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

NCT01227681 | Terminated Phase 2 Results DMC

• 1 other identifier: TCSP-01
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

high dose G-CSF

EXPERIMENTAL

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

Drug: G-CSF

low dose G-CSF

ACTIVE COMPARATOR

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

Drug: G-CSF

placebo

PLACEBO COMPARATOR

Sodium Chloride (NaCl) 0.9 %

Drug: Placebo

Interventions

G-CSF DRUG

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

Also known as: Filgrastim, Kirin, Japan

high dose G-CSF; low dose G-CSF

Placebo DRUG

Sodium Chloride (NaCl) 0.9 %

placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

Study Sites (1)

Buddhist Tzu Chi General Hospital

Hualien City, Taiwan

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Granulocyte Colony-Stimulating Factor; Filgrastim

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Dr. Chen Shin-Yuan
• Organization: Buddhist Tzu Chi General Hospital Hualien

william.sychen@msa.hinet.net

+886-3-8561825

Study Officials

• Shin Yuan Chen, MD

  Buddhist Tzu Chi General Hospital, Hualien

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2010
• First Posted: October 25, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 4, 2016
• Results First Posted: April 4, 2016

Record last verified: 2016-03

Locations

TW (1)