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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

January 17, 2008
October 21, 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 ] [ Designated as safety issue: No ]
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 ] [ 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 ]
  • 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 ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Both
18 Years and older
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
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