Clinical trial NCT01470859: The Effect of Pramipexole on Metabolic Network Activity Compared With Levodopa in Early Parkinson's Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Parkinson's Disease
Keywords: De Novo parkinson's disease
initial treatment
pramipexole
Levodopa
Parkinson's disease-related spatial covariance pattern
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
First posted: 2011-11-11
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: CALM-PD study found that Pramipexole can reduce the occurrence of motor complication compared with Levodopa used as initiative treatment, but it still remains debatable that initiation of which medication will be better for those patients with De Novo PD.

PDRP (Parkinson's disease-related spatial covariance pattern) is a biomarker which can represent the network activity of cortico-striato-pallido-thalamocortical pathways and highly reproducible with stable network activity in individual subjects. The study published in "J Neuroscience" in 2010 showed that the abnormal PDRP antecede the appearance of motor signs by about 2 years, indicating PDRP might be a very promising biomarker for identifying PD at its early stage. Moreover, PDRP is able to represent the progression and severity of PD as well. It was reported that Levodopa can reduce the PD-related network activity, and the degree of network suppression correlates with the clinical improvement. However, there is no study currently showing the impact of pramipexole on brain PDRP network compared with levodopa as initiative treatment.

Eligibility criteria: Inclusion Criteria:

* idiopathic Parkinson's disease meeting United Kingdom (UK) brain bank criteria
* De Novo
* Hoehn\&Yahr staging (H\&Y) I-II

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Longitudinal Change of Brain Network Activity
timeFrame: twice, baseline and 1 year after baseline
Secondary outcomes:
measure: Unified Parkinson's Disease Rating Score (UPDRS II, III)
timeFrame: three times: baseline, 10 weeks, 1 year
measure: Parkinson's Disease Questionnaire (PDQ39)
timeFrame: twice baseline and 1 year
measure: Hoehn&Yahr (H&Y) Staging
timeFrame: twice baseline and 1 year
measure: Patients With Clinical Improvement as Evaluated by Global Impression Scale (CGI).
timeFrame: twice, at 10 weeks(V2) and 1 year(V5)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital Affiliated to Fudan University
state: Shanghai
Study officials:
affiliation: Huashan Hospital
name: Jian Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Parkinson 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.
citation: Huang 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.
citation: Ma 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.
citation: Tang 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.
citation: Wang 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.