NCT00298597

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2006

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

April 23, 2009

Status Verified

April 1, 2007

Enrollment Period

3 years

First QC Date

March 1, 2006

Last Update Submit

April 22, 2009

Conditions

Chronic StrokeAmyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (2)

  • Learning success in a word learning model

  • Response time in motor function tests

Secondary Outcomes (2)

  • Response time in a word learning model

  • Total time and number of keystrokes in motor function tests

Interventions

granulocyte - colony stimulating factor (G-CSF)DRUG
erythropoetin (EPO)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of chronic stroke or amyotrophic lateral sclerosis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of neurology, University Hospital of Muenster

Münster, North Rhine-Westphalia, D-48149, Germany

Location

Related Publications (5)

  • 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.

    PMID: 15236398BACKGROUND

  • 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.

    PMID: 16258290BACKGROUND

  • 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.

    PMID: 16007267BACKGROUND

  • 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.

    PMID: 21625426DERIVED

  • 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.

    PMID: 21423758DERIVED

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Granulocyte Colony-Stimulating FactorErythropoietin

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Wolf Rüdiger Schäbitz, MD

    Department of Neurology, University Hospital of Muenster, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 1, 2006

First Posted

March 2, 2006

Study Start

March 1, 2006

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

April 23, 2009

Record last verified: 2007-04

Locations

DE(1)