 ]

Secondary Outcome Measures :
  1. Modified Rankin Scale (mRS) responder [ Time Frame: day 90 ]
  2. Barthel Index (BI) [ Time Frame: day 30 ]
  3. mRS [ Time Frame: day30, day 90 ]
  4. NIH Stroke Scale [ Time Frame: day 1, 3, 7, 30, 90 ]
  5. Proportion of subjects with minimal disability (mRS 0-1) [ Time Frame: day 30, day 90 ]
  6. All-cause mortality [ Time Frame: day 90 ]
  7. Mortality directly related to stroke [ Time Frame: day 90 ]
  8. Proportion of subjects with BI >= 95 [ Time Frame: day 30, day 90 ]
  9. Proportion of subjects with BI=100 [ Time Frame: day 30, day 90 ]
  10. Proportion of subjects with neurological recovery [ Time Frame: day 3, 7, 30, 90 ]
  11. Distribution of mRS scores [ Time Frame: day 30, day 90 ]
  12. Distribution of BI scores [ Time Frame: day 30, day 90 ]
  13. Distribution of NIH Stroke Scale scores [ Time Frame: day 30, day 90 ]
  14. Serum level of glial damage markers S100B and GFAP [ Time Frame: day 1, 2, 3, 4, 7 ]
  15. Lesion size (MRI DWI, flair) [ Time Frame: day 1, day 7 ]
  16. Overall survival [ Time Frame: day 90 ]
  17. Late recovery index (BI day 90 versus BI day 30) [ Time Frame: day 30 to day 90 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ischemic stroke in the middle cerebral artery territory
  • Clearly defined time of onset
  • Confirmed by MRI (DWI, Flair)
  • NIH Stroke Scale ≥ 5
  • Age > 18 years
  • Treatment within 6h after onset of symptoms
  • Informed consent by patient, relatives or independent physician
  • Life expectancy > 90 days

Exclusion Criteria:

  • Coma or precoma (level of consciousness ≥ 2 in NIH Stroke Scale)
  • Previous stroke within the same territory
  • Intracranial or subarachnoidal hemorrhage
  • Traumatic brain injury or brain operation within the last 4 weeks
  • Neoplasia, septic embolism, infectious endocarditis
  • MRI contraindications
  • Renal failure (i.e. dependent on dialysis)
  • Known malignant/life-threatening disease
  • Known myeloproliferative disorder, polycythemia
  • Known allergy or antibodies against erythropoietin
  • Participation in other intervention trials
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00604630

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Neurologische Klinik des Städtischen Klinikums Braunschweig
Braunschweig, Germany, D-38126
Neurologische Klink, Klinikum Bremen-Mitte
Bremen, Germany, D-28177
Neurologische Klinik, Allgemeines Krankenhaus Celle
Celle, Germany, D-29223
Klinik und Poliklinik für Neurologie, Universitätsklinikum Carl Gustav Carus der TU Dresden
Dresden, Germany, D-01307
Neurologische Klinik, Universität Erlangen-Nürnberg
Erlangen, Germany, D-91054
Klinik für Neurologie, Universität Essen
Essen, Germany, D-45147
Neurologische Universitätsklinik der Georg-August-Universität Goettingen
Goettingen, Germany, D-37075
Neurologische Klinik, Medizinische Hochschule Hannover
Hannover, Germany, D-30625
Klinik und Poliklinik für Neurologie der Universität Leipzig
Leipzig, Germany, D-04103
Sponsors and Collaborators
Max-Planck-Institute of Experimental Medicine
Johnson & Johnson
Additional Information:

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Prof. Dr. Dr. Hannelore Ehrenreich (MD, DVM), Head of the Division of Clinical Neuroscience, Max-Planck-Institute of Experimental Medicine Identifier: NCT00604630    
Other Study ID Numbers: BfArM-4019639/2002
"EPO Stroke Study"
"Ehrenreich EPO Stroke Study"
"Ehrenreich Study"
First Posted: January 30, 2008    Key Record Dates
Last Update Posted: October 22, 2008
Last Verified: September 2008
Keywords provided by Max-Planck-Institute of Experimental Medicine:
stroke, middle cerebral artery
Ischemic stroke in the middle cerebral artery territory
Additional relevant MeSH terms:
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Infarction, Middle Cerebral Artery
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Cerebral Infarction
Brain Infarction
Brain Ischemia
Cerebral Arterial Diseases
Intracranial Arterial Diseases
Epoetin Alfa