Trial · NCT01470859
The Effect of Pramipexole on Metabolic Network Activity Compared With Levodopa in Early Parkinson's Disease
NCT01470859, Not applicable, Completed, Huashan Hospital; results first posted 2015-10-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Effect of Pramipexole on Metabolic Network Activity Compared With Levodopa in Early Parkinson's Disease. Trials, record NCT01470859. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01470859
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effect of Pramipexole on Metabolic Network Activity Compared With Levodopa in Early Parkinson's Disease
- NCT number
- NCT01470859
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 30 participants, actual
- Lead sponsor
- Huashan Hospital
- Conditions
- Idiopathic Parkinson's Disease
- Interventions
- pramipexole, Sinemet CR
- First posted
- 2011-11-11
- Last updated
- 2015-10-21
- Results first posted
- 2015-10-21
- Limitations and caveats
- In the further study, a larger sample size and strict enrollment of early PD patients may enhance the accuracy of clinical trial conclusions.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Longitudinal Change of Brain Network Activity | twice, baseline and 1 year after baseline | 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. |
| Secondary | Unified Parkinson's Disease Rating Score (UPDRS II, III) | three times: baseline, 10 weeks, 1 year | 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. |
| Secondary | Parkinson's Disease Questionnaire (PDQ39) | twice baseline and 1 year | 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. |
| Secondary | Hoehn&Yahr (H&Y) Staging | twice baseline and 1 year | 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). |
| Secondary | Patients With Clinical Improvement as Evaluated by Global Impression Scale (CGI). | twice, at 10 weeks(V2) and 1 year(V5) | 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) |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Longitudinal Change of Brain Network Activity | twice, baseline and 1 year after baseline | Z-score in PDRP | MEAN | |
| SECONDARY | Unified Parkinson's Disease Rating Score (UPDRS II, III) | three times: baseline, 10 weeks, 1 year | units on a scale | MEAN | |
| SECONDARY | Parkinson's Disease Questionnaire (PDQ39) | twice baseline and 1 year | units on a scale | MEAN | |
| SECONDARY | Hoehn&Yahr (H&Y) Staging | twice baseline and 1 year | units on a scale | MEAN | |
| SECONDARY | Patients With Clinical Improvement as Evaluated by Global Impression Scale (CGI). | twice, at 10 weeks(V2) and 1 year(V5) | participants | NUMBER |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Longitudinal Change of Brain Network Activity | Levodopa | Change from baseline (V5-V1) | 0.41 | Standard Deviation 0.70 | Z-score in PDRP |
| Longitudinal Change of Brain Network Activity | Pramipexole | Change from baseline (V5-V1) | 0.61 | Standard Deviation 0.68 | Z-score in PDRP |
| Longitudinal Change of Brain Network Activity | Levodopa | Z score at baseline (V1) | 2.21 | Standard Deviation 1.54 | Z-score in PDRP |
| Longitudinal Change of Brain Network Activity | Pramipexole | Z score at baseline (V1) | 3.61 | Standard Deviation 1.77 | Z-score in PDRP |
| Longitudinal Change of Brain Network Activity | Levodopa | Z score at 1 year (V5) | 2.29 | Standard Deviation 1.24 | Z-score in PDRP |
| Longitudinal Change of Brain Network Activity | Pramipexole | Z score at 1 year (V5) | 4.09 | Standard Deviation 1.07 | Z-score in PDRP |
| Unified Parkinson's Disease Rating Score (UPDRS II, III) | Levodopa | UPDRS II at baseline (V1) | 7.3 | Standard Deviation 3.5 | units on a scale |
| Unified Parkinson's Disease Rating Score (UPDRS II, III) | Pramipexole | UPDRS II at baseline (V1) | 7.1 | Standard Deviation 2.9 | units on a scale |
| Unified Parkinson's Disease Rating Score (UPDRS II, III) | Levodopa | UPDRS II (V2) | 5.8 | Standard Deviation 3.5 | units on a scale |
| Unified Parkinson's Disease Rating Score (UPDRS II, III) | Pramipexole | UPDRS II (V2) | 4.9 | Standard Deviation 3.3 | units on a scale |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Levodopa | 15 | |
| Overall Study | STARTED | Pramipexole | 15 | |
| Overall Study | COMPLETED | Levodopa | 14 | |
| Overall Study | COMPLETED | Pramipexole | 15 | |
| Overall Study | NOT COMPLETED | Levodopa | 1 | |
| Overall Study | NOT COMPLETED | Pramipexole | 0 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Somnolence | Nervous system disorders | Levodopa | 0 | 14 | |
| other | Somnolence | Nervous system disorders | Pramipexole | 2 | 15 | |
| other | Insomnia | Nervous system disorders | Levodopa | 1 | 14 | |
| other | Insomnia | Nervous system disorders | Pramipexole | 0 | 15 | |
| other | Dizziness | Nervous system disorders | Levodopa | 1 | 14 | |
| other | Dizziness | Nervous system disorders | Pramipexole | 0 | 15 | |
| other | Gastritis | Gastrointestinal disorders | Levodopa | 1 | 14 | |
| other | Gastritis | Gastrointestinal disorders | Pramipexole | 0 | 15 | |
| other | Courbature | Musculoskeletal and connective tissue disorders | Levodopa | 1 | 14 | |
| other | Courbature | Musculoskeletal and connective tissue disorders | Pramipexole | 0 | 15 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Levodopa | ||
| Total, all-cause mortality | Pramipexole | ||
| Total, other adverse events | Levodopa | 4 | 14 |
| Total, other adverse events | Pramipexole | 2 | 15 |
| Total, serious adverse events | Levodopa | 0 | 14 |
| Total, serious adverse events | Pramipexole | 0 | 15 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Levodopa vs Pramipexole: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01470859
GET https://conductscience.org/api/trials/v1/NCT01470859/results?page=2