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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01227681
• Other study ID #: TCSP-01
• Status: Active, not recruiting
• Phase: Phase 2
• First received: October 22, 2010
• Last updated: January 3, 2013
• Start date: June 2010
• Est. completion date: December 2013

Study information

• Verified date: January 2013
• Source: Buddhist Tzu Chi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• granulocyte colony stimulating factor
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 %

Locations

Country	Name	City	State
Taiwan	Buddhist Tzu Chi General Hospital	Hualien

Sponsors (1)

Lead Sponsor	Collaborator
Buddhist Tzu Chi General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	motor performance on Unified Parkinson's Disease Rating Scale		2 years	No