N/A
Completed N=30
The Effect of Pramipexole on Metabolic Network Activity Compared With Levodopa in Early Parkinson's Disease
Source: ClinicalTrials.gov NCT01470859 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Oct 2015
Primary outcomePrimary: Longitudinal Change of Brain Network Activity — 0.41; 0.61; 2.21; 3.61 Z-score in PDRP — p=0.84
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Longitudinal Change of Brain Network Activity |
0.41; 0.61; 2.21; 3.61; 2.29; 4.09 | 0.84 |
| SECONDARY Unified Parkinson's Disease Rating Score (UPDRS II, III) |
7.3; 7.1; 5.8; 4.9; 7.4; 8.4 | 0.691 |
| SECONDARY Parkinson's Disease Questionnaire (PDQ39) |
19.38; 20.36; 20.36; 21.07 | 0.720 |
| SECONDARY Hoehn&Yahr (H&Y) Staging |
1.35; 1.43; 1.65; 1.82 | 0.793 |
| SECONDARY Patients With Clinical Improvement as Evaluated by Global Impression Scale (CGI). |
6; 4; 2; 4 | 0.345 |
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.
Data sourced from ClinicalTrials.gov (NCT01470859). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.