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Study of the Neuro-protective Effect of Granulocyte-colony Stimulating Factor on Early Stage Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Terminated
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
G-CSF
Placebo
Sponsored by
Buddhist Tzu Chi General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hoehn & Yahr stage I~III
  • Patients with idiopathic Parkinson's disease(PD), who meet the United Kingdom Parkinson's Disease Society Brain Bank diagnostic criteria, with a good response to levodopa
  • The onset of PD symptoms must be occurred > = 40 years of age (to exclude YOPD), and the patient must have been diagnosed with idiopathic PD > =40 years of age
  • Patients may have symptoms of wearing OFF and/or levodopa induced dyskinesia
  • Patients must rate between Hoehn & Yahr stage I to III, when in an OFF medication state
  • Patients must in their optimal medication treatment state, and will not changing their medications within 3 months before and after enrollment

Exclusion Criteria:

  • Patients who are proved to be Young Onset Parkinson's Disease (YOPD) and/or genetically related (e.g. Parkin).
  • Women of child-bearing potential, pregnant or lactating.
  • Patients who are proved to have tumor growth and/or malignancy.
  • Patients with a past (within one year) or present history of psychotic symptoms requiring anti- psychotic treatment.
  • Patients with active symptoms of major depression with suicidal ideation or suicide attempt.
  • Patients with previous brain surgery (including pallidotomy and deep brain stimulation).
  • Patients with significant cognitive impairment ( Mini-Mental State Examination, MMSE < 24).
  • Patients who do not sign the inform consent,

Sites / Locations

  • Buddhist Tzu Chi General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

high dose G-CSF

low dose G-CSF

placebo

Arm Description

high dose group: 3.3ug/kg/day for consecutive 5 days of each 60 day cycle (6 cycles)

low dose group: 1.65ug/kg/day for consecutive 5 days of each 60 day cycle (6 cycles)

Sodium Chloride (NaCl) 0.9 %

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 22, 2010
Last Updated
March 3, 2016
Sponsor
Buddhist Tzu Chi General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01227681
Brief Title
Study of the Neuro-protective Effect of Granulocyte-colony Stimulating Factor on Early Stage Parkinson's Disease
Official Title
A Double-Blind, Placebo-Control, Study of the Neuro-protective Effect of Granulocyte-colony Stimulating Factor on Early Stage Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
Difficulty in Recruitment
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Buddhist Tzu Chi General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effectiveness of neuroprotection from granulocyte colony-stimulating factor on Parkinson disease
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
high dose G-CSF
Arm Type
Experimental
Arm Description
high dose group: 3.3ug/kg/day for consecutive 5 days of each 60 day cycle (6 cycles)
Arm Title
low dose G-CSF
Arm Type
Active Comparator
Arm Description
low dose group: 1.65ug/kg/day for consecutive 5 days of each 60 day cycle (6 cycles)
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Sodium Chloride (NaCl) 0.9 %
Intervention Type
Drug
Intervention Name(s)
G-CSF
Other Intervention Name(s)
Filgrastim, Kirin, Japan
Intervention Description
G-CSF(granulocyte-colony stimulating factor) is planned injected subcutaneously
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Sodium Chloride (NaCl) 0.9 %
Primary Outcome Measure Information:
Title
Motor Performance of Unified Parkinson's Disease Rating Scale
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hoehn & Yahr stage I~III Patients with idiopathic Parkinson's disease(PD), who meet the United Kingdom Parkinson's Disease Society Brain Bank diagnostic criteria, with a good response to levodopa The onset of PD symptoms must be occurred > = 40 years of age (to exclude YOPD), and the patient must have been diagnosed with idiopathic PD > =40 years of age Patients may have symptoms of wearing OFF and/or levodopa induced dyskinesia Patients must rate between Hoehn & Yahr stage I to III, when in an OFF medication state Patients must in their optimal medication treatment state, and will not changing their medications within 3 months before and after enrollment Exclusion Criteria: Patients who are proved to be Young Onset Parkinson's Disease (YOPD) and/or genetically related (e.g. Parkin). Women of child-bearing potential, pregnant or lactating. Patients who are proved to have tumor growth and/or malignancy. Patients with a past (within one year) or present history of psychotic symptoms requiring anti- psychotic treatment. Patients with active symptoms of major depression with suicidal ideation or suicide attempt. Patients with previous brain surgery (including pallidotomy and deep brain stimulation). Patients with significant cognitive impairment ( Mini-Mental State Examination, MMSE < 24). Patients who do not sign the inform consent,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shin Yuan Chen, MD
Organizational Affiliation
Buddhist Tzu Chi General Hospital, Hualien
Official's Role
Principal Investigator
Facility Information:
Facility Name
Buddhist Tzu Chi General Hospital
City
Hualien
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

Study of the Neuro-protective Effect of Granulocyte-colony Stimulating Factor on Early Stage Parkinson's Disease

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