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

A Double-Blind, Placebo-Control, Study of the Neuro-protective Effect of Granulocyte-colony Stimulating Factor on Early Stage Parkinson's Disease

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

Study Overview

• Status: Terminated
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: G-CSF; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Hualien, Taiwan
    • Buddhist Tzu Chi General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: high dose G-CSF; high dose group: 3.3ug/kg/day for consecutive 5 days of each 60 day cycle (6 cycles)	Drug: G-CSF; G-CSF(granulocyte-colony stimulating factor) is planned injected subcutaneously; Other Names: Filgrastim, Kirin, Japan
Active Comparator: low dose G-CSF; low dose group: 1.65ug/kg/day for consecutive 5 days of each 60 day cycle (6 cycles)	Drug: G-CSF; G-CSF(granulocyte-colony stimulating factor) is planned injected subcutaneously; Other Names: Filgrastim, Kirin, Japan
Placebo Comparator: placebo; Sodium Chloride (NaCl) 0.9 %	Drug: Placebo; Sodium Chloride (NaCl) 0.9 %

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Buddhist Tzu Chi General Hospital
• Investigators: Principal Investigator: Shin Yuan Chen, MD, Buddhist Tzu Chi General Hospital, Hualien

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: October 22, 2010
• First Submitted That Met QC Criteria: October 22, 2010
• First Posted (Estimate): October 25, 2010

Study Record Updates

• Last Update Posted (Estimate): April 4, 2016
• Last Update Submitted That Met QC Criteria: March 3, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: TCSP-01