Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:30 AM
Study NCT ID:
NCT00402233
Status:
COMPLETED
Last Update Posted:
2014-05-16
First Post:
2006-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Randomized, Double-blind, Active (Pramipexole 0.5 mg Tid) and Placebo Controlled, Study of Pramipexole Given 0.5 mg and 0.75 mg Bid Over 12-week Treatment in Early Parkinson's Disease (PD) Patients
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'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'matching tablet', 'otherNumAtRisk': 77, 'otherNumAffected': 27, 'seriousNumAtRisk': 77, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Mirapex (Pramipexole 0.5 mg Bid)', 'description': 'Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.', 'otherNumAtRisk': 81, 'otherNumAffected': 42, 'seriousNumAtRisk': 81, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Mirapex (Pramipexole 0.75 mg Bid)', 'description': 'Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.', 'otherNumAtRisk': 73, 'otherNumAffected': 37, 'seriousNumAtRisk': 73, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Mirapex (Pramipexole 0.5 mg Tid)', 'description': 'Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.', 'otherNumAtRisk': 80, 'otherNumAffected': 43, 'seriousNumAtRisk': 80, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 12.0'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 12.0'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 12.0'}, {'term': 'tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 12.0'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 12.0'}, {'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 12.0'}, {'term': 'insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 12.0'}, {'term': 'abnormal dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 12.0'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 12.0'}, {'term': 'oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 12.0'}], 'seriousEvents': [{'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 12.0'}, {'term': 'Cerebral Infarction, Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 12.0'}, {'term': 'ileus (patient stopped drugs 2 days prior)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDRA 12.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Unified Parkinson's Disease Rating Scale (UPDRS) Total Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'matching tablet'}, {'id': 'OG001', 'title': 'Mirapex (Pramipexole 0.5 mg Tid)', 'description': 'Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.'}, {'id': 'OG002', 'title': 'Mirapex (Pramipexole 0.5 mg Bid)', 'description': 'Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.'}, {'id': 'OG003', 'title': 'Mirapex (Pramipexole 0.75 mg Bid)', 'description': 'Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.'}], 'classes': [{'title': 'UPDRS at baseline', 'categories': [{'measurements': [{'value': '28.97', 'spread': '11.82', 'groupId': 'OG000'}, {'value': '27.66', 'spread': '10.72', 'groupId': 'OG001'}, {'value': '27.21', 'spread': '11.76', 'groupId': 'OG002'}, {'value': '27.77', 'spread': '9.18', 'groupId': 'OG003'}]}]}, {'title': 'UPDRS at week 12', 'categories': [{'measurements': [{'value': '28.19', 'spread': '12.94', 'groupId': 'OG000'}, {'value': '22.92', 'spread': '10.44', 'groupId': 'OG001'}, {'value': '22.96', 'spread': '11.94', 'groupId': 'OG002'}, {'value': '22.65', 'spread': '10.82', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-4.4', 'ciLowerLimit': '-6.53', 'ciUpperLimit': '-2.26', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-4.41', 'ciLowerLimit': '-6.54', 'ciUpperLimit': '-2.28', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-4.72', 'ciLowerLimit': '-6.91', 'ciUpperLimit': '-2.52', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to week 12', 'description': 'Total score ranges from zero (best) to 176 (worst), as the sum of Parts I (Mental questions), II (Activity of Daily Living questions), and III (Motor examination)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Modified Hoehn and Yahr Stage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'matching tablet'}, {'id': 'OG001', 'title': 'Mirapex (Pramipexole 0.5 mg Tid)', 'description': 'Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.'}, {'id': 'OG002', 'title': 'Mirapex (Pramipexole 0.5 mg Bid)', 'description': 'Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.'}, {'id': 'OG003', 'title': 'Mirapex (Pramipexole 0.75 mg Bid)', 'description': 'Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.'}], 'classes': [{'title': 'Modified Hoehn and Yahr Stage at baseline', 'categories': [{'measurements': [{'value': '1.81', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '1.74', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '1.72', 'spread': '0.5', 'groupId': 'OG002'}, {'value': '1.73', 'spread': '0.51', 'groupId': 'OG003'}]}]}, {'title': 'Modified Hoehn and Yahr Stage at week 12', 'categories': [{'measurements': [{'value': '1.74', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '1.68', 'spread': '0.52', 'groupId': 'OG001'}, {'value': '1.69', 'spread': '0.52', 'groupId': 'OG002'}, {'value': '1.62', 'spread': '0.56', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '0.893', 'ciLowerLimit': '0.431', 'ciUpperLimit': '1.849', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '0.885', 'ciLowerLimit': '0.424', 'ciUpperLimit': '1.845', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '0.687', 'ciLowerLimit': '0.317', 'ciUpperLimit': '1.492', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to week 12', 'description': 'Score ranges from best 0 (no signs of disease) to worst 5 (wheelchair bound or bedridden unless aided)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Epworth Sleepiness Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'matching tablet'}, {'id': 'OG001', 'title': 'Mirapex (Pramipexole 0.5 mg Tid)', 'description': 'Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.'}, {'id': 'OG002', 'title': 'Mirapex (Pramipexole 0.5 mg Bid)', 'description': 'Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.'}, {'id': 'OG003', 'title': 'Mirapex (Pramipexole 0.75 mg Bid)', 'description': 'Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.'}], 'classes': [{'title': 'Epworth Sleepiness Scale at baseline', 'categories': [{'measurements': [{'value': '5.29', 'spread': '3.47', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '3.66', 'groupId': 'OG001'}, {'value': '5.78', 'spread': '3.74', 'groupId': 'OG002'}, {'value': '6.34', 'spread': '4.35', 'groupId': 'OG003'}]}]}, {'title': 'Epworth Sleepiness Scale at week 12', 'categories': [{'measurements': [{'value': '5.09', 'spread': '3.33', 'groupId': 'OG000'}, {'value': '6.58', 'spread': '3.62', 'groupId': 'OG001'}, {'value': '6.44', 'spread': '4.21', 'groupId': 'OG002'}, {'value': '7.52', 'spread': '5.03', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.014', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '1.14', 'ciLowerLimit': '0.23', 'ciUpperLimit': '2.04', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.03', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '1', 'ciLowerLimit': '0.094', 'ciUpperLimit': '1.9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0019', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '1.49', 'ciLowerLimit': '0.56', 'ciUpperLimit': '2.43', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to week 12', 'description': 'Total score ranges from zero (best) to 24 (worst); scale has 8 items, each rated from zero (no chance of dozing) to 3 (high chance of dozing)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Beck Depression Inventory II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'matching tablet'}, {'id': 'OG001', 'title': 'Mirapex (Pramipexole 0.5 mg Tid)', 'description': 'Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.'}, {'id': 'OG002', 'title': 'Mirapex (Pramipexole 0.5 mg Bid)', 'description': 'Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.'}, {'id': 'OG003', 'title': 'Mirapex (Pramipexole 0.75 mg Bid)', 'description': 'Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.'}], 'classes': [{'title': 'Beck Depression Inventory II at baseline', 'categories': [{'measurements': [{'value': '6.05', 'spread': '6.01', 'groupId': 'OG000'}, {'value': '6.66', 'spread': '5.36', 'groupId': 'OG001'}, {'value': '6.96', 'spread': '5.14', 'groupId': 'OG002'}, {'value': '7.4', 'spread': '5.87', 'groupId': 'OG003'}]}]}, {'title': 'Beck Depression Inventory II at week 12', 'categories': [{'measurements': [{'value': '5.92', 'spread': '5.83', 'groupId': 'OG000'}, {'value': '5.70', 'spread': '5.14', 'groupId': 'OG001'}, {'value': '5.97', 'spread': '5.14', 'groupId': 'OG002'}, {'value': '6.54', 'spread': '5.19', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.39', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.55', 'ciLowerLimit': '-1.82', 'ciUpperLimit': '0.71', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.37', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.57', 'ciLowerLimit': '-1.84', 'ciUpperLimit': '0.69', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.48', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.47', 'ciLowerLimit': '-1.78', 'ciUpperLimit': '0.84', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to week 12', 'description': 'Total score ranges from zero (best) to 63 (worst); scale has 21 items, each rated from zero (absent) to 3 (severe)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'matching tablet'}, {'id': 'FG001', 'title': 'Mirapex (Pramipexole 0.5 mg Tid)', 'description': 'Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.'}, {'id': 'FG002', 'title': 'Mirapex (Pramipexole 0.5 mg Bid)', 'description': 'Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.'}, {'id': 'FG003', 'title': 'Mirapex (Pramipexole 0.75 mg Bid)', 'description': 'Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '80'}, {'groupId': 'FG002', 'numSubjects': '81'}, {'groupId': 'FG003', 'numSubjects': '73'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '70'}, {'groupId': 'FG002', 'numSubjects': '70'}, {'groupId': 'FG003', 'numSubjects': '62'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Worsening of disease under study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Worsening of other pre-existing disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'There were 312 patients enrolled and 311 patients entered'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}, {'value': '311', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'matching tablet'}, {'id': 'BG001', 'title': 'Mirapex (Pramipexole 0.5 mg Tid)', 'description': 'Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.'}, {'id': 'BG002', 'title': 'Mirapex (Pramipexole 0.5 mg Bid)', 'description': 'Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.'}, {'id': 'BG003', 'title': 'Mirapex (Pramipexole 0.75 mg Bid)', 'description': 'Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.7', 'spread': '11', 'groupId': 'BG000'}, {'value': '63.7', 'spread': '9.8', 'groupId': 'BG001'}, {'value': '61.6', 'spread': '10.2', 'groupId': 'BG002'}, {'value': '63.1', 'spread': '9.9', 'groupId': 'BG003'}, {'value': '62.3', 'spread': '10.2', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '104', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '207', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 312}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'lastUpdateSubmitDate': '2014-05-07', 'studyFirstSubmitDate': '2006-11-19', 'resultsFirstSubmitDate': '2009-09-22', 'studyFirstSubmitQcDate': '2006-11-19', 'lastUpdatePostDateStruct': {'date': '2014-05-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-12-10', 'studyFirstPostDateStruct': {'date': '2006-11-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Unified Parkinson's Disease Rating Scale (UPDRS) Total Score", 'timeFrame': 'From baseline to week 12', 'description': 'Total score ranges from zero (best) to 176 (worst), as the sum of Parts I (Mental questions), II (Activity of Daily Living questions), and III (Motor examination)'}], 'secondaryOutcomes': [{'measure': 'Modified Hoehn and Yahr Stage', 'timeFrame': 'From baseline to week 12', 'description': 'Score ranges from best 0 (no signs of disease) to worst 5 (wheelchair bound or bedridden unless aided)'}, {'measure': 'Epworth Sleepiness Scale', 'timeFrame': 'From baseline to week 12', 'description': 'Total score ranges from zero (best) to 24 (worst); scale has 8 items, each rated from zero (no chance of dozing) to 3 (high chance of dozing)'}, {'measure': 'Beck Depression Inventory II', 'timeFrame': 'From baseline to week 12', 'description': 'Total score ranges from zero (best) to 63 (worst); scale has 21 items, each rated from zero (absent) to 3 (severe)'}]}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': 'Primary objective: to assess the efficacy of pramipexole given two times daily compared to placebo.\n\nSecondary objectives: to assess the effects of pramipexole on mood, cognition, fatigue, impulse control, daytime sleepiness and nighttime sleep compared to placebo; to compare the tolerability among the treatment groups over 12 weeks'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '31 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPotential subjects must meet all of the following inclusion criteria to be eligible for enrollment into this study:\n\n1. Must be willing and able to give informed consent.\n2. Must be over 30 years of age at Baseline.\n3. Must have idiopathic Parkinson's disease of less than 7 years duration since diagnosis, characterized by 2 of the following 3 cardinal signs (signs need to be asymmetric): resting tremor, bradykinesia and rigidity.\n4. Must have a Modified Hoehn and Yahr stage \\<3.\n5. Should be able to safely tolerate placebo for up to 12 weeks after Baseline.\n6. Must have a negative urine pregnancy test at the Screening Visit and use an adequate contraceptive method throughout the study if a woman of child-bearing potential. Women who are surgically sterile (hysterectomy or tubal ligation) or whose last menstruation was 12 months or more prior to the Screening Visit are considered to be of non-child-bearing potential. Acceptable forms of contraception include oral, implanted, or injected contraceptives intrauterine devices in place for at least 3 months estrogen patch and adequate barrier methods in conjunction with spermicide. Abstinence is considered an acceptable contraceptive regimen.\n7. Must be willing and able to comply with trial procedures. They must be sufficiently proficient in English to understand and complete study instruments.\n\nExclusion Criteria:\n\nIndividuals with any of the following characteristics will not be eligible for entry into this study:\n\n1. Signs or symptoms suggesting other parkinsonian syndromes.\n2. Use of medications that may cause secondary parkinsonism, including but not limited to: neuroleptics, metaclopramide, alphamethyldopa, flunarizine, methylphenidate, cinnarizine, reserpine, or amphetamines in the last 6 months prior to Baseline Visit.\n3. Use of dopaminergic medications within the last 3 months or for longer than 6 months prior to Baseline Visit.\n4. Presence of dementia by Diagnostic and Statistical Manual of Mental Disorders IV criteria (R06-1340) or a Mini Mental State Examination (R96-2656) (Appendix 10.1) score less than 26 at Screening Visit.\n5. Presence of major depression, as determined by medical history.\n6. Active epilepsy (i.e., occurrence of a seizure) within the past year prior to Baseline Visit.\n7. Electro Convulsive Therapy in previous 90 days prior to Baseline Visit.\n8. Myocardial infarction within previous 6 months prior to Baseline Visit.\n9. Third degree atrioventricular block or sick sinus syndrome.\n10. Congestive heart failure Class III or IV by New York Heart Association classification.\n11. Symptomatic orthostatic hypotension at Screening Visit.\n12. Stereotaxic brain surgery.\n13. Clinically significant liver disease.\n14. Clinically significant renal disease.\n15. Any other clinically significant medical or psychiatric condition (e.g., angina, active neoplasm) that in the judgment of the investigator would interfere with the subjects ability to participate in the study or would jeopardize safe conduct of the study.\n16. Breastfeeding.\n17. Known hypersensitivity or intolerability to pramipexole.\n18. Participating in other drug studies or receiving other experimental medications within 30 days of Baseline Visit.\n19. History of drug or alcohol dependency within 6 months of baseline visit."}, 'identificationModule': {'nctId': 'NCT00402233', 'briefTitle': "A Randomized, Double-blind, Active (Pramipexole 0.5 mg Tid) and Placebo Controlled, Study of Pramipexole Given 0.5 mg and 0.75 mg Bid Over 12-week Treatment in Early Parkinson's Disease (PD) Patients", 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': "A Randomized, Double-blind, Active (Pramipexole 0.5 mg Tid) and Placebo Controlled, Efficacy Study of Pramipexole Given 0.5 mg and 0.75 mg Bid Over a 12-week Treatment Phase in Early Parkinson's Disease Patients (PramiBID)", 'orgStudyIdInfo': {'id': '248.622'}, 'secondaryIdInfos': [{'id': 'PramiBID'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'OTHER', 'label': 'Pramipexole 0.5 mg Tid', 'description': 'Pramipexole 0.5 mg tid (three times a day)', 'interventionNames': ['Drug: Pramipexole']}, {'type': 'OTHER', 'label': 'Pramipexole 0.5 mg Bid', 'description': 'Pramipexole 0.5 mg bid (bis in die (two times a day))', 'interventionNames': ['Drug: Pramipexole']}, {'type': 'OTHER', 'label': 'Pramipexole 0.75 mg Bid', 'description': 'Pramipexole 0.75 mg bid (bis in die (two times a day))', 'interventionNames': ['Drug: Pramipexole']}], 'interventions': [{'name': 'Pramipexole', 'type': 'DRUG', 'armGroupLabels': ['Pramipexole 0.5 mg Bid', 'Pramipexole 0.5 mg Tid', 'Pramipexole 0.75 mg Bid']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': '248.622.170 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': '248.622.112 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 34.74648, 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