Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-02-25 @ 11:04 PM
Study NCT ID:
NCT01968460
Status:
COMPLETED
Last Update Posted:
2023-04-07
First Post:
2013-10-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With 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': 'C031967', 'term': 'rasagiline'}], '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': 'pninit@pharma2b.com', 'phone': '+972 8 9472672', 'title': 'Pninit Litman study director', 'organization': 'Pharma 2B LTD'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '14 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'P2B001 Treatment A', 'description': 'Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily.\n\nP2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 37, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'P2B001 Treatment B', 'description': 'Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily\n\nP2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 20, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo once daily for 12 weeks.\n\nPlacebo: placebo', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 24, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'NAUSEA', 'notes': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'SOMNOLENCE', 'notes': 'SOMNOLENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'DIZZINESS', 'notes': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}], 'seriousEvents': [{'term': 'ACUTE MYOCARDIAL INFARCTION', 'notes': 'NON-ST ELEVATION MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total UPDRS I, II, III Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'P2B001 Treatment A', 'description': 'Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily.\n\nP2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily'}, {'id': 'OG001', 'title': 'P2B001 Treatment B', 'description': 'Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily\n\nP2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo once daily for 12 weeks.\n\nPlacebo: placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.97', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '-5.15', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '-1.31', 'spread': '0.88', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.67', 'ciLowerLimit': '-7.20', 'ciUpperLimit': '-2.13', 'pValueComment': 'The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.28', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0027', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.84', 'ciLowerLimit': '-6.32', 'ciUpperLimit': '-1.36', 'pValueComment': 'The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.25', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': "Change from baseline to final visit (week 12) in total UPDRS score (defined as sum of parts I, II and III, scores (0-176). UPDRS- Unified Parkinson's Disease Rating Scale, minimum value is 0 points and maximum value is 176.\n\nHigh score mean worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analyis'}, {'type': 'SECONDARY', 'title': 'UPDRS ADL (Part II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'P2B001 Treatment A', 'description': 'Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily.\n\nP2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily'}, {'id': 'OG001', 'title': 'P2B001 Treatment B', 'description': 'Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily\n\nP2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo once daily for 12 weeks.\n\nPlacebo: placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.49', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '-1.06', 'spread': '0.36', 'groupId': 'OG001'}, {'value': '0.36', 'spread': '0.39', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.85', 'ciLowerLimit': '-2.86', 'ciUpperLimit': '-0.84', 'pValueComment': 'The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.51', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.005', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.42', 'ciLowerLimit': '-2.41', 'ciUpperLimit': '0.44', 'pValueComment': 'The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.01', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': 'Change from baseline in individual UPDRS ADL (part II). Activity of daily Life UPDRS part II minimum is 0 point and max is 52 point (worse outcome)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis'}, {'type': 'SECONDARY', 'title': 'CGI-S', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'P2B001 Treatment A', 'description': 'Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily.\n\nP2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily'}, {'id': 'OG001', 'title': 'P2B001 Treatment B', 'description': 'Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily\n\nP2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo once daily for 12 weeks.\n\nPlacebo: placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0165', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.10', 'ciLowerLimit': '1.47', 'ciUpperLimit': '44.77', 'pValueComment': 'The overall significance level for this study was 5% using two-tailed tests.', 'groupDescription': 'A subject will be defined as a treatment responder in case that the improvement from baseline to the Week12 / Last Observed Value (LOV) in the CGI-S will be of 1 point or more. Baseline adjusted logistic regression (SAS® LOGISTIC procedure) stratified by GeoSite using the STRATA sub-command with the following effects: treatment group and baseline CGI-S measurement was used to test the between the active groups and placebo contrasts.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.111', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.23', 'ciLowerLimit': '0.72', 'ciUpperLimit': '24.90', 'pValueComment': 'The overall significance level for this study will be 5% using two-tailed tests.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.90', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': "Change from baseline in individual Clinical Global Impression - Severity. Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness (Parkinson's Disease) at the time of assessment relative to the clinician's past experience with patients who have the same diagnosis as one of the following:. 1 is normal and 7 is the most extremely ill patients. A subject defined as a treatment responder when the improvement from baseline to the Week12 / Last Observed Value (LOV) was of at least 1 point or more.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'UPDRS Motor (Part III)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'P2B001 Treatment A', 'description': 'Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily.\n\nP2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily'}, {'id': 'OG001', 'title': 'P2B001 Treatment B', 'description': 'Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily\n\nP2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo once daily for 12 weeks.\n\nPlacebo: placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.43', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '-3.95', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '-1.62', 'spread': '0.69', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0058', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.81', 'ciLowerLimit': '-4.80', 'ciUpperLimit': '-0.83', 'pValueComment': 'The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.00', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0191', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.32', 'ciLowerLimit': '-4.26', 'ciUpperLimit': '-0.39', 'pValueComment': 'The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.98', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': "Change from baseline in individual UPDRS motor (part III). UPDRS- Unified Parkinson's Disease Rating Scale, part III motor . min is 0 and Max is 108 (Worse outcome)", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT anlysis'}, {'type': 'SECONDARY', 'title': 'PDQ39', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'P2B001 Treatment A', 'description': 'Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily.\n\nP2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily'}, {'id': 'OG001', 'title': 'P2B001 Treatment B', 'description': 'Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily\n\nP2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo once daily for 12 weeks.\n\nPlacebo: placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.01', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '-2.19', 'spread': '0.88', 'groupId': 'OG001'}, {'value': '0.26', 'spread': '0.88', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0097', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.27', 'ciLowerLimit': '-5.72', 'ciUpperLimit': '-0.80', 'pValueComment': 'The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.24', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0509', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.45', 'ciLowerLimit': '-4.91', 'ciUpperLimit': '-0.012', 'pValueComment': 'The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.24', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 weeks', 'description': "Change from baseline in individual Parkinson's Disease Questionnaire - 39. Score 0-100 where 0 is indicative of no problem at all and 100 is the maximum level of problem.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'P2B001 Treatment A', 'description': 'Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily.\n\nP2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily'}, {'id': 'FG001', 'title': 'P2B001 Treatment B', 'description': 'Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily\n\nP2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo once daily for 12 weeks.\n\nPlacebo: placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '149', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'P2B001 Treatment A', 'description': 'Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily.\n\nP2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily'}, {'id': 'BG001', 'title': 'P2B001 Treatment B', 'description': 'Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily\n\nP2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg), : Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo once daily for 12 weeks.\n\nPlacebo: placebo'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '83', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62', 'spread': '8', 'groupId': 'BG000'}, {'value': '63', 'spread': '8', 'groupId': 'BG001'}, {'value': '64', 'spread': '7', 'groupId': 'BG002'}, {'value': '63', 'spread': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '136', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '126', 'groupId': 'BG003'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 149}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-15', 'studyFirstSubmitDate': '2013-10-15', 'resultsFirstSubmitDate': '2022-10-31', 'studyFirstSubmitQcDate': '2013-10-18', 'lastUpdatePostDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-15', 'studyFirstPostDateStruct': {'date': '2013-10-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total UPDRS I, II, III Scores', 'timeFrame': 'Week 12', 'description': "Change from baseline to final visit (week 12) in total UPDRS score (defined as sum of parts I, II and III, scores (0-176). UPDRS- Unified Parkinson's Disease Rating Scale, minimum value is 0 points and maximum value is 176.\n\nHigh score mean worse outcome."}], 'secondaryOutcomes': [{'measure': 'UPDRS ADL (Part II)', 'timeFrame': 'Week 12', 'description': 'Change from baseline in individual UPDRS ADL (part II). Activity of daily Life UPDRS part II minimum is 0 point and max is 52 point (worse outcome)'}, {'measure': 'CGI-S', 'timeFrame': '12 weeks', 'description': "Change from baseline in individual Clinical Global Impression - Severity. Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness (Parkinson's Disease) at the time of assessment relative to the clinician's past experience with patients who have the same diagnosis as one of the following:. 1 is normal and 7 is the most extremely ill patients. A subject defined as a treatment responder when the improvement from baseline to the Week12 / Last Observed Value (LOV) was of at least 1 point or more."}, {'measure': 'UPDRS Motor (Part III)', 'timeFrame': '12 weeks', 'description': "Change from baseline in individual UPDRS motor (part III). UPDRS- Unified Parkinson's Disease Rating Scale, part III motor . min is 0 and Max is 108 (Worse outcome)"}, {'measure': 'PDQ39', 'timeFrame': '12 weeks', 'description': "Change from baseline in individual Parkinson's Disease Questionnaire - 39. Score 0-100 where 0 is indicative of no problem at all and 100 is the maximum level of problem."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["Parkinson's Disease, Rasagiline, Pramipexole"], 'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "This study will evaluate an oral fixed-dose, once daily product that combines pramipexole and rasagiline for the treatment of early Parkinson's disease.\n\nAnimal studies support the therapeutic advantage of combining low doses of rasagiline and pramipexole and suggest further improvement when both are administered in a sustained fashion. Both rasagiline and pramipexole are well known marketed drugs for Parkinson's disease with a good safety profile. combining the drugs in low doses and controlled release may provide better symptom management than the existing drugs alone or together."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is male or female ≥35 years of age to ≤75 years of age at the time of enrollment.\n* Subject has idiopathic Parkinson's disease consistent with the UK Brain Bank Criteria; must have bradykinesia with sequence effect and rest tremor or prominent motor asymmetry.\n* Subject with disease duration no longer than 3 years and 0 months.\n* Subject has a Hoehn \\& Yahr (H\\&Y) stage score of \\< 3.\n* Subject has a MMSE score ≥ 26\n\nExclusion Criteria:\n\n* Subject has an atypical parkinsonian syndrome or secondary parkinsonism (e.g., due to drugs, metabolic neurogenetic disorders, encephalitis, cerebrovascular disease or degenerative disease).\n* Subject has a history of psychosis or hallucinations within the previous 12 months.\n* Subject who is taking anticholinergic drugs.\n* Subject has previous exposure to levodopa or a dopamine agonist for longer than 4 weeks; if previous exposure was less than 4 weeks then it must not be within 2 months prior to the baseline visit.\n* Subject has previous exposure to a MAO-B inhibitor for longer than 4 weeks; if previous exposure was less than 4 weeks then it must not be within 3 months prior to the baseline visit.\n* Subject who is taking MAO inhibitors, potent CYP1A2 inhibitors, e,g, Ciprofloxacin, Dextromethorphan or antitussive agent, analgesic agents such as tramadol, meperidine, methadone and propoxyphene, strong 3A4 inducers, e.g., St. John's Wort or cyclobenzaprine (tricyclic muscle relaxant), dopamine antagonists, such as the neuroleptics (phenothiazines, butyrophenones, thioxanthenes) or metoclopramide. Probenecid, cimetidine, ranitidine, diltiazem, verapamil and quinidine."}, 'identificationModule': {'nctId': 'NCT01968460', 'briefTitle': "Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Pharma Two B Ltd.'}, 'officialTitle': "A Phase 2B, Twelve-week Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study, To Determine the Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease", 'orgStudyIdInfo': {'id': 'P2B001/001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg),', 'description': 'Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily.', 'interventionNames': ['Drug: P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg),']}, {'type': 'EXPERIMENTAL', 'label': 'P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg),', 'description': 'Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily', 'interventionNames': ['Drug: P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg),']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo once daily for 12 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg),', 'type': 'DRUG', 'description': 'Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily', 'armGroupLabels': ['P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg),']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo', 'armGroupLabels': ['Placebo']}, {'name': 'P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg),', 'type': 'DRUG', 'description': 'Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily', 'armGroupLabels': ['P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg),']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'P2B001 Site Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'P2B001 Site Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'P2B001 Site Aurora', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'city': 'Manchester', 'state': 'Connecticut', 'country': 'United States', 'facility': 'P2B001 Manchester', 'geoPoint': {'lat': 41.77593, 'lon': -72.52148}}, {'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'P2B001 Site New Haven', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'P2B001 Site Boca Raton', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'city': 'Port Charlotte', 'state': 'Florida', 'country': 'United States', 'facility': 'P2B001 Site Port Charlotte', 'geoPoint': {'lat': 26.97617, 'lon': -82.09064}}, {'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'P2B001 Site Tampa', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'P2B001 Site Augusta', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'P2B001 site Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'P2B001 Site Kansas City', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'P2B001 Site Boston', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'West Bloomfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'P2B001 Site west Bloomfield', 'geoPoint': {'lat': 42.56891, 'lon': -83.38356}}, {'city': 'Golden Valley', 'state': 'Minnesota', 'country': 'United States', 'facility': 'P2B001 Site Golden Valley', 'geoPoint': {'lat': 45.00969, 'lon': -93.34912}}, {'city': 'Camden', 'state': 'New Jersey', 'country': 'United States', 'facility': 'P2B001 Site Camden', 'geoPoint': {'lat': 39.92595, 'lon': -75.11962}}, {'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'P2B001 Site New Brunswick', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'city': 'Commack', 'state': 'New York', 'country': 'United States', 'facility': 'P2B001 site Commack', 'geoPoint': {'lat': 40.84288, 'lon': -73.29289}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'P2B001 Site New York', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'P2B001 Site Durham', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'P2B001 Site Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'P2B001 Site Toledo', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'P2B001 Site Tulsa', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'P2B001 Site Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Roanoke', 'state': 'Virginia', 'country': 'United States', 'facility': 'P2B001 Site Roanoke', 'geoPoint': {'lat': 37.27097, 'lon': -79.94143}}, {'city': 'Haifa', 'country': 'Israel', 'facility': 'P2B001 Site Rambam Israel', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Pethch Tikva', 'country': 'Israel', 'facility': 'P2B001 Site Belinson'}, {'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'P2B001 Site Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'city': 'Rishon LeZiyyon', 'country': 'Israel', 'facility': 'P2B001 Site Asaf Harofe', 'geoPoint': {'lat': 31.97102, 'lon': 34.78939}}, {'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'P2B001 Site Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'overallOfficials': [{'name': 'pninit litman, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pharma Two B Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pharma Two B Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}