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

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

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

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

• Amyotrophic Lateral Sclerosis
• Chronic Stroke

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