Influence of G-CSF and EPO on Associative Learning and Mo... | NCT00298597

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

NCT00298597

Sponsor

University Hospital Muenster

Status

Completed

Last Update Posted

Apr 23, 2009Estimated

Enrollment

180Estimated

Phase

Phase 2

Conditions

Chronic Stroke
Amyotrophic Lateral Sclerosis

Interventions

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

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT Number 2005-001113-18

Status Module

Record Verification Date

Apr 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2006

Primary Completion Date

Mar 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

Mar 1, 2006

First Submission Date that Met QC Criteria

Mar 1, 2006

First Posted Date

Mar 2, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2009

Last Update Posted Date

Apr 23, 2009Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Learning success in a word learning model
Response time in motor function tests

Secondary Outcomes

Measure	Description	Time Frame
Response time in a word learning model
Total time and number of keystrokes in motor function tests

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wolf Rüdiger Schäbitz, MD	Department of Neurology, University Hospital of Muenster, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of neurology, University Hospital of Muenster		Münster	North Rhine-Westphalia	D-48149	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15236398	Background	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.
16258290	Background	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.

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D016472	Motor Neuron Disease

ID	Term
D016179	Granulocyte Colony-Stimulating Factor
D004921	Erythropoietin

ID	Term
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates
D002241	Carbohydrates

Name	Type	Description	Arm Group Labels	Other Names
granulocyte - colony stimulating factor (G-CSF)	Drug
erythropoetin (EPO)	Drug