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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00604630
First Posted: January 30, 2008
Last Update Posted: October 22, 2008
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.
Collaborators:
Johnson & Johnson
Parexel
Information provided by:
Max-Planck-Institute of Experimental Medicine
January 17, 2008
January 30, 2008
October 22, 2008
January 2003
June 2008   (Final data collection date for primary outcome measure)
Neurological/functional outcome as measured by the Barthel Index (BI) [ Time Frame: day 90 ]
Same as current
Complete list of historical versions of study NCT00604630 on ClinicalTrials.gov Archive Site
  • Modified Rankin Scale (mRS) responder [ Time Frame: day 90 ]
  • Barthel Index (BI) [ Time Frame: day 30 ]
  • mRS [ Time Frame: day30, day 90 ]
  • NIH Stroke Scale [ Time Frame: day 1, 3, 7, 30, 90 ]
  • Proportion of subjects with minimal disability (mRS 0-1) [ Time Frame: day 30, day 90 ]
  • All-cause mortality [ Time Frame: day 90 ]
  • Mortality directly related to stroke [ Time Frame: day 90 ]
  • Proportion of subjects with BI >= 95 [ Time Frame: day 30, day 90 ]
  • Proportion of subjects with BI=100 [ Time Frame: day 30, day 90 ]
  • Proportion of subjects with neurological recovery [ Time Frame: day 3, 7, 30, 90 ]
  • Distribution of mRS scores [ Time Frame: day 30, day 90 ]
  • Distribution of BI scores [ Time Frame: day 30, day 90 ]
  • Distribution of NIH Stroke Scale scores [ Time Frame: day 30, day 90 ]
  • Serum level of glial damage markers S100B and GFAP [ Time Frame: day 1, 2, 3, 4, 7 ]
  • Lesion size (MRI DWI, flair) [ Time Frame: day 1, day 7 ]
  • Overall survival [ Time Frame: day 90 ]
  • Late recovery index (BI day 90 versus BI day 30) [ Time Frame: day 30 to day 90 ]
  • Modified Rankin Scale (mRS) responder [ Time Frame: day 90 ]
  • Barthel Index (BI) [ Time Frame: day 30 ]
  • mRS [ Time Frame: day30, day 90 ]
  • NIH Stroke Scale [ Time Frame: day 1, 3, 7, 30, 90 ]
  • Proportion of subjects with minimal disability (mRS 0-1) [ Time Frame: day 30, day 90 ]
  • All-cause mortality [ Time Frame: day 90 ]
  • Mortality directly related to stroke [ Time Frame: day 90 ]
  • Proportion of subjects with BI >= 95 [ Time Frame: day 30, day 90 ]
  • Proportion of subjects with BI=100 [ Time Frame: day 30, day 90 ]
  • Proportion of subjects with neurological recovery [ Time Frame: day 3, 7, 30, 90 ]
  • Distribution of mRS scores [ Time Frame: day 30, day 90 ]
  • Distribution of BI scores [ Time Frame: day 30, day 90 ]
  • Distribution of NIH Stroke Scale scores [ Time Frame: day 30, day 90 ]
  • Serum level of glial damage markers S100B and GFAP [ Time Frame: day 1, 2, 3, 4, 7 ]
  • Lesion size (MRI DWI, flair) [ Time Frame: day 1, day 7 ]
  • Overall survival [ Time Frame: day 90 ]
Not Provided
Not Provided
 
Multicenter Efficacy Study of Recombinant Human Erythropoietin in Acute Ischemic Stroke
German Multicenter EPO Stroke Trial (Phase II/III)
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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Infarction, Middle Cerebral Artery
  • Middle Cerebral Artery Stroke
  • Stroke, Acute
  • 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
  • Drug: 0.9% NaCl
    50ml 0.9% NaCl iv on 3 consecutive days, starting within 6 hours after onset of symptoms
  • Placebo Comparator: placebo
    50ml 0.9% NaCL
    Intervention: Drug: 0.9% NaCl
  • Active Comparator: verum
    erythropoietin alfa 40,000 IU iv in 50ml 0.9% NaCl
    Intervention: Drug: recombinant human erythropoietin alfa

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
522
June 2008
June 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00604630
BfArM-4019639/2002
"EPO Stroke Study"
"Ehrenreich EPO Stroke Study"
"Ehrenreich Study"
Yes
Not Provided
Not Provided
Prof. Dr. Dr. Hannelore Ehrenreich (MD, DVM), Head of the Division of Clinical Neuroscience, Max-Planck-Institute of Experimental Medicine
Max-Planck-Institute of Experimental Medicine
  • Johnson & Johnson
  • Parexel
Not Provided
Max-Planck-Institute of Experimental Medicine
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP