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

Purpose

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Influence of G-CSF and EPO on Associative Learning and Motor Skills

Resource links provided by NLM:

Genetics Home Reference related topics: amyotrophic lateral sclerosis

MedlinePlus related topics: Amyotrophic Lateral Sclerosis

Drug Information available for: Erythropoietin Epoetin Alfa Filgrastim Lenograstim Granulocyte colony-stimulating factor

U.S. FDA Resources

Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:

Learning success in a word learning model
Response time in motor function tests

Secondary Outcome Measures:

Response time in a word learning model
Total time and number of keystrokes in motor function tests

Estimated Enrollment:	180
Study Start Date:	March 2006
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00298597

Locations

Germany
Department of neurology, University Hospital of Muenster
Muenster, Nordrhein-Westfalen, Germany, D-48149

Sponsors and Collaborators

University Hospital Muenster

Investigators

Principal Investigator:

Wolf Rüdiger Schäbitz, MD

Department of Neurology, University Hospital of Muenster, Germany

More Information

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.

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. Epub 2005 Dec 27.

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 1;115(8):2083-2098. Epub 2005 Jul 7.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Floel A, Warnecke T, Duning T, Lating Y, Uhlenbrock J, Schneider A, Vogt G, Laage R, Koch W, Knecht S, Schäbitz WR. Granulocyte-colony stimulating factor (G-CSF) in stroke patients with concomitant vascular disease--a randomized controlled trial. PLoS One. 2011;6(5):e19767. Epub 2011 May 23.

Duning T, Schiffbauer H, Warnecke T, Mohammadi S, Floel A, Kolpatzik K, Kugel H, Schneider A, Knecht S, Deppe M, Schäbitz 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.

ClinicalTrials.gov Identifier:	NCT00298597 History of Changes
Other Study ID Numbers:	GCSFEPO_01, EudraCT Number 2005-001113-18
Study First Received:	March 1, 2006
Last Updated:	April 22, 2009
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Amyotrophic Lateral Sclerosis
Sclerosis
Stroke
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Pathologic Processes

Cerebrovascular Disorders
Brain Diseases
Vascular Diseases
Cardiovascular Diseases
Epoetin Alfa
Lenograstim
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013