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Difficulty in Recruitment
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The purpose of this study is to evaluate the effectiveness of neuroprotection from granulocyte colony-stimulating factor on Parkinson disease
Parkinson's disease (PD) is the second most common neurodegenerative disease and the severity of PD still progress during the ensuing years. Currently, there is no promising medical or surgical treatment to abrogate the disease deterioration. Granulocyte colony-stimulating factor (G-CSF), one of hematopoietic growth factors, has been routinely used for hematologic disorders and stem cell harvest from normal subject. G-CSF also demonstrated neuroprotection for rodents PD model. We hypothesize G-CSF will exert the effectiveness of neuroprotection for PD patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high dose G-CSF | Experimental | high dose group: 3.3ug/kg/day for consecutive 5 days of each 60 day cycle (6 cycles) |
|
| low dose G-CSF | Active Comparator | low dose group: 1.65ug/kg/day for consecutive 5 days of each 60 day cycle (6 cycles) |
|
| placebo | Placebo Comparator | Sodium Chloride (NaCl) 0.9 % |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G-CSF | Drug | G-CSF(granulocyte-colony stimulating factor) is planned injected subcutaneously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Motor Performance of Unified Parkinson's Disease Rating Scale | To assess Unified Parkinson's Disease Rating Scale part III (motor function) scores from baseline Medication-off status to Medication-off status after G-CSF injection one year. Scores of UPDRS Part III ranges from 0 to 108 and higher values indicate worse outcome. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shin Yuan Chen, MD | Buddhist Tzu Chi General Hospital, Hualien | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buddhist Tzu Chi General Hospital | Hualien City | Taiwan |
No participants were randomized to receive 1.65ug/kg/day of G-CSF and placebo
Parkinson's disease research center, Tzu Chi Hospital
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| ID | Title | Description |
|---|---|---|
| FG000 | G-CSF | 3.3ug/kg/day for consecutive 5 days of each 60 day cycle |
| FG001 | Low Dose G-CSF | 1.65ug/kg/day for consecutive 5 days of each 60 day cycle |
| FG002 | Placebo | subcutaneous Normal saline for consecutive 5 days of each 60 day cycle |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High Dose G-CSF Injection for Parkinson's Disease | 3.3 ug/kg/day for consecutive 5 days of each 60 day cycle |
| BG001 | Low Dose G-CSF Injection for Parkinson's Disease | 1.65 ug/kg/day for consecutive 5 days of each 60 day cycle |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Motor Performance of Unified Parkinson's Disease Rating Scale | To assess Unified Parkinson's Disease Rating Scale part III (motor function) scores from baseline Medication-off status to Medication-off status after G-CSF injection one year. Scores of UPDRS Part III ranges from 0 to 108 and higher values indicate worse outcome. | Posted | Mean | Full Range | scores on a scale | 2 years |
|
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | G-CSF Injection for Parkinson's Disease | 3.3ug/kg/day for consecutive 5 days of each 60 day cycle |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculo-skeletal soreness | Musculoskeletal and connective tissue disorders | Systematic Assessment | 3/4 participants had soreness during 5 days G-CSF injection period and discomfort can be mitigated by NSAID or Acetaminophen |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Chen Shin-Yuan | Buddhist Tzu Chi General Hospital Hualien | +886-3-8561825 | 2151 | william.sychen@msa.hinet.net |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D000069585 | Filgrastim |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| Placebo | Drug | Sodium Chloride (NaCl) 0.9 % |
|
| BG002 | Placebo | normal saline 0.9% injection |
| BG003 | Total | Total of all reporting groups |
| participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Gender | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 4 |
| 3 |
| 4 |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |