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

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Fudan University

Status

Completed

Conditions

Idiopathic Parkinson's Disease

Treatments

Drug: pramipexole
Drug: Sinemet CR

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01470859
KY2011-283

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

30 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

pramipexole
Active Comparator group
Description:
0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients
Treatment:
Drug: pramipexole
Levodopa
Active Comparator group
Description:
Sinemet CR CR, Controlled Release
Treatment:
Drug: Sinemet CR

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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