Status:
TERMINATED
Study of the Neuro-protective Effect of Granulocyte-colony Stimulating Factor on Early Stage Parkinson's Disease
Lead Sponsor:
Buddhist Tzu Chi General Hospital
Conditions:
Parkinson Disease
Eligibility:
All Genders
40-65 years
Phase:
PHASE2
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 treatm...
Eligibility Criteria
Inclusion
- 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
- 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,
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01227681
Start Date
June 1 2010
End Date
December 1 2013
Last Update
April 4 2016
Active Locations (1)
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1
Buddhist Tzu Chi General Hospital
Hualien City, Taiwan