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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier:
NCT01227681
First received: October 22, 2010
Last updated: January 3, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention Phase
Parkinson Disease
Drug: granulocyte colony stimulating factor
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Control, Study of the Neuro-protective Effect of Granulocyte-colony Stimulating Factor on Early Stage Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Buddhist Tzu Chi General Hospital:

Primary Outcome Measures:
  • motor performance on Unified Parkinson's Disease Rating Scale [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: June 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: high dose G-CSF
high dose group: 3.3ug/kg/day for consecutive 5 days of each 60 day cycle (6 cycles)
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 %

Other Name: 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: 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 %

Other Name: Filgrastim, Kirin, Japan
Placebo Comparator: placebo
Sodium Chloride (NaCl) 0.9 %
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 %

Other Name: Filgrastim, Kirin, Japan

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.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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,
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01227681

Locations
Taiwan
Buddhist Tzu Chi General Hospital
Hualien, Taiwan
Sponsors and Collaborators
Buddhist Tzu Chi General Hospital
Investigators
Principal Investigator: Shin Yuan Chen, MD Buddhist Tzu Chi General Hospital, Hualien
  More Information

No publications provided

Responsible Party: Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier: NCT01227681     History of Changes
Other Study ID Numbers: TCSP-01
Study First Received: October 22, 2010
Last Updated: January 3, 2013
Health Authority: Taiwan: Institutional Review Board

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014