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

This study has been completed.
Sponsor:
Collaborators:
Johnson & Johnson
Parexel
Information provided by:
Max-Planck-Institute of Experimental Medicine
ClinicalTrials.gov Identifier:
NCT00604630
First received: January 17, 2008
Last updated: October 21, 2008
Last verified: September 2008
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: German Multicenter EPO Stroke Trial (Phase II/III)

Resource links provided by NLM:


Further study details as provided by Max-Planck-Institute of Experimental Medicine:

Primary Outcome Measures:
  • Neurological/functional outcome as measured by the Barthel Index (BI) [ Time Frame: day 90 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Modified Rankin Scale (mRS) responder [ Time Frame: day 90 ] [ Designated as safety issue: No ]
  • Barthel Index (BI) [ Time Frame: day 30 ] [ Designated as safety issue: No ]
  • mRS [ Time Frame: day30, day 90 ] [ Designated as safety issue: No ]
  • NIH Stroke Scale [ Time Frame: day 1, 3, 7, 30, 90 ] [ Designated as safety issue: No ]
  • Proportion of subjects with minimal disability (mRS 0-1) [ Time Frame: day 30, day 90 ] [ Designated as safety issue: No ]
  • All-cause mortality [ Time Frame: day 90 ] [ Designated as safety issue: Yes ]
  • Mortality directly related to stroke [ Time Frame: day 90 ] [ Designated as safety issue: Yes ]
  • Proportion of subjects with BI >= 95 [ Time Frame: day 30, day 90 ] [ Designated as safety issue: No ]
  • Proportion of subjects with BI=100 [ Time Frame: day 30, day 90 ] [ Designated as safety issue: No ]
  • Proportion of subjects with neurological recovery [ Time Frame: day 3, 7, 30, 90 ] [ Designated as safety issue: No ]
  • Distribution of mRS scores [ Time Frame: day 30, day 90 ] [ Designated as safety issue: No ]
  • Distribution of BI scores [ Time Frame: day 30, day 90 ] [ Designated as safety issue: No ]
  • Distribution of NIH Stroke Scale scores [ Time Frame: day 30, day 90 ] [ Designated as safety issue: No ]
  • Serum level of glial damage markers S100B and GFAP [ Time Frame: day 1, 2, 3, 4, 7 ] [ Designated as safety issue: No ]
  • Lesion size (MRI DWI, flair) [ Time Frame: day 1, day 7 ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: day 90 ] [ Designated as safety issue: Yes ]
  • Late recovery index (BI day 90 versus BI day 30) [ Time Frame: day 30 to day 90 ] [ Designated as safety issue: No ]

Enrollment: 522
Study Start Date: January 2003
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604630

Locations
Germany
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
Parexel
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Dr. Hannelore Ehrenreich (MD, DVM), Head of the Division of Clinical Neuroscience, Max-Planck-Institute of Experimental Medicine
ClinicalTrials.gov Identifier: NCT00604630     History of Changes
Other Study ID Numbers: BfArM-4019639/2002, "EPO Stroke Study", "Ehrenreich EPO Stroke Study", "Ehrenreich Study"
Study First Received: January 17, 2008
Last Updated: October 21, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Max-Planck-Institute of Experimental Medicine:
stroke
EPO
erythropoietin
ischemia
hypoxia
antiapoptosis
neuroprotection
rtPA
thrombolysis
stroke, middle cerebral artery
Ischemic stroke in the middle cerebral artery territory

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Infarction
Infarction, Middle Cerebral Artery
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Ischemia
Pathologic Processes
Necrosis
Cerebral Arterial Diseases
Intracranial Arterial Diseases
Epoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014