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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pramipexole | Active Comparator | 0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients |
|
| Levodopa | Active Comparator | Sinemet CR CR， Controlled Release |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pramipexole | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Unified Parkinson's Disease Rating Score (UPDRS II, III) | baseline (1st visit, V1), completion of dosage titration within 10 weeks after baseline (2nd visit, V2), 1 year after baseline (final visit, V5) UPDRS II score 0-52 (13 items); UPDRS III score 0-56 (14 items); The more scores,the more severe; the two scales were evaluated separately. | three times: baseline, 10 weeks, 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jian Wang, MD | Huashan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital Affiliated to Fudan University | Shanghai | Shanghai Municipality | 200040 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17161393 | Background | 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. | |
| 15710852 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Levodopa | Sinemet Controlled Release (CR) Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year |
| FG001 | Pramipexole | 0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients pramipexole: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pramipexole | 0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients pramipexole: 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. |
| BG001 | Levodopa |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Z-score in PDRP | twice, baseline and 1 year after baseline |
|
1 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Levodopa | Sinemet CR Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | Non-systematic Assessment |
In the further study, a larger sample size and strict enrollment of early PD patients may enhance the accuracy of clinical trial conclusions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jian Wang | Department of Neurology, Huashan Hospital affiliated to Fudan University. | +86-13321934789 | wangjian336@hotmail.com |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077487 | Pramipexole |
| C009265 | carbidopa, levodopa drug combination |
| D007980 | Levodopa |
| D002230 | Carbidopa |
| ID | Term |
|---|---|
| D052160 | Benzothiazoles |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
| Sinemet CR | Drug | tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year |
|
|
| Parkinson's Disease Questionnaire (PDQ39) | The PDQ39 score was assessed at baseline (1st visit, V1) and 1 year after baseline (final visit, V5). PDQ39 score ranges from 0-156 (0-4 each item); the more score, the more severe. | twice baseline and 1 year |
| Hoehn&Yahr (H&Y) Staging | The Hoehn and Yahr scale is a commonly used scale for describing how the symptoms of Parkinson's disease progress and the disease stages. Bigger numbers indicate more symptoms and disease progression. H&Y stage range from 0-5; the greater, the more severe. The H&Y stages of patients were evaluated at baseline (1st visit, V1), and 1 year after baseline (final visit, V5). | twice baseline and 1 year |
| Patients With Clinical Improvement as Evaluated by Global Impression Scale (CGI). | Patients with a score <= 2 (very much or much improved in relation to baseline) are considered as clinically improved. The numbers of participants with clinical improvement are reported here. The completion of dosage titration within 10 weeks after baseline (visit 2) and 1 year after baseline (final visit) | twice, at 10 weeks(V2) and 1 year(V5) |
| 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. |
| 17470495 | Background | 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. |
| 16804550 | Background | 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. |
| 20089913 | Background | 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. |
| 19662326 | Background | 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. |
Sinemet CR Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Unified Parkinson's Disease Rating Score (UPDRS II, III) | baseline (1st visit, V1), completion of dosage titration within 10 weeks after baseline (2nd visit, V2), 1 year after baseline (final visit, V5) UPDRS II score 0-52 (13 items); UPDRS III score 0-56 (14 items); The more scores,the more severe; the two scales were evaluated separately. | Posted | Mean | Standard Deviation | units on a scale | three times: baseline, 10 weeks, 1 year |
|
|
|
|
| Secondary | Parkinson's Disease Questionnaire (PDQ39) | The PDQ39 score was assessed at baseline (1st visit, V1) and 1 year after baseline (final visit, V5). PDQ39 score ranges from 0-156 (0-4 each item); the more score, the more severe. | Posted | Mean | Standard Deviation | units on a scale | twice baseline and 1 year |
|
|
|
|
| Secondary | Hoehn&Yahr (H&Y) Staging | The Hoehn and Yahr scale is a commonly used scale for describing how the symptoms of Parkinson's disease progress and the disease stages. Bigger numbers indicate more symptoms and disease progression. H&Y stage range from 0-5; the greater, the more severe. The H&Y stages of patients were evaluated at baseline (1st visit, V1), and 1 year after baseline (final visit, V5). | Posted | Mean | Standard Deviation | units on a scale | twice baseline and 1 year |
|
|
|
|
| Secondary | Patients With Clinical Improvement as Evaluated by Global Impression Scale (CGI). | Patients with a score <= 2 (very much or much improved in relation to baseline) are considered as clinically improved. The numbers of participants with clinical improvement are reported here. The completion of dosage titration within 10 weeks after baseline (visit 2) and 1 year after baseline (final visit) | Posted | Number | participants | twice, at 10 weeks(V2) and 1 year(V5) |
|
|
|
|
| 0 |
| 14 |
| 4 |
| 14 |
| EG001 | Pramipexole | 0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients pramipexole: 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. | 0 | 15 | 2 | 15 |
| Insomnia | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Courbature | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D006571 |
| Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004295 | Dihydroxyphenylalanine |
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014443 | Tyrosine |
| D008750 | Methyldopa |
| D006834 | Hydrazines |
| UPDRS II at 1 year (V5) |
|
| UPDRS III at baseline (V1) |
|
| UPDRS III (V2) |
|
| UPDRS III at 1 year (V5) |
|
| independent U test |
independent U test The statistical analysis was performed to compare the UPDRS II scores at V2 scores between the levodopa and pramipexole groups |
| 0.706 |
"p<0.05" is indicating the threshold for statistical significance for this comparison |
| 2-Sided |
| No |
| Superiority or Other |
| independent U test | independent U test The statistical analysis was performed to compare the UPDRS II scores at V5 scores between the levodopa and pramipexole groups | 0.635 | "p<0.05" is indicating the threshold for statistical significance for this comparison | 2-Sided | No | Superiority or Other |
| independent U test | independent U test The statistical analysis was performed to compare the UPDRS III scores at V1 scores between the levodopa and pramipexole groups | 0.341 | "p<0.05" is indicating the threshold for statistical significance for this comparison | 2-Sided | No | Superiority or Other |
| independent U test | independent U test The statistical analysis was performed to compare the UPDRS III scores at V2 scores between the levodopa and pramipexole groups | 0.049 | "p<0.05" is indicating the threshold for statistical significance for this comparison | 2-Sided | No | Superiority or Other |
| independent U test | independent U test The statistical analysis was performed to compare the UPDRS III scores at V5 scores between the levodopa and pramipexole groups | 0.874 | "p<0.05" is indicating the threshold for statistical significance for this comparison | 2-Sided | No | Superiority or Other |
| independent U test |
independent U test The statistical analysis was performed to compare the PDQ39 scores between levodopa and pramipexole group at V5 |
| 0.867 |
"p<0.05" is indicating the threshold for statistical significance for this comparison |
| 2-Sided |
| No |
| Superiority or Other |
| independent U test |
independent U test The statistical analysis was performed to compare the H&Y stages between levodopa and pramipexole groups at V5 |
| 0.430 |
"p<0.05" is indicating the threshold for statistical significance for this comparison |
| 2-Sided |
| No |
| Superiority or Other |
| Chi-squared |
The statistical analysis was performed to compare the clinical improvement between levodopa and pramipexole groups at V5 |
| 0.410 |
"p<0.05" is indicating the threshold for statistical significance for this comparison |
| 2-Sided |
| No |
| Superiority or Other |