Ignite Creation Date:
2025-12-25 @ 1:13 AM
Ignite Modification Date:
2025-12-25 @ 11:23 PM
Study NCT ID:
NCT01130493
Status:
COMPLETED
Last Update Posted:
2019-10-29
First Post:
2010-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066
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': 'C009265', 'term': 'carbidopa, levodopa drug combination'}, {'id': 'C481098', 'term': 'Stalevo'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Kaihong.Jiang@amneal.com', 'phone': '(908) 307-2234', 'title': 'Kaihong Jiang, Senior Director, Head of Biometrics', 'organization': 'Impax Laboratories, LLC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Dose Conversion', 'description': 'Participants were to be converted from stable doses of CLE to open-label IPX066 over a 6-week period', 'otherNumAtRisk': 91, 'otherNumAffected': 14, 'seriousNumAtRisk': 91, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'IPX066', 'description': 'Participants first received 2 weeks of IPX066 followed by an approximate 7-day washout period of IPX066 treatment followed by another 2 weeks of CLE.', 'otherNumAtRisk': 89, 'otherNumAffected': 13, 'seriousNumAtRisk': 89, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'CLE (Active Comparator)', 'description': 'Participants first received 2 weeks of CLE followed by an approximate 7-day washout period of IPX066 treatment followed by another 2 weeks of IPX066.', 'otherNumAtRisk': 88, 'otherNumAffected': 2, 'seriousNumAtRisk': 88, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Washout', 'description': 'Participants receive open-label IPX066 for 1 week', 'otherNumAtRisk': 89, 'otherNumAffected': 1, 'seriousNumAtRisk': 89, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper Respiratory Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Confusional State', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal Toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypercalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of "OFF" Time During Waking Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IPX066', 'description': 'Participants who received IPX066 in either Period 1 or Period 2'}, {'id': 'OG001', 'title': 'CLE (Active Comparator)', 'description': 'Participants who received CLE in either Period 1 or Period 2'}], 'classes': [{'categories': [{'measurements': [{'value': '23.98', 'spread': '16.242', 'groupId': 'OG000'}, {'value': '32.48', 'spread': '21.917', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 days of data immediately prior to the end of each 2 week treatment period', 'description': 'Using a Parkinson\'s disease diary, subjects recorded a state of "asleep", "OFF", "ON without dyskinesia," "ON with non-troublesome dyskinesia," or "ON with troublesome dyskinesia" every 30 minutes over a 24-hour day for the last 3 days of each double-blind crossover treatment period.\n\nMean percentage of "OFF" Time During Waking Hours was calculated. "Off" Time is Time when medication has worn off and is no longer providing benefit with regard to mobility, slowness, and stiffness.', 'unitOfMeasure': 'Percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed both treatment periods and completed PD diary for both Period 1 and Period 2'}, {'type': 'SECONDARY', 'title': 'Total "OFF" Time During Waking Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IPX066', 'description': 'Participants who received IPX066 in either Period 1 or Period 2'}, {'id': 'OG001', 'title': 'CLE (Active Comparator)', 'description': 'Participants who received CLE in either Period 1 or Period 2'}], 'classes': [{'categories': [{'measurements': [{'value': '3.82', 'spread': '2.558', 'groupId': 'OG000'}, {'value': '5.22', 'spread': '3.672', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 days of data immediately prior to the end of each 2 week treatment period', 'description': 'Using a Parkinson\'s disease diary, subjects recorded a state of "asleep", "OFF", "ON without dyskinesia," "ON with non-troublesome dyskinesia," or "ON with troublesome dyskinesia" every 30 minutes over a 24-hour day for the last 3 days of each double-blind crossover treatment period.\n\nMean Total "Off" Time During Waking Hours was calculated. "Off" Time is Time when medication has worn off and is no longer providing benefit with regard to mobility, slowness, and stiffness.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed both treatment periods and completed PD diary for both Period 1 and Period 2'}, {'type': 'SECONDARY', 'title': 'Total "On" With No Troublesome Dyskinesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IPX066', 'description': 'Participants who received IPX066 in either Period 1 or Period 2'}, {'id': 'OG001', 'title': 'CLE (Active Comparator)', 'description': 'Participants who received CLE in either Period 1 or Period 2'}], 'classes': [{'categories': [{'measurements': [{'value': '11.36', 'spread': '3.259', 'groupId': 'OG000'}, {'value': '9.98', 'spread': '3.764', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 days of data immediately prior to the end of each 2 week treatment period', 'description': 'Using a Parkinson\'s disease diary, subjects recorded a state of "asleep", "OFF", "ON without dyskinesia," "ON with non-troublesome dyskinesia," or "ON with troublesome dyskinesia" every 30 minutes over a 24-hour day for the last 3 days of each double-blind crossover treatment period.\n\nMean Total "On" with No Troublesome Dyskinesia was calculated. "On" Time is when medication is providing benefit with regard to mobility, slowness, and stiffness.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed both treatment periods and completed PD diary for both Period 1 and Period 2'}, {'type': 'SECONDARY', 'title': 'UPDRS Part II Plus Part III', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IPX066', 'description': 'Participants who received IPX066 in either Period 1 or Period 2'}, {'id': 'OG001', 'title': 'CLE (Active Comparator)', 'description': 'Participants who received CLE in either Period 1 or Period 2'}], 'classes': [{'categories': [{'measurements': [{'value': '29.3', 'spread': '15.02', 'groupId': 'OG000'}, {'value': '31.7', 'spread': '14.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of each double-blind treatment period.', 'description': "Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) and Part III (Motor Examination). Part II consists of 14 questions, each ranges from 0 (Normal/None) - 4 (Worst) with a total score of 0 - 72. Part III consists of 27 questions, each ranges from 0 (Normal/None) - 4 (Worst) with a total score of 0 - 108.\n\nThe UPDRS Part II Plus Part III scores ranged from 0 (no problems with daily living or mobility) to 180 (severe problems with daily living and mobility.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed both treatment periods'}, {'type': 'SECONDARY', 'title': 'Subject Preference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Number of Participants Who Preferred IPX066', 'description': 'Participants who completed both treatment periods and who had a preference for IPX066'}, {'id': 'OG001', 'title': 'Number of Participants Who Preferred CLE', 'description': 'Participants who completed both treatment periods and who had a preference for CLE'}, {'id': 'OG002', 'title': 'Number of Participants Who Had no Preference', 'description': 'Participants who completed both treatment periods and who did not indicate a preference for either treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'End of Study (week 11)', 'description': 'Subjects who completed both treatments were asked to indicate a preference for Treatment Period 1 or Treatment Period 2 or no preference. Preferences for a particular treatment period were mapped to the associated treatment and reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed both treatment periods'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IPX066 Conversion', 'description': 'All subjects were converted to IPX066 during an open-label period'}, {'id': 'FG001', 'title': 'IPX066-Open-label IPX066 Washout-CLE-OLE', 'description': 'IPX066 (Per Protocol: Part 1 Period 1), Open-label washout IPX066, CLE (Per Protocol: Part 1 Period 2), OLE (Per Protocol: Part 2)'}, {'id': 'FG002', 'title': 'CLE-Open Label IPX066 Washout-IPX066-OLE', 'description': 'CLE (Per Protocol: Part 1 Period 1), Open-label washout IPX066, IPX066 (Per Protocol: Part 1 Period 2), OLE (Per Protocol: Part 2)'}], 'periods': [{'title': 'Open-label Dose Conversion to IPX066', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'During the open-label dose conversion to IPX066, all subjects received IPX066', 'groupId': 'FG000', 'numSubjects': '110'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Diary imcomplete', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Part 1: Double-blind Treatment Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '91 subjects completed IPX066 dose conversion and were then randomized to the two treatment sequences', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': '48 were randomized to IPX066-CLE double-blind treatment sequence', 'groupId': 'FG001', 'numSubjects': '48'}, {'comment': '43 were randomized to CLE-IPX066 double-blind treatment sequence', 'groupId': 'FG002', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '46'}, {'groupId': 'FG002', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Part 1: Open-Label IPX066 Washout', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '46'}, {'groupId': 'FG002', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}, {'title': 'Part 1: Double-blind Treatment Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}, {'title': 'Part 2: OLE', 'milestones': [{'type': 'STARTED', 'comment': '10 subjects did not roll over to Part 2 (OLE) as it was optional. Reasons were not collected.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'All subjects received IPX066 during OLE', 'groupId': 'FG001', 'numSubjects': '39'}, {'comment': 'No subjects received CLE during OLE', 'groupId': 'FG002', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Date first patient enrolled: March 22, 2011 Date last patient completed: January 12, 2012', 'preAssignmentDetails': 'Following enrollment, all subjects were converted from stable doses of CLE to IPX066 prior to randomization. Following dose conversion, subjects were randomized into one of the two treatment sequences.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'Participants who were randomized to receive either IPX066 or IR CD-LD in Part 1 of the study and then IPX066 in Part 2 (open-label extension).'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.1', 'spread': '9.34', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '68', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '79', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '89', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Participants who completed the Dose Conversion period and were randomized into the double-blind crossover portion of the study.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'dispFirstSubmitDate': '2013-09-27', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-25', 'studyFirstSubmitDate': '2010-05-24', 'dispFirstSubmitQcDate': '2013-09-27', 'resultsFirstSubmitDate': '2016-08-03', 'studyFirstSubmitQcDate': '2010-05-24', 'dispFirstPostDateStruct': {'date': '2013-10-28', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-15', 'studyFirstPostDateStruct': {'date': '2010-05-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of "OFF" Time During Waking Hours', 'timeFrame': '3 days of data immediately prior to the end of each 2 week treatment period', 'description': 'Using a Parkinson\'s disease diary, subjects recorded a state of "asleep", "OFF", "ON without dyskinesia," "ON with non-troublesome dyskinesia," or "ON with troublesome dyskinesia" every 30 minutes over a 24-hour day for the last 3 days of each double-blind crossover treatment period.\n\nMean percentage of "OFF" Time During Waking Hours was calculated. "Off" Time is Time when medication has worn off and is no longer providing benefit with regard to mobility, slowness, and stiffness.'}], 'secondaryOutcomes': [{'measure': 'Total "OFF" Time During Waking Hours', 'timeFrame': '3 days of data immediately prior to the end of each 2 week treatment period', 'description': 'Using a Parkinson\'s disease diary, subjects recorded a state of "asleep", "OFF", "ON without dyskinesia," "ON with non-troublesome dyskinesia," or "ON with troublesome dyskinesia" every 30 minutes over a 24-hour day for the last 3 days of each double-blind crossover treatment period.\n\nMean Total "Off" Time During Waking Hours was calculated. "Off" Time is Time when medication has worn off and is no longer providing benefit with regard to mobility, slowness, and stiffness.'}, {'measure': 'Total "On" With No Troublesome Dyskinesia', 'timeFrame': '3 days of data immediately prior to the end of each 2 week treatment period', 'description': 'Using a Parkinson\'s disease diary, subjects recorded a state of "asleep", "OFF", "ON without dyskinesia," "ON with non-troublesome dyskinesia," or "ON with troublesome dyskinesia" every 30 minutes over a 24-hour day for the last 3 days of each double-blind crossover treatment period.\n\nMean Total "On" with No Troublesome Dyskinesia was calculated. "On" Time is when medication is providing benefit with regard to mobility, slowness, and stiffness.'}, {'measure': 'UPDRS Part II Plus Part III', 'timeFrame': 'End of each double-blind treatment period.', 'description': "Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) and Part III (Motor Examination). Part II consists of 14 questions, each ranges from 0 (Normal/None) - 4 (Worst) with a total score of 0 - 72. Part III consists of 27 questions, each ranges from 0 (Normal/None) - 4 (Worst) with a total score of 0 - 108.\n\nThe UPDRS Part II Plus Part III scores ranged from 0 (no problems with daily living or mobility) to 180 (severe problems with daily living and mobility."}, {'measure': 'Subject Preference', 'timeFrame': 'End of Study (week 11)', 'description': 'Subjects who completed both treatments were asked to indicate a preference for Treatment Period 1 or Treatment Period 2 or no preference. Preferences for a particular treatment period were mapped to the associated treatment and reported.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Parkinson's Disease"]}, 'referencesModule': {'references': [{'pmid': '30425824', 'type': 'DERIVED', 'citation': "Morgan JC, Dhall R, Rubens R, Khanna S, Gupta S. Dosing Patterns during Conversion to IPX066, Extended-Release Carbidopa-Levodopa (ER CD-LD), in Parkinson's Disease with Motor Fluctuations. Parkinsons Dis. 2018 Oct 22;2018:9763057. doi: 10.1155/2018/9763057. eCollection 2018."}]}, 'descriptionModule': {'briefSummary': "This is a study to compare the efficacy of IPX066 and CLE in subjects with advanced Parkinson's disease.", 'detailedDescription': 'This is a randomized, double-blind, double-dummy, 2 treatment, 2-period crossover study followed by an open-label extension study period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosed with idiopathic Parkinson\'s Disease (PD).\n2. At least 30 years old at the time of PD diagnosis.\n3. Currently being treated with carbidopa/levodopa/entacapone (CLE) and on a stable regimen of conventional LD for at least 4 weeks and:\n\n * Requiring a total daily levodopa (LD) dose of at least 400 mg\n * Having a minimum dosing frequency of four times per day.\n * Individual CD-LD or CLE doses that contain an LD dose which is a multiple of 50 mg.\n4. Able to differentiate "on" state from "off" state.\n5. Have predictable "off" periods.\n6. Amantadine, anticholinergics, selective monoamine oxidase (MAO) type B inhibitors (e.g., selegiline, rasagiline) or dopamine agonists are allowed as long as the doses and regimens have been stable for at least 4 weeks prior to Screening and the therapy is intended to be constant throughout the course of the study.\n7. Agrees to use a medically acceptable method of contraception throughout the study and for 1 month afterward.\n\nExclusion Criteria:\n\n1. Diagnosed with atypical Parkinsonism or any known secondary Parkinsonian syndrome.\n2. Nonresponsive to LD therapy.\n3. Prior functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation) or if such procedures are anticipated during study participation.\n4. Received within 4 weeks of Screening or planning to take during participation in the clinical study: any controlled-release LD product, tolcapone, apomorphine, nonselective MAO inhibitors, or antipsychotics including neuroleptic agents for the purpose of treating psychosis or bipolar disorder.\n5. Allergy or hypersensitivity to CD, LD, entacapone, riboflavin, Yellow Dye #5 (tartrazine), citrus fruit or grape juice.\n6. History of or currently active psychosis.\n7. Active or prior medical conditions such as peptic ulcers or prior surgical (e.g., bowel) procedures that would interfere with LD absorption.\n8. Active or history of narrow-angle glaucoma.\n9. History of malignant melanoma or a suspicious undiagnosed skin lesion.\n10. History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome or nontraumatic rhabdomyolysis.\n11. Received any investigational medications during the 4 weeks prior to Screening.\n12. Unable to swallow large pills (e.g., large vitamin pills).\n13. Pregnant or breastfeeding.\n14. Subjects who are unable to complete a symptom diary.'}, 'identificationModule': {'nctId': 'NCT01130493', 'briefTitle': 'A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066', 'organization': {'class': 'INDUSTRY', 'fullName': 'Impax Laboratories, LLC'}, 'officialTitle': "A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 in Advanced Parkinson's Disease", 'orgStudyIdInfo': {'id': 'IPX066-B09-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'IPX066-CLE-OLE', 'description': 'Dose conversion from CLE to IPX066, IPX066 (Part 1 Period 1), Open-label IPX066, CLE (Part 1 Period 2), OLE (Part 2)', 'interventionNames': ['Drug: IPX066', 'Drug: CLE']}, {'type': 'OTHER', 'label': 'CLE-IPX066-OLE', 'description': 'Dose conversion from CLE to IPX066, CLE (Part 1 Period 1), Open-label IPX066, IPX066 (Part 1 Period 2), OLE (Part 2)', 'interventionNames': ['Drug: IPX066', 'Drug: CLE']}], 'interventions': [{'name': 'IPX066', 'type': 'DRUG', 'otherNames': ['extended-release carbidopa-levodopa'], 'description': 'experimental product', 'armGroupLabels': ['CLE-IPX066-OLE', 'IPX066-CLE-OLE']}, {'name': 'CLE', 'type': 'DRUG', 'otherNames': ['carbidopa/levodopa/entacapone'], 'description': 'active comparator', 'armGroupLabels': ['CLE-IPX066-OLE', 'IPX066-CLE-OLE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Margolin Brain Institute', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '94085', 'city': 'Sunnyvale', 'state': 'California', 'country': 'United States', 'facility': "The Parkinson's Institute in Sunnyvale", 'geoPoint': {'lat': 37.36883, 'lon': -122.03635}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'UM Movement Disorders Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33980', 'city': 'Port Charlotte', 'state': 'Florida', 'country': 'United States', 'facility': 'Charlotte Neurological Services', 'geoPoint': {'lat': 26.97617, 'lon': -82.09064}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': "USF Parkinson's and Movement Disorders Center", 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '48025', 'city': 'Bingham Farms', 'state': 'Michigan', 'country': 'United States', 'facility': 'Quest Research Institute', 'geoPoint': {'lat': 42.51587, 'lon': -83.27326}}, {'zip': '89102', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'University Health Systems', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '11725', 'city': 'Commack', 'state': 'New York', 'country': 'United States', 'facility': "Parkinson's Disease and Movement Disorders Center of Long Island", 'geoPoint': {'lat': 40.84288, 'lon': -73.29289}}, {'zip': '12401', 'city': 'Kingston', 'state': 'New York', 'country': 'United States', 'facility': 'Kingston Neurological Associates', 'geoPoint': {'lat': 41.92704, 'lon': -73.99736}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Neurology, Inc', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '23456', 'city': 'Virginia Beach', 'state': 'Virginia', 'country': 'United States', 'facility': 'Sentara Neurological Associates', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}, {'zip': '98034', 'city': 'Kirkland', 'state': 'Washington', 'country': 'United States', 'facility': "Booth Gardner Parkinson's Care Center", 'geoPoint': {'lat': 47.68149, 'lon': -122.20874}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Hôpital Gabriel Montpied-Service de Neurologie A-', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '13385', 'city': 'Marseille', 'country': 'France', 'facility': 'Service de neurologie-Hôpital de la Timone-', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '28832', 'city': 'Achim', 'country': 'Germany', 'facility': 'Praxis für Neurologie, Psychiatrie und Psychotherapie Achim', 'geoPoint': {'lat': 53.01416, 'lon': 9.0263}}, {'zip': '44805', 'city': 'Bochum', 'country': 'Germany', 'facility': 'Praxis Dres. Bitter/Schumann', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '81675', 'city': 'München', 'country': 'Germany', 'facility': 'Klinikum rechts der Isar der Technischen Universität München', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '07646', 'city': 'Stadtroda', 'country': 'Germany', 'facility': 'Klinik für Neurologie, Stadtroda', 'geoPoint': {'lat': 50.85684, 'lon': 11.72677}}, {'zip': '89081', 'city': 'Ulm', 'country': 'Germany', 'facility': 'RKU, Neurologische Klinik der Universität Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': '36057', 'city': 'Arcugnano', 'country': 'Italy', 'facility': 'Casa di Cura Villa Margherita', 'geoPoint': {'lat': 45.49579, 'lon': 11.5477}}, {'zip': '03043', 'city': 'Cassino', 'country': 'Italy', 'facility': 'San Raffaele Cassino, San Raffaele Cassino,', 'geoPoint': {'lat': 41.48581, 'lon': 13.82835}}, {'zip': '66013', 'city': 'Chieti', 'country': 'Italy', 'facility': "Dipartimento di Oncologia e Neuroscienze, Università G. D'Annunzio", 'geoPoint': {'lat': 42.34827, 'lon': 14.16494}}, {'zip': '58100', 'city': 'Grosseto', 'country': 'Italy', 'facility': 'Ospedale della Misericordia', 'geoPoint': {'lat': 42.76296, 'lon': 11.10941}}, {'zip': '163', 'city': 'Roma', 'country': 'Italy', 'facility': 'IRCCS San Raffaele Pisana', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'overallOfficials': [{'name': 'Impax Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Impax Laboratories, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Impax Laboratories, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}