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

This study has been completed.
Sponsor:
Information provided by:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00298597
First received: March 1, 2006
Last updated: April 22, 2009
Last verified: April 2007
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Central Nervous System Diseases
Metabolic Diseases
Motor Neuron Disease
Nervous System Diseases
Neurodegenerative Diseases
Neuromuscular Diseases
Proteostasis Deficiencies
Spinal Cord Diseases
TDP-43 Proteinopathies

ClinicalTrials.gov processed this record on October 20, 2014