Influence of G-CSF and EPO on Associative Learning and Motor Skills

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: NCT00298597
Recruitment Status : Completed
First Posted : March 2, 2006
Last Update Posted : April 23, 2009
Information provided by:
University Hospital Muenster

Brief Summary:
In the study we want to prove whether the subcutaneous application of granulocyte-stimulating factor (G-CSF) and erythropoetin (EPO) influence associative learning and/or motor skills of patients, who suffer from chronic stroke or amyotrophic lateral sclerosis. The study hypothesis is that G-CSF and EPO improve associative learning and/or motor skills.

Condition or disease Intervention/treatment Phase
Chronic Stroke Amyotrophic Lateral Sclerosis Drug: granulocyte - colony stimulating factor (G-CSF) Drug: erythropoetin (EPO) Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Influence of G-CSF and EPO on Associative Learning and Motor Skills
Study Start Date : March 2006
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Primary Outcome Measures :
  1. Learning success in a word learning model
  2. Response time in motor function tests

Secondary Outcome Measures :
  1. Response time in a word learning model
  2. Total time and number of keystrokes in motor function tests

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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:

  • Diagnosis of chronic stroke or amyotrophic lateral sclerosis

Exclusion Criteria:

  • leucocytes > 10000/µl
  • hematocrit > 48%
  • thrombocytes < 150000/µl
  • severe rheumatoid arthritis
  • severe infection
  • severe liver or renal failure
  • severe arterial hypertension
  • recurrent thromboembolic events
  • severe coronary heart disease
  • myocardial infarction
  • malignant tumor
  • leukemia
  • peripheral arterial occlusion disease

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): NCT00298597

Department of neurology, University Hospital of Muenster
Muenster, Nordrhein-Westfalen, Germany, D-48149
Sponsors and Collaborators
University Hospital Muenster
Principal Investigator: Wolf Rüdiger Schäbitz, MD Department of Neurology, University Hospital of Muenster, Germany

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00298597     History of Changes
Other Study ID Numbers: GCSFEPO_01
EudraCT Number 2005-001113-18
First Posted: March 2, 2006    Key Record Dates
Last Update Posted: April 23, 2009
Last Verified: April 2007

Additional relevant MeSH terms:
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Epoetin Alfa