Parkinson DiseasePhase 2NCT01227681
Study of the Neuro-protective Effect of Granulocyte-colony Stimulating Factor on Early Stage Parkinson's Disease
A Phase 2 study testing G-CSF in people with Parkinson Disease, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to evaluate the effectiveness of neuroprotection from granulocyte colony-stimulating factor on Parkinson disease Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- G-CSF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2010to Dec 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Placebo-Control, Study of the Neuro-protective Effect of Granulocyte-colony Stimulating Factor on Early Stage Parkinson's Disease
The purpose of this study is to evaluate the effectiveness of neuroprotection from granulocyte colony-stimulating factor on Parkinson disease
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- G-CSF, Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-CSFDrug
Also called Filgrastim, Kirin, Japan
G-CSF(granulocyte-colony stimulating factor) is planned injected subcutaneously
PlaceboDrug
Sodium Chloride (NaCl) 0.9 %
| Study group | Role | What they receive |
|---|---|---|
| high dose G-CSF | Experimental | high dose group: 3.3ug/kg/day for consecutive 5 days of each 60 day cycle (6 cycles) Receives: 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) Receives: Drug: G-CSF |
| placebo | Placebo comparator | Sodium Chloride (NaCl) 0.9 % Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Difficulty in Recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shin Yuan Chen, MD, Principal investigator, Buddhist Tzu Chi General Hospital, Hualien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01227681
- Sponsor's protocol ID
- TCSP-01
- Status last verified
- Mar 2016
- First submitted
- 22 Oct 2010
- Last updated
- 4 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Control, Study of the Neuro-protective Effect of Granulocyte-colony Stimulating Factor on Early Stage Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01227681
- Acronym / sponsor ID
- TCSP-01
- Conditions
- Parkinson Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in Recruitment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 25 Oct 2010 (estimated)
- Results
- Posted 4 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness of neuroprotection from granulocyte colony-stimulating factor on Parkinson disease
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| high dose G-CSF | Experimental | Drug: G-CSFhigh dose group: 3.3ug/kg/day for consecutive 5 days of each 60 day cycle (6 cycles) |
| low dose G-CSF | Active comparator | Drug: G-CSFlow dose group: 1.65ug/kg/day for consecutive 5 days of each 60 day cycle (6 cycles) |
| placebo | Placebo comparator | Drug: PlaceboSodium Chloride (NaCl) 0.9 % |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G-CSFAlso: Filgrastim, Kirin, JapanG-CSF(granulocyte-colony stimulating factor) is planned injected subcutaneously | Drug | high dose G-CSF, low dose G-CSF |
| PlaceboSodium Chloride (NaCl) 0.9 % | Drug | placebo |
Primary outcome
Motor Performance of Unified Parkinson's Disease Rating Scale
Time frame: 2 years
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shin Yuan Chen, MD principal investigator
Buddhist Tzu Chi General Hospital, Hualien
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing G-CSF in people with Parkinson Disease, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Performance of Unified Parkinson's Disease Rating Scale (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2016.