The Effect of Pramipexole on Metabolic Network Activity Compared With Levodopa in Early Parkinson's Disease
a Pilot Follow-up Study of Investigating the Effect of Pramipexole on Metabolic Network Activity Compared With Levodopa in Chinese Patients With Early Parkinson's Disease
1 other identifier
interventional
30
1 country
1
Brief Summary
Levodopa and non-ergot dopaminergic agonists such as pramipexole are both recommended as the first-line symptomatic treatment for early untreated Parkinson's disease (PD), previous clinical trial indicated that initial pramipexole owns advantage over levodopa regarding motor complications, on the contrary, less adverse effect like freezing and severe somnolence favors initial treatment of levodopa. Thus, it remains controversial that initiation of which medication will be better for those patients with early PD. Parkinson's disease-related spatial covariance patter (PDRP) is a new biomarker which can represent the network activity of brain and severity of PD. Based on the literatures and our previous data, the investigators hypothesize that PDRP will be served as a biomarker to help us evaluate and compare the effect of levodopa or pramipexole on the progression of PD, which might be able to provide further evidence for clinicians to address the above critical issue.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2011
CompletedFirst Posted
Study publicly available on registry
November 11, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
October 21, 2015
CompletedOctober 21, 2015
September 1, 2015
2.7 years
November 9, 2011
June 23, 2015
September 21, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Longitudinal Change of Brain Network Activity
The brain network activity is evaluated by Parkinson's disease-related spatial covariance pattern(PDRP) value (Z score). The change of brain network activity is calculated by the PDRP value (Z score) at V5 - the PDRP value (Z score) at V1.
twice, baseline and 1 year after baseline
Secondary Outcomes (4)
Unified Parkinson's Disease Rating Score (UPDRS II, III)
three times: baseline, 10 weeks, 1 year
Parkinson's Disease Questionnaire (PDQ39)
twice baseline and 1 year
Hoehn&Yahr (H&Y) Staging
twice baseline and 1 year
Patients With Clinical Improvement as Evaluated by Global Impression Scale (CGI).
twice, at 10 weeks(V2) and 1 year(V5)
Study Arms (2)
pramipexole
ACTIVE COMPARATOR0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients
Levodopa
ACTIVE COMPARATORSinemet CR CR， Controlled Release
Interventions
tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year.
tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year
Eligibility Criteria
You may qualify if:
- idiopathic Parkinson's disease meeting United Kingdom (UK) brain bank criteria
- De Novo
- Hoehn\&Yahr staging (H\&Y) I-II
You may not qualify if:
- Atypical Parkinsonism
- Pregnant or breast-feeding women
- those with abnormal Liver/kidney function
- those participating other clinical trials within 30 days before being enrolled for this trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Huashan Hospitallead
- Boehringer Ingelheimcollaborator
Study Sites (1)
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040, China
Related Publications (6)
Izumi Y, Sawada H, Yamamoto N, Kume T, Katsuki H, Shimohama S, Akaike A. Novel neuroprotective mechanisms of pramipexole, an anti-Parkinson drug, against endogenous dopamine-mediated excitotoxicity. Eur J Pharmacol. 2007 Feb 28;557(2-3):132-40. doi: 10.1016/j.ejphar.2006.11.011. Epub 2006 Nov 14.
PMID: 17161393BACKGROUNDParkinson Study Group. A randomized placebo-controlled trial of rasagiline in levodopa-treated patients with Parkinson disease and motor fluctuations: the PRESTO study. Arch Neurol. 2005 Feb;62(2):241-8. doi: 10.1001/archneur.62.2.241.
PMID: 15710852BACKGROUNDHuang C, Tang C, Feigin A, Lesser M, Ma Y, Pourfar M, Dhawan V, Eidelberg D. Changes in network activity with the progression of Parkinson's disease. Brain. 2007 Jul;130(Pt 7):1834-46. doi: 10.1093/brain/awm086. Epub 2007 Apr 30.
PMID: 17470495BACKGROUNDMa Y, Tang C, Spetsieris PG, Dhawan V, Eidelberg D. Abnormal metabolic network activity in Parkinson's disease: test-retest reproducibility. J Cereb Blood Flow Metab. 2007 Mar;27(3):597-605. doi: 10.1038/sj.jcbfm.9600358. Epub 2006 Jun 28.
PMID: 16804550BACKGROUNDTang CC, Poston KL, Dhawan V, Eidelberg D. Abnormalities in metabolic network activity precede the onset of motor symptoms in Parkinson's disease. J Neurosci. 2010 Jan 20;30(3):1049-56. doi: 10.1523/JNEUROSCI.4188-09.2010.
PMID: 20089913BACKGROUNDWang J, Ma Y, Huang Z, Sun B, Guan Y, Zuo C. Modulation of metabolic brain function by bilateral subthalamic nucleus stimulation in the treatment of Parkinson's disease. J Neurol. 2010 Jan;257(1):72-8. doi: 10.1007/s00415-009-5267-3. Epub 2009 Aug 7.
PMID: 19662326BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
In the further study, a larger sample size and strict enrollment of early PD patients may enhance the accuracy of clinical trial conclusions.
Results Point of Contact
- Title
- Dr. Jian Wang
- Organization
- Department of Neurology, Huashan Hospital affiliated to Fudan University.
Study Officials
- PRINCIPAL INVESTIGATOR
Jian Wang, MD
Huashan Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 9, 2011
First Posted
November 11, 2011
Study Start
December 1, 2011
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
October 21, 2015
Results First Posted
October 21, 2015
Record last verified: 2015-09