Trial Outcomes & Findings for Study of the Neuro-protective Effect of Granulocyte-colony Stimulating Factor on Early Stage Parkinson's Disease (NCT NCT01227681)

Last Updated: 2016-04-04

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

2 years

Results posted on

2016-04-04

Participant Flow

Parkinson's disease research center, Tzu Chi Hospital

No participants were randomized to receive 1.65ug/kg/day of G-CSF and placebo

Participant milestones

Participant milestones
Measure	G-CSF 3.3ug/kg/day for consecutive 5 days of each 60 day cycle	Low Dose G-CSF 1.65ug/kg/day for consecutive 5 days of each 60 day cycle	Placebo subcutaneous Normal saline for consecutive 5 days of each 60 day cycle
Overall Study STARTED	4	0	0
Overall Study COMPLETED	4	0	0
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Dose G-CSF Injection for Parkinson's Disease n=4 Participants 3.3 ug/kg/day for consecutive 5 days of each 60 day cycle	Low Dose G-CSF Injection for Parkinson's Disease 1.65 ug/kg/day for consecutive 5 days of each 60 day cycle	Placebo normal saline 0.9% injection	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 participants n=5 Participants	—	—	0 participants n=4 Participants
Age, Categorical Between 18 and 65 years	4 participants n=5 Participants	—	—	4 participants n=4 Participants
Age, Categorical >=65 years	0 participants n=5 Participants	—	—	0 participants n=4 Participants
Age, Continuous	49.25 years n=5 Participants	—	—	49.25 years n=4 Participants
Gender Female	0 participants n=5 Participants	—	—	0 participants n=4 Participants
Gender Male	4 participants n=5 Participants	—	—	4 participants n=4 Participants
Region of Enrollment Taiwan	4 participants n=5 Participants	—	—	4 participants n=4 Participants

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	G-CSF Injection for Parkinson's Disease n=4 Participants 3.3ug/kg/day for consecutive 5 days of each 60 day cycle
Motor Performance of Unified Parkinson's Disease Rating Scale Baseline	23 scores on a scale Interval 17.0 to 27.0
Motor Performance of Unified Parkinson's Disease Rating Scale post G-CSF one year	22 scores on a scale Interval 18.0 to 25.0

Adverse Events

G-CSF Injection for Parkinson's Disease

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	G-CSF Injection for Parkinson's Disease n=4 participants at risk 3.3ug/kg/day for consecutive 5 days of each 60 day cycle
Musculoskeletal and connective tissue disorders Musculo-skeletal soreness	75.0% 3/4 • 2 years

Additional Information

Dr. Chen Shin-Yuan

Buddhist Tzu Chi General Hospital Hualien

Phone: +886-3-8561825

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place