Chronic StrokePhase 2NCT00298597
Influence of G-CSF and EPO on Associative Learning and Motor Skills
A Phase 2 study testing granulocyte - colony stimulating factor (G-CSF) and erythropoetin (EPO) in people with Chronic Stroke and Amyotrophic Lateral Sclerosis, run by University Hospital Muenster at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Stroke, Amyotrophic Lateral Sclerosis
- What is being tested?
- granulocyte - colony stimulating factor (G-CSF) and erythropoetin (EPO)
- How many people
- 180 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2006to Mar 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of chronic stroke or amyotrophic lateral sclerosis
Who cannot join
- leucocytes > 10000/µl
- hematocrit > 48%
- thrombocytes < 150000/µl
- severe rheumatoid arthritis
- severe infection
- severe liver or renal failure
Show all 13Show fewer
- severe arterial hypertension
- recurrent thromboembolic events
- severe coronary heart disease
- myocardial infarction
- malignant tumor
- leukemia
- peripheral arterial occlusion disease
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of neurology, University Hospital of Muenster
Münster, North Rhine-Westphalia, D-48149
About this study
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.
- Conditions
- Chronic Stroke, Amyotrophic Lateral Sclerosis
- Being tested
- granulocyte - colony stimulating factor (G-CSF), erythropoetin (EPO)
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
granulocyte - colony stimulating factor (G-CSF)Drug
erythropoetin (EPO)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Investigators
- Wolf Rüdiger Schäbitz, MD, Principal investigator, Department of Neurology, University Hospital of Muenster, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00298597
- Sponsor's protocol ID
- GCSFEPO_01
- Other IDs
- EudraCT Number 2005-001113-18
- Status last verified
- Apr 2007
- First submitted
- 1 Mar 2006
- Last updated
- 23 Apr 2009
- Results posted
- No
Publications
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.
PubMed 15236398Schneider 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.
PubMed 16258290Schneider 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.
PubMed 16007267Floel 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.
PubMed 21625426Duning 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.
PubMed 21423758
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of G-CSF and EPO on Associative Learning and Motor Skills
- ClinicalTrials.gov ID
- NCT00298597
- Acronym / sponsor ID
- GCSFEPO_01
- Conditions
- Chronic Stroke, Amyotrophic Lateral Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 2 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of chronic stroke or amyotrophic lateral sclerosis
Key exclusion criteria (13 listed)
- leucocytes > 10000/µl
- hematocrit > 48%
- thrombocytes < 150000/µl
- severe rheumatoid arthritis
- severe infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| granulocyte - colony stimulating factor (G-CSF) | Drug | – |
| erythropoetin (EPO) | Drug | – |
Primary outcome
Learning success in a word learning model
Response time in motor function tests
2 secondary outcomes
Response time in a word learning model
Total time and number of keystrokes in motor function tests
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2009.
- Background: PubMed 15236398Knecht 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.
- Background: PubMed 16258290Schneider 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.
- Background: PubMed 16007267Schneider 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.
- Derived from this study: PubMed 21625426Floel 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.
- Derived from this study: PubMed 21423758Duning 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.
Related trials for Chronic Stroke
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Recruiting
Hand and Arm Motor Recovery Via Non-invasive Electrical Spinal Cord Stimulation After Stroke
Stroke, Ischemic, Chronic Stroke
RecruitingPhase 3
A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)
Atherosclerosis Cardiovascular Disease, Chronic Kidney Disease
Not yet recruiting
Proof-of-concept for Use of Transcutaneous Spinal Stimulation (TSS) With the ExaStim® Stimulation System in Adults With Chronic Ischemic Stroke
Chronic Stroke, Ischemic Stroke
Recruiting
Task-Oriented Training Versus High-Intensity Gait Training in People With Chronic Stroke
Stroke, Hemiplegia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolf Rüdiger Schäbitz, MD principal investigator
Department of Neurology, University Hospital of Muenster, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing granulocyte - colony stimulating factor (G-CSF) and erythropoetin (EPO) in people with Chronic Stroke and Amyotrophic Lateral Sclerosis, run by University Hospital Muenster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Learning success in a word learning model. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00298597, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2009.