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

NCT ID: NCT01227681

Last Updated: 2016-04-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2013-12-31

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

high dose G-CSF

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

Group Type: EXPERIMENTAL

G-CSF

Intervention Type: DRUG

G-CSF(granulocyte-colony stimulating factor) is planned injected subcutaneously

low dose G-CSF

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

Group Type: ACTIVE_COMPARATOR

G-CSF

Intervention Type: DRUG

G-CSF(granulocyte-colony stimulating factor) is planned injected subcutaneously

placebo

Sodium Chloride (NaCl) 0.9 %

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Sodium Chloride (NaCl) 0.9 %

Interventions

G-CSF

G-CSF(granulocyte-colony stimulating factor) is planned injected subcutaneously

Intervention Type: DRUG

Placebo

Sodium Chloride (NaCl) 0.9 %

Intervention Type: DRUG

Other Intervention Names

Filgrastim, Kirin, Japan

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,

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Buddhist Tzu Chi General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shin Yuan Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Buddhist Tzu Chi General Hospital, Hualien

Locations

Buddhist Tzu Chi General Hospital

Hualien City, , Taiwan

Countries

Taiwan

Other Identifiers

TCSP-01

Identifier Type: -

Identifier Source: org_study_id