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

The Effect of Pramipexole on Metabolic Network Activity Compared With Levodopa in Early Parkinson's Disease

Sponsors

Lead sponsor: Huashan Hospital

Collaborator: Boehringer Ingelheim

Source Huashan Hospital
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.

Overall Status Completed
Start Date December 2011
Completion Date August 2014
Primary Completion Date August 2014
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Longitudinal Change of Brain Network Activity twice, baseline and 1 year after baseline
Secondary Outcome
Measure Time Frame
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)
Enrollment 30
Condition
Intervention

Intervention type: Drug

Intervention name: pramipexole

Description: 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.

Arm group label: pramipexole

Other name: Sifrol

Intervention type: Drug

Intervention name: Sinemet CR

Description: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year

Arm group label: Levodopa

Other name: Sinemet CR 250' (Levodopa 200mg, and 50mg carbidopa)

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.

Gender: All

Minimum age: 30 Years

Maximum age: 75 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Jian Wang, MD Principal Investigator Huashan Hospital
Location
facility Huashan Hospital Affiliated to Fudan University
Location Countries

China

Verification Date

September 2015

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Huashan Hospital

Investigator full name: Jian Wang

Investigator title: Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: pramipexole

Arm group type: Active Comparator

Description: 0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients

Arm group label: Levodopa

Arm group type: Active Comparator

Description: Sinemet CR CR, Controlled Release

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov