- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00298597
Influence of G-CSF and EPO on Associative Learning and Motor Skills
April 22, 2009 updated by: University Hospital Muenster
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
180
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nordrhein-Westfalen
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Muenster, Nordrhein-Westfalen, Germany, D-48149
- Department of neurology, University Hospital of Muenster
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Learning success in a word learning model
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Response time in motor function tests
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Secondary Outcome Measures
Outcome Measure |
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Response time in a word learning model
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Total time and number of keystrokes in motor function tests
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wolf Rüdiger Schäbitz, MD, Department of Neurology, University Hospital of Muenster, Germany
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Knecht S, Breitenstein C, Bushuven S, Wailke S, Kamping S, Floel A, Zwitserlood P, Ringelstein EB. Levodopa: faster and better word learning in normal humans. Ann Neurol. 2004 Jul;56(1):20-6. doi: 10.1002/ana.20125.
- Schneider A, Kruger C, Steigleder T, Weber D, Pitzer C, Laage R, Aronowski J, Maurer MH, Gassler N, Mier W, Hasselblatt M, Kollmar R, Schwab S, Sommer C, Bach A, Kuhn HG, Schabitz WR. The hematopoietic factor G-CSF is a neuronal ligand that counteracts programmed cell death and drives neurogenesis. J Clin Invest. 2005 Aug;115(8):2083-98. doi: 10.1172/JCI23559. Epub 2005 Jul 7.
- Schneider A, Kuhn HG, Schabitz WR. A role for G-CSF (granulocyte-colony stimulating factor) in the central nervous system. Cell Cycle. 2005 Dec;4(12):1753-7. doi: 10.4161/cc.4.12.2213. Epub 2005 Dec 27.
- Floel A, Warnecke T, Duning T, Lating Y, Uhlenbrock J, Schneider A, Vogt G, Laage R, Koch W, Knecht S, Schabitz WR. Granulocyte-colony stimulating factor (G-CSF) in stroke patients with concomitant vascular disease--a randomized controlled trial. PLoS One. 2011;6(5):e19767. doi: 10.1371/journal.pone.0019767. Epub 2011 May 23.
- Duning T, Schiffbauer H, Warnecke T, Mohammadi S, Floel A, Kolpatzik K, Kugel H, Schneider A, Knecht S, Deppe M, Schabitz WR. G-CSF prevents the progression of structural disintegration of white matter tracts in amyotrophic lateral sclerosis: a pilot trial. PLoS One. 2011 Mar 14;6(3):e17770. doi: 10.1371/journal.pone.0017770.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
March 1, 2006
First Submitted That Met QC Criteria
March 1, 2006
First Posted (Estimate)
March 2, 2006
Study Record Updates
Last Update Posted (Estimate)
April 23, 2009
Last Update Submitted That Met QC Criteria
April 22, 2009
Last Verified
April 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCSFEPO_01
- EudraCT Number 2005-001113-18
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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