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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00298597
Other study ID # GCSFEPO_01
Secondary ID EudraCT Number 2
Status Completed
Phase Phase 2
First received March 1, 2006
Last updated April 22, 2009
Start date March 2006
Est. completion date March 2009

Study information

Verified date April 2007
Source University Hospital Muenster
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date March 2009
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
granulocyte - colony stimulating factor (G-CSF)

erythropoetin (EPO)


Locations

Country Name City State
Germany Department of neurology, University Hospital of Muenster Muenster Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Knecht S, Breitenstein C, Bushuven S, Wailke S, Kamping S, Flöel A, Zwitserlood P, Ringelstein EB. Levodopa: faster and better word learning in normal humans. Ann Neurol. 2004 Jul;56(1):20-6. — View Citation

Schneider A, Krüger 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, Schäbitz 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. Epub 2005 Jul 7. — View Citation

Schneider A, Kuhn HG, Schäbitz 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Learning success in a word learning model
Primary Response time in motor function tests
Secondary Response time in a word learning model
Secondary Total time and number of keystrokes in motor function tests
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