Overview

This trial is active, not recruiting.

Condition parkinson disease
Treatment granulocyte colony stimulating factor
Phase phase 2
Sponsor Buddhist Tzu Chi General Hospital
Start date June 2010
End date December 2013
Trial size 36 participants
Trial identifier NCT01227681, TCSP-01

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
high dose group: 3.3ug/kg/day for consecutive 5 days of each 60 day cycle (6 cycles)
granulocyte colony stimulating factor Filgrastim, Kirin, Japan
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) placebo: Sodium Chloride (NaCl) 0.9 %
(Active Comparator)
low dose group: 1.65ug/kg/day for consecutive 5 days of each 60 day cycle (6 cycles)
granulocyte colony stimulating factor Filgrastim, Kirin, Japan
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) placebo: Sodium Chloride (NaCl) 0.9 %
(Placebo Comparator)
Sodium Chloride (NaCl) 0.9 %
granulocyte colony stimulating factor Filgrastim, Kirin, Japan
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) placebo: Sodium Chloride (NaCl) 0.9 %

Primary Outcomes

Measure
motor performance on Unified Parkinson's Disease Rating Scale
time frame: 2 years

Eligibility Criteria

Male or female participants from 40 years up to 65 years old.

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,

Additional Information

Official title A Double-Blind, Placebo-Control, Study of the Neuro-protective Effect of Granulocyte-colony Stimulating Factor on Early Stage Parkinson's Disease
Principal investigator Shin Yuan Chen, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by Buddhist Tzu Chi General Hospital.