Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-27 @ 1:37 AM
Study NCT ID:
NCT01470859
Status:
COMPLETED
Last Update Posted:
2015-10-21
First Post:
2011-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Pramipexole on Metabolic Network Activity Compared With Levodopa in Early Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077487', 'term': 'Pramipexole'}, {'id': 'C009265', 'term': 'carbidopa, levodopa drug combination'}, {'id': 'D007980', 'term': 'Levodopa'}, {'id': 'D002230', 'term': 'Carbidopa'}], 'ancestors': [{'id': 'D052160', 'term': 'Benzothiazoles'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D004295', 'term': 'Dihydroxyphenylalanine'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010649', 'term': 'Phenylalanine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014443', 'term': 'Tyrosine'}, {'id': 'D008750', 'term': 'Methyldopa'}, {'id': 'D006834', 'term': 'Hydrazines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wangjian336@hotmail.com', 'phone': '+86-13321934789', 'title': 'Dr. Jian Wang', 'organization': 'Department of Neurology, Huashan Hospital affiliated to Fudan University.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'In the further study, a larger sample size and strict enrollment of early PD patients may enhance the accuracy of clinical trial conclusions.'}}, 'adverseEventsModule': {'timeFrame': '1 years', 'eventGroups': [{'id': 'EG000', 'title': 'Levodopa', 'description': 'Sinemet CR\n\nSinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year', 'otherNumAtRisk': 14, 'otherNumAffected': 4, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Pramipexole', 'description': '0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients\n\npramipexole: 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.', 'otherNumAtRisk': 15, 'otherNumAffected': 2, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Courbature', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Longitudinal Change of Brain Network Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Levodopa', 'description': 'Sinemet CR\n\nSinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year'}, {'id': 'OG001', 'title': 'Pramipexole', 'description': '0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients\n\npramipexole: 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.'}], 'classes': [{'title': 'Change from baseline (V5-V1)', 'categories': [{'measurements': [{'value': '0.41', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '0.61', 'spread': '0.68', 'groupId': 'OG001'}]}]}, {'title': 'Z score at baseline (V1)', 'categories': [{'measurements': [{'value': '2.21', 'spread': '1.54', 'groupId': 'OG000'}, {'value': '3.61', 'spread': '1.77', 'groupId': 'OG001'}]}]}, {'title': 'Z score at 1 year (V5)', 'categories': [{'measurements': [{'value': '2.29', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '4.09', 'spread': '1.07', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.84', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': '"p\\<0.05" is indicating the threshold for statistical significance for this comparison', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'independent sample t-test The statistical analysis was performed on the changes of PDRP Z score between levodopa and pramipexole groups.', 'testedNonInferiority': False}, {'pValue': '0.93', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': '"p\\<0.05" is indicating the threshold for statistical significance for this comparison', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'independent sample t-test The statistical analysis was performed to compare the PDRP Z scores between levodopa and pramipexole groups at V1', 'testedNonInferiority': False}, {'pValue': '0.31', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': '"p\\<0.05" is indicating the threshold for statistical significance for this comparison', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'independent sample t-test The statistical analysis was performed to compare the PDRP Z scores between levodopa and pramipexole groups at V5', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'twice, baseline and 1 year after baseline', 'description': "The brain network activity is evaluated by Parkinson's disease-related spatial covariance pattern(PDRP) value (Z score).\n\nThe change of brain network activity is calculated by the PDRP value (Z score) at V5 - the PDRP value (Z score) at V1.", 'unitOfMeasure': 'Z-score in PDRP', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Unified Parkinson's Disease Rating Score (UPDRS II, III)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Levodopa', 'description': 'Sinemet CR\n\nSinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year'}, {'id': 'OG001', 'title': 'Pramipexole', 'description': '0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients\n\npramipexole: 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.'}], 'classes': [{'title': 'UPDRS II at baseline (V1)', 'categories': [{'measurements': [{'value': '7.3', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'UPDRS II (V2)', 'categories': [{'measurements': [{'value': '5.8', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '3.3', 'groupId': 'OG001'}]}]}, {'title': 'UPDRS II at 1 year (V5)', 'categories': [{'measurements': [{'value': '7.4', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '8.4', 'spread': '3.0', 'groupId': 'OG001'}]}]}, {'title': 'UPDRS III at baseline (V1)', 'categories': [{'measurements': [{'value': '18.7', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '23.1', 'spread': '10.4', 'groupId': 'OG001'}]}]}, {'title': 'UPDRS III (V2)', 'categories': [{'measurements': [{'value': '12.7', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '20.1', 'spread': '8.9', 'groupId': 'OG001'}]}]}, {'title': 'UPDRS III at 1 year (V5)', 'categories': [{'measurements': [{'value': '19.5', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '24.3', 'spread': '8.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.691', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': '"p\\<0.05" is indicating the threshold for statistical significance for this comparison', 'statisticalMethod': 'independent U test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'independent U test The statistical analysis was performed to compare the UPDRS II scores at V1 scores between the levodopa and pramipexole groups', 'testedNonInferiority': False}, {'pValue': '0.706', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': '"p\\<0.05" is indicating the threshold for statistical significance for this comparison', 'statisticalMethod': 'independent U test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'independent U test The statistical analysis was performed to compare the UPDRS II scores at V2 scores between the levodopa and pramipexole groups', 'testedNonInferiority': False}, {'pValue': '0.635', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': '"p\\<0.05" is indicating the threshold for statistical significance for this comparison', 'statisticalMethod': 'independent U test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'independent U test The statistical analysis was performed to compare the UPDRS II scores at V5 scores between the levodopa and pramipexole groups', 'testedNonInferiority': False}, {'pValue': '0.341', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': '"p\\<0.05" is indicating the threshold for statistical significance for this comparison', 'statisticalMethod': 'independent U test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'independent U test The statistical analysis was performed to compare the UPDRS III scores at V1 scores between the levodopa and pramipexole groups', 'testedNonInferiority': False}, {'pValue': '0.049', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': '"p\\<0.05" is indicating the threshold for statistical significance for this comparison', 'statisticalMethod': 'independent U test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'independent U test The statistical analysis was performed to compare the UPDRS III scores at V2 scores between the levodopa and pramipexole groups', 'testedNonInferiority': False}, {'pValue': '0.874', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': '"p\\<0.05" is indicating the threshold for statistical significance for this comparison', 'statisticalMethod': 'independent U test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'independent U test The statistical analysis was performed to compare the UPDRS III scores at V5 scores between the levodopa and pramipexole groups', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'three times: baseline, 10 weeks, 1 year', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Parkinson's Disease Questionnaire (PDQ39)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Levodopa', 'description': 'Sinemet CR\n\nSinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year'}, {'id': 'OG001', 'title': 'Pramipexole', 'description': '0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients\n\npramipexole: 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.'}], 'classes': [{'title': 'PDQ39 at baseline (V1)', 'categories': [{'measurements': [{'value': '19.38', 'spread': '10.94', 'groupId': 'OG000'}, {'value': '20.36', 'spread': '16.49', 'groupId': 'OG001'}]}]}, {'title': 'PDQ39 at 1 year (V5)', 'categories': [{'measurements': [{'value': '20.36', 'spread': '16.49', 'groupId': 'OG000'}, {'value': '21.07', 'spread': '12.96', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.720', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': '"p\\<0.05" is indicating the threshold for statistical significance for this comparison', 'statisticalMethod': 'independent U test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'independent U test The statistical analysis was performed to compare the PDQ39 scores between levodopa and pramipexole group at V1', 'testedNonInferiority': False}, {'pValue': '0.867', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': '"p\\<0.05" is indicating the threshold for statistical significance for this comparison', 'statisticalMethod': 'independent U test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'independent U test The statistical analysis was performed to compare the PDQ39 scores between levodopa and pramipexole group at V5', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'twice baseline and 1 year', 'description': 'The PDQ39 score was assessed at baseline (1st visit, V1) and 1 year after baseline (final visit, V5).\n\nPDQ39 score ranges from 0-156 (0-4 each item); the more score, the more severe.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hoehn&Yahr (H&Y) Staging', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Levodopa', 'description': 'Sinemet CR\n\nSinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year'}, {'id': 'OG001', 'title': 'Pramipexole', 'description': '0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients\n\npramipexole: 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.'}], 'classes': [{'title': 'H&Y at baseline（V1）', 'categories': [{'measurements': [{'value': '1.35', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '1.43', 'spread': '0.51', 'groupId': 'OG001'}]}]}, {'title': 'H&Y at 1 year（V5）', 'categories': [{'measurements': [{'value': '1.65', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '1.82', 'spread': '0.54', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.793', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': '"p\\<0.05" is indicating the threshold for statistical significance for this comparison', 'statisticalMethod': 'indenpendent U test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'independent U test The statistical analysis was performed to compare the H\\&Y stages between levodopa and pramipexole group at V1', 'testedNonInferiority': False}, {'pValue': '0.430', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': '"p\\<0.05" is indicating the threshold for statistical significance for this comparison', 'statisticalMethod': 'independent U test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'independent U test The statistical analysis was performed to compare the H\\&Y stages between levodopa and pramipexole groups at V5', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'twice baseline and 1 year', 'description': "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.\n\nThe H\\&Y stages of patients were evaluated at baseline (1st visit, V1), and 1 year after baseline (final visit, V5).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patients With Clinical Improvement as Evaluated by Global Impression Scale (CGI).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Levodopa', 'description': 'Sinemet CR\n\nSinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year'}, {'id': 'OG001', 'title': 'Pramipexole', 'description': '0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients\n\npramipexole: 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.'}], 'classes': [{'title': 'Patients with improvement at V2', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Patients with improvement at V5', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.345', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': '"p\\<0.05" is indicating the threshold for statistical significance for this comparison', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The statistical analysis was performed to compare the clinical improvement between levodopa and pramipexole groups at V2', 'testedNonInferiority': False}, {'pValue': '0.410', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': '"p\\<0.05" is indicating the threshold for statistical significance for this comparison', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The statistical analysis was performed to compare the clinical improvement between levodopa and pramipexole groups at V5', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'twice, at 10 weeks(V2) and 1 year(V5)', 'description': 'Patients with a score \\<= 2 (very much or much improved in relation to baseline) are considered as clinically improved.\n\nThe 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)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Levodopa', 'description': 'Sinemet Controlled Release (CR)\n\nSinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year'}, {'id': 'FG001', 'title': 'Pramipexole', 'description': '0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients\n\npramipexole: 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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pramipexole', 'description': '0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients\n\npramipexole: 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.'}, {'id': 'BG001', 'title': 'Levodopa', 'description': 'Sinemet CR\n\nSinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.87', 'spread': '5.68', 'groupId': 'BG000'}, {'value': '61.9', 'spread': '6.66', 'groupId': 'BG001'}, {'value': '62.9', 'spread': '6.14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-21', 'studyFirstSubmitDate': '2011-11-09', 'resultsFirstSubmitDate': '2015-06-23', 'studyFirstSubmitQcDate': '2011-11-10', 'lastUpdatePostDateStruct': {'date': '2015-10-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-09-21', 'studyFirstPostDateStruct': {'date': '2011-11-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Longitudinal Change of Brain Network Activity', 'timeFrame': 'twice, baseline and 1 year after baseline', 'description': "The brain network activity is evaluated by Parkinson's disease-related spatial covariance pattern(PDRP) value (Z score).\n\nThe change of brain network activity is calculated by the PDRP value (Z score) at V5 - the PDRP value (Z score) at V1."}], 'secondaryOutcomes': [{'measure': "Unified Parkinson's Disease Rating Score (UPDRS II, III)", 'timeFrame': 'three times: baseline, 10 weeks, 1 year', 'description': '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.'}, {'measure': "Parkinson's Disease Questionnaire (PDQ39)", 'timeFrame': 'twice baseline and 1 year', 'description': 'The PDQ39 score was assessed at baseline (1st visit, V1) and 1 year after baseline (final visit, V5).\n\nPDQ39 score ranges from 0-156 (0-4 each item); the more score, the more severe.'}, {'measure': 'Hoehn&Yahr (H&Y) Staging', 'timeFrame': 'twice baseline and 1 year', 'description': "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.\n\nThe H\\&Y stages of patients were evaluated at baseline (1st visit, V1), and 1 year after baseline (final visit, V5)."}, {'measure': 'Patients With Clinical Improvement as Evaluated by Global Impression Scale (CGI).', 'timeFrame': 'twice, at 10 weeks(V2) and 1 year(V5)', 'description': 'Patients with a score \\<= 2 (very much or much improved in relation to baseline) are considered as clinically improved.\n\nThe 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)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["De Novo parkinson's disease", 'initial treatment', 'pramipexole', 'Levodopa', "Parkinson's disease-related spatial covariance pattern"], 'conditions': ["Idiopathic Parkinson's Disease"]}, 'referencesModule': {'references': [{'pmid': '17161393', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '15710852', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '17470495', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '16804550', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '20089913', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '19662326', 'type': 'BACKGROUND', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': "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.\n\nParkinson'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.", 'detailedDescription': '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.\n\nPDRP (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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* idiopathic Parkinson's disease meeting United Kingdom (UK) brain bank criteria\n* De Novo\n* Hoehn\\&Yahr staging (H\\&Y) I-II\n\nExclusion Criteria:\n\n* Atypical Parkinsonism\n* Pregnant or breast-feeding women\n* those with abnormal Liver/kidney function\n* those participating other clinical trials within 30 days before being enrolled for this trial."}, 'identificationModule': {'nctId': 'NCT01470859', 'briefTitle': "The Effect of Pramipexole on Metabolic Network Activity Compared With Levodopa in Early Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Huashan Hospital'}, 'officialTitle': "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", 'orgStudyIdInfo': {'id': 'KY2011-283'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'pramipexole', 'description': '0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients', 'interventionNames': ['Drug: pramipexole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Levodopa', 'description': 'Sinemet CR CR， Controlled Release', 'interventionNames': ['Drug: Sinemet CR']}], 'interventions': [{'name': 'pramipexole', 'type': 'DRUG', 'otherNames': ['Sifrol'], '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.', 'armGroupLabels': ['pramipexole']}, {'name': 'Sinemet CR', 'type': 'DRUG', 'otherNames': ["Sinemet CR 250' (Levodopa 200mg, and 50mg carbidopa)"], 'description': 'tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year', 'armGroupLabels': ['Levodopa']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200040', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Huashan Hospital Affiliated to Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Jian Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Huashan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huashan Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jian Wang', 'investigatorAffiliation': 'Huashan Hospital'}}}}