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

Phase 2

Terminated

• Conditions: Parkinson Disease
• Interventions: Drug: Placebo; Drug: G-CSF

• Registration Number: NCT01227681
• Lead Sponsor: Buddhist Tzu Chi General Hospital

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.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-10-22
• Study First Submitted QC: 2010-10-22
• Study First Posted: 2010-10-25
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Results First Submitted: 2014-07-17
• Status Verified: 2016-03
• Results First Submitted QC: 2016-03-03
• Last Update Submitted: 2016-03-03
• Results First Posted: 2016-04-04
• Last Update Posted: 2016-04-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	Sodium Chloride (NaCl) 0.9 %
high dose G-CSF	G-CSF	high dose group: 3.3ug/kg/day for consecutive 5 days of each 60 day cycle (6 cycles)
low dose G-CSF	G-CSF	low dose group: 1.65ug/kg/day for consecutive 5 days of each 60 day cycle (6 cycles)

Primary Outcome Measures

Name	Time	Method
Motor Performance of Unified Parkinson's Disease Rating Scale	2 years	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.

Trial Locations

Locations (1)

Buddhist Tzu Chi General Hospital; 🇨🇳 Hualien, Taiwan