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

NCT ID: NCT00298597

Last Updated: 2009-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2009-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Stroke Amyotrophic Lateral Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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granulocyte - colony stimulating factor (G-CSF)

Intervention Type DRUG

erythropoetin (EPO)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Muenster

OTHER

Sponsor Role lead

Principal Investigators

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Wolf Rüdiger Schäbitz, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, University Hospital of Muenster, Germany

Locations

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Department of neurology, University Hospital of Muenster

Münster, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 15236398 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16258290 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16007267 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21625426 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21423758 (View on PubMed)

Other Identifiers

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EudraCT Number 2005-001113-18

Identifier Type: -

Identifier Source: secondary_id

GCSFEPO_01

Identifier Type: -

Identifier Source: org_study_id

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