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

• Status: Terminated
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Buddhist Tzu Chi General Hospital
• Treatments: Lenograstim; Neuroprotective Agents

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,