Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-02-24 @ 4:41 PM
Study NCT ID:
NCT00880620
Status:
COMPLETED
Last Update Posted:
2019-10-29
First Post:
2009-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With 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': 'C009265', 'term': 'carbidopa, levodopa drug combination'}]}}, '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': {'otherDetails': 'Publication of the results of the Study conducted at the Site shall not be made before the first multi-site publication by Sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '1 year, 6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo capsules were used', 'otherNumAtRisk': 92, 'otherNumAffected': 26, 'seriousNumAtRisk': 92, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'IPX066 145 mg LD', 'description': 'IPX066 capsules containing 145 mg levodopa and 36.25 mg carbidopa', 'otherNumAtRisk': 87, 'otherNumAffected': 27, 'seriousNumAtRisk': 87, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'IPX066 245 mg LD', 'description': 'IPX066 capsules containing 245 mg levodopa and 61.25 mg carbidopa', 'otherNumAtRisk': 104, 'otherNumAffected': 47, 'seriousNumAtRisk': 104, 'seriousNumAffected': 5}, {'id': 'EG003', 'title': 'IPX066 390 mg LD', 'description': 'IPX066 capsules containing 390 mg levodopa and 97.5 mg carbidopa', 'otherNumAtRisk': 98, 'otherNumAffected': 48, 'seriousNumAtRisk': 98, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 104, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 104, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 104, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 104, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Abnormal dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 104, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 104, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 104, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 104, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 104, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 104, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Orthostatic Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Abdominal strangulated hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Escherichia urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': "Non-Hodgkin's Lymphoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Coronary Artery Bypass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Prostatectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III at Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo capsules were used'}, {'id': 'OG001', 'title': 'IPX066 145mg LD', 'description': 'IPX066 capsules containing 145 mg levodopa and 36.25 mg carbidopa'}, {'id': 'OG002', 'title': 'IPX066 245 mg LD', 'description': 'IPX066 capsules containing 245 mg levodopa and 61.25 mg carbidopa'}, {'id': 'OG003', 'title': 'IPX066 390 mg LD', 'description': 'IPX066 capsules containing 390 mg levodopa and 97.5 mg carbidopa'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.6', 'spread': '10.37', 'groupId': 'OG000'}, {'value': '-11.7', 'spread': '10.97', 'groupId': 'OG001'}, {'value': '-12.9', 'spread': '11.42', 'groupId': 'OG002'}, {'value': '-14.9', 'spread': '11.85', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 30', 'description': "Analysis of the Change from Baseline in the sum of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) + UPDRS Part III (Motor Examination) at Week 30 (End of Study).\n\nUnified Parkinson's Disease Rating Scale (UPDRS) - Four Parts Higher score values represent a worse outcome.\n\nSubscales II and III were summed:\n\nPart I: Mentation, Behavior and Mood - 4 questions 1-4 Score range: 1-16 Part II: Activities of Daily Living - 13 questions 5-17 Score range: 0-52 Part III: Motor Examination - 19 questions 18-31 and 25 total assessments Score range: 0-100 Part IV: Complications of Therapy (In the past week) - 11 questions Score range: 0-25", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis included all treated subjects with at least one efficacy measurement after dosing. Subjects who had no post-baseline efficacy assessments (N4) and those who had early termination assessments\\>3 days after last dose and no other post-baseline measurements (N16) were not included in the efficacy analysis set. Randomized (381)-(4+16) = 361.'}, {'type': 'SECONDARY', 'title': "Summary of Change From Baseline to End of Study in Mean Parkinson's Disease Questionnaire-39 (PDQ-39) Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'IPX066 145 mg LD', 'description': 'IPX066 capsules containing 145 mg levodopa and 36.25 mg carbidopa'}, {'id': 'OG001', 'title': 'IPX066 245 mg LD', 'description': 'IPX066 capsules containing 245 mg levodopa and 61.25 mg carbidopa'}, {'id': 'OG002', 'title': 'IPX066 390 mg LD', 'description': 'IPX066 capsules containing 390 mg levodopa and 97.5 mg carbidopa'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo capsules were used'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.4', 'spread': '12.18', 'groupId': 'OG000'}, {'value': '-3.8', 'spread': '12.16', 'groupId': 'OG001'}, {'value': '-6.0', 'spread': '12.30', 'groupId': 'OG002'}, {'value': '0.6', 'spread': '11.10', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 30 (or End of Study)', 'description': 'Change from Baseline in Parkinson\'s disease Questionnaire 39 (PDQ-39) at Weeks 4, 9, 16, 23 and 30 or early discontinuation was collected. The PDQ-39 is a self-reported questionnaire consisting of 39 questions regarding the subjects mobility and the responses consist of "Never" (better in outcome), (value 0), "Occasionally" (value 1), "Sometimes" (value 2), , "Often" (value 3), and "Always" (value 4), (worse in outcome). The minimum possible score is "0" and the maximum is "156". The outcome measure calculated was the change from baseline to end of study in mean PDQ-39 score. Negative values indicate a better result.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who had no postbaseline efficacy assessments (N=4) and those who had early termination assessments \\>3 days after last dose and no other postbaseline measurements (N=16) were not included in the efficacy analysis. 2 subjects without a baseline measurement, 1 each from 145mg and 390mg arm were also excluded. Randomized 381-4-16-2=359.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo capsules were used'}, {'id': 'FG001', 'title': 'IPX066 145 mg LD', 'description': 'IPX066 capsule containing 145 mg levodopa and 36.25 mg carbidopa'}, {'id': 'FG002', 'title': 'IPX066 245 mg LD', 'description': 'IPX066 capsules containing 245 mg levodopa and 61.25 mg carbidopa'}, {'id': 'FG003', 'title': 'IPX066 390 mg LD', 'description': 'IPX066 capsules that contained 390 mg levodopa and 97.5 mg carbidopa'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Baseline', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '87'}, {'groupId': 'FG002', 'numSubjects': '104'}, {'groupId': 'FG003', 'numSubjects': '98'}]}, {'type': 'Week 4', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}, {'groupId': 'FG001', 'numSubjects': '79'}, {'groupId': 'FG002', 'numSubjects': '94'}, {'groupId': 'FG003', 'numSubjects': '86'}]}, {'type': 'Week 9', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '73'}, {'groupId': 'FG002', 'numSubjects': '88'}, {'groupId': 'FG003', 'numSubjects': '78'}]}, {'type': 'Week 16', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '73'}, {'groupId': 'FG002', 'numSubjects': '87'}, {'groupId': 'FG003', 'numSubjects': '74'}]}, {'type': 'Week 23', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '72'}, {'groupId': 'FG002', 'numSubjects': '85'}, {'groupId': 'FG003', 'numSubjects': '74'}]}, {'type': 'COMPLETED', 'comment': 'Week 30', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '72'}, {'groupId': 'FG002', 'numSubjects': '83'}, {'groupId': 'FG003', 'numSubjects': '74'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '15'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'First patient enrolled: 4/13/2009 Last patient out 10/05/2010', 'preAssignmentDetails': 'Following enrollment, subjects were randomized into one of the four treatment groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}, {'value': '98', 'groupId': 'BG003'}, {'value': '381', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo capsules were used'}, {'id': 'BG001', 'title': 'IPX066 145 mg LD', 'description': 'IPX066 capsules containing 145 mg levodopa and 36.25 mg carbidopa'}, {'id': 'BG002', 'title': 'IPX066 245 mg LD', 'description': 'IPX066 capsules containing 245 mg levodopa and 61.25 mg carbidopa'}, {'id': 'BG003', 'title': 'IPX066 390 mg LD', 'description': 'IPX066 capsules containing 390 mg levodopa and 97.5 mg carbidopa'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.4', 'spread': '9.43', 'groupId': 'BG000'}, {'value': '63.8', 'spread': '9.81', 'groupId': 'BG001'}, {'value': '65.2', 'spread': '9.73', 'groupId': 'BG002'}, {'value': '64.8', 'spread': '9.32', 'groupId': 'BG003'}, {'value': '64.8', 'spread': '9.55', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}, {'value': '169', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}, {'value': '212', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}, {'value': '345', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}, {'value': '96', 'groupId': 'BG003'}, {'value': '375', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}]}]}, {'title': 'Latvia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '134', 'groupId': 'BG004'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '115', 'groupId': 'BG004'}]}]}, {'title': 'Lithuania', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}]}]}, {'title': 'Estonia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': "Age at Parkinson's disease onset", 'classes': [{'categories': [{'measurements': [{'value': '63.7', 'spread': '9.48', 'groupId': 'BG000'}, {'value': '61.7', 'spread': '10.71', 'groupId': 'BG001'}, {'value': '63.6', 'spread': '10.43', 'groupId': 'BG002'}, {'value': '63.0', 'spread': '9.38', 'groupId': 'BG003'}, {'value': '63.0', 'spread': '10.00', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Duration of Parkinson's disease", 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '2.01', 'groupId': 'BG000'}, {'value': '2.3', 'spread': '3.08', 'groupId': 'BG001'}, {'value': '1.8', 'spread': '1.85', 'groupId': 'BG002'}, {'value': '2.0', 'spread': '2.33', 'groupId': 'BG003'}, {'value': '2.0', 'spread': '2.34', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'UPDRS Parts II and III Score', 'classes': [{'categories': [{'measurements': [{'value': '36.3', 'spread': '11.89', 'groupId': 'BG000'}, {'value': '36.1', 'spread': '13.56', 'groupId': 'BG001'}, {'value': '38.1', 'spread': '15.63', 'groupId': 'BG002'}, {'value': '36.3', 'spread': '13.04', 'groupId': 'BG003'}, {'value': '36.7', 'spread': '13.63', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': "Unified Parkinson's Disease Rating Scale (UPDRS) - Four Parts Higher score values represent a worse outcome.\n\nSubscales II and III were summed:\n\nPart I: Mentation, Behavior and Mood - 4 questions 1-4 Score range: 1-16 Part II: Activities of Daily Living - 13 questions 5-17 Score range: 0-52 Part III: Motor Examination - 19 questions 18-31 and 25 total assessments Score range: 0-100 Part IV: Complications of Therapy (In the past week) - 11 questions Score range: 0-25", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hoehn and Yahr Stage', 'classes': [{'title': 'Stage I', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}]}, {'title': 'Stage II', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}, {'value': '258', 'groupId': 'BG004'}]}]}, {'title': 'Remaining', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '83', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': "Hoehn and Yahr Staging of Parkinson's Disease: Stages move from 1 - 5 with the worse outcome stage being Stage 5.\n\nStage 1 = Symptoms on one side of the body only. Stage 2 = Symptoms on both sides of the body, No impairment of balance. Stage 3 = Balance impairment. Mild to moderate disease. Physically independent. Stage 4 = Severe disability but still able to walk or stand unassisted. Stage 5 = Wheelchair bound or bedridden unless assisted.", 'unitOfMeasure': 'units on a scale'}, {'title': 'MMSE', 'classes': [{'categories': [{'measurements': [{'value': '28.9', 'spread': '1.18', 'groupId': 'BG000'}, {'value': '29.0', 'spread': '1.27', 'groupId': 'BG001'}, {'value': '28.7', 'spread': '1.21', 'groupId': 'BG002'}, {'value': '28.9', 'spread': '1.18', 'groupId': 'BG003'}, {'value': '28.9', 'spread': '1.21', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The Mini-Mental State Examination (MMSE) is a 30-point questionnaire that is used extensively to measure cognitive impairment. Any score greater than or equal to 24 points (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Baseline Analysis Population is all treated'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 381}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'dispFirstSubmitDate': '2013-09-27', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-25', 'studyFirstSubmitDate': '2009-04-03', 'dispFirstSubmitQcDate': '2013-09-27', 'resultsFirstSubmitDate': '2015-12-07', 'studyFirstSubmitQcDate': '2009-04-13', 'dispFirstPostDateStruct': {'date': '2013-10-28', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-01-25', 'studyFirstPostDateStruct': {'date': '2009-04-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III at Week 30', 'timeFrame': 'Week 30', 'description': "Analysis of the Change from Baseline in the sum of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) + UPDRS Part III (Motor Examination) at Week 30 (End of Study).\n\nUnified Parkinson's Disease Rating Scale (UPDRS) - Four Parts Higher score values represent a worse outcome.\n\nSubscales II and III were summed:\n\nPart I: Mentation, Behavior and Mood - 4 questions 1-4 Score range: 1-16 Part II: Activities of Daily Living - 13 questions 5-17 Score range: 0-52 Part III: Motor Examination - 19 questions 18-31 and 25 total assessments Score range: 0-100 Part IV: Complications of Therapy (In the past week) - 11 questions Score range: 0-25"}], 'secondaryOutcomes': [{'measure': "Summary of Change From Baseline to End of Study in Mean Parkinson's Disease Questionnaire-39 (PDQ-39) Score", 'timeFrame': 'Baseline and Week 30 (or End of Study)', 'description': 'Change from Baseline in Parkinson\'s disease Questionnaire 39 (PDQ-39) at Weeks 4, 9, 16, 23 and 30 or early discontinuation was collected. The PDQ-39 is a self-reported questionnaire consisting of 39 questions regarding the subjects mobility and the responses consist of "Never" (better in outcome), (value 0), "Occasionally" (value 1), "Sometimes" (value 2), , "Often" (value 3), and "Always" (value 4), (worse in outcome). The minimum possible score is "0" and the maximum is "156". The outcome measure calculated was the change from baseline to end of study in mean PDQ-39 score. Negative values indicate a better result.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Parkinson's disease"], 'conditions': ["Parkinson's Disease"]}, 'referencesModule': {'references': [{'pmid': '24055014', 'type': 'BACKGROUND', 'citation': "Pahwa R, Lyons KE, Hauser RA, Fahn S, Jankovic J, Pourcher E, Hsu A, O'Connell M, Kell S, Gupta S; APEX-PD Investigators. Randomized trial of IPX066, carbidopa/levodopa extended release, in early Parkinson's disease. Parkinsonism Relat Disord. 2014 Feb;20(2):142-8. doi: 10.1016/j.parkreldis.2013.08.017. Epub 2013 Sep 5."}]}, 'descriptionModule': {'briefSummary': "This study examines the efficacy of three doses of IPX066 as compared to placebo in Parkinson's disease.", 'detailedDescription': "A randomized, double-blind, placebo-controlled, fixed-dose, parallel-arm study of three doses of IPX066 versus placebo.\n\nTotal of 427 subjects were screened and 381 were randomized and received one of the four treatment groups (1) placebo (N=92), (2) IPX066 145 mg LD (N=87) (3) IPX066 245 mg LD (N=104) (4) IPX066 390 mg LD (N=98) three times a day.\n\nStudy duration is approximately 30 weeks for each subject including 4 weeks of titration (up to 3 weeks of dose escalation and I week of stabilization for safe escalation to the allocated dose), and 26 weeks of maintenance.\n\nDuring the titration phase:\n\nThe following dose strengths were used to titrate up to the final three strengths that were assigned to the three IPX066 treatment arms.\n\nIPX066 95 mg LD capsule containing 95 mg LD and 23.75 mg CD. IPX066 145 mg LD capsule containing 145 mg LD and 36.25 mg CD. IPX066 195 mg LD capsule containing 195 mg LD and 48.75 mg CD. IPX066 245 mg LD capsule containing 245 mg LD and 61.25 mg CD.\n\nDuring the maintenance phase:\n\nIPX066 145 mg LD treatment arm received 145 mg LD and 36.25 mg CD. IPX066 245 mg LD treatment arm received 245 mg LD and 61.25 mg CD. IPX066 390 mg LD treatment arm received 390 mg LD and 97.50 mg CD.\n\nPrimary efficacy outcome measure was change from baseline in the sum of UPDRS Part II and Part III scores at the end of study or last value reported if subject discontinued prematurely.\n\nSummary of Change From Baseline to End of Study in Mean Parkinson's Disease Questionnaire-39 (PDQ-39) Score."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Able to understand and willing to voluntarily sign an informed consent form (ICF) and Health Insurance Portability and Accountability Act (HIPAA) authorization or local equivalent if applicable.\n2. Diagnosed with idiopathic PD.\n3. LD-naïve: defined as subjects not exposed to LD or catechol-O-methyl transferase inhibitors for more than 30 days and the exposure is not within 4 weeks prior to study enrollment.\n4. If currently taking anticholinergic therapy, amantadine, or a monoamine oxidase type B (MAO-B) inhibitor, maintains a stable regimen for at least 4 weeks prior to Baseline, and agrees to maintain the stable regimen throughout study participation.\n5. Agrees to use a medically acceptable method of contraception throughout the study and for 1 month after completing the study.\n6. Able and willing to comply with the protocol, including availability for all scheduled clinic visits and telephone calls.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding.\n2. Diagnosed with atypical Parkinsonism or any known secondary parkinsonian syndrome.\n3. Prior functional neurosurgical treatment for PD or if such procedures are anticipated during study participation.\n4. Use of nonselective MAO inhibitors.\n5. Use of dopamine agonists within 30 days prior to Screening.\n6. Unable to tolerate a placebo regimen, in the Investigator's opinion.\n7. Treatment of psychosis with any antipsychotic.\n8. History of seizure or epilepsy.\n9. Active or prior medical condition or prior surgical procedure that would interfere with LD absorption.\n10. History of narrow-angle glaucoma.\n11. Subjects with a history of malignant melanoma.\n12. History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome.\n13. Received any investigational medications during the 30 days prior to Screening."}, 'identificationModule': {'nctId': 'NCT00880620', 'acronym': 'APEX-PD', 'briefTitle': "A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Impax Laboratories, LLC'}, 'officialTitle': "A Placebo-Controlled Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease", 'orgStudyIdInfo': {'id': 'IPX066-B08-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'One Placebo capsule was given TID for the first 21 days. Two placebo capsules were given TID on days 22 till end of study (week 30).', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'IPX066 145 mg LD', 'description': 'One IPX066 95 mg LD was given TID on days 1-3. One IPX066 145 mg LD was given TID on days 4-21. One IPX066 145 mg LD and one placebo capsule were given TID on days 22 till end of study (week 30).', 'interventionNames': ['Drug: Placebo', 'Drug: IPX066 95 mg LD', 'Drug: IPX066 145 mg LD']}, {'type': 'EXPERIMENTAL', 'label': 'IPX066 245 mg LD', 'description': 'One IPX066 95 mg LD was given TID on days 1-3. One IPX066 145 mg LD was given TID on days 4-7. One IPX066 195 mg LD was given TID on days 8-14. One IPX066 245 mg LD was given TID on days 15-21. One IPX066 245 mg LD and one placebo capsule were given TID on days 22 till end of study (week 30).', 'interventionNames': ['Drug: Placebo', 'Drug: IPX066 95 mg LD', 'Drug: IPX066 145 mg LD', 'Drug: IPX066 195 mg LD', 'Drug: IPX066 245 mg LD']}, {'type': 'EXPERIMENTAL', 'label': 'IPX066 390 mg LD', 'description': 'One IPX066 95 mg LD was given TID on days 1-3. One IPX066 145 mg LD was given TID on days 4-7. One IPX066 195 mg LD was given TID on days 8-14. One IPX066 245 mg LD was given TID on days 15-21. Two IPX066 195 mg LD capsules were given TID on days 22 till end of study (week 30).', 'interventionNames': ['Drug: IPX066 95 mg LD', 'Drug: IPX066 145 mg LD', 'Drug: IPX066 195 mg LD', 'Drug: IPX066 245 mg LD']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['IPX066 145 mg LD', 'IPX066 245 mg LD', 'Placebo']}, {'name': 'IPX066 95 mg LD', 'type': 'DRUG', 'otherNames': ['CD-LD ER 95 mg'], 'description': 'IPX066 capsule containing 95 mg LD/23.75 mg CD', 'armGroupLabels': ['IPX066 145 mg LD', 'IPX066 245 mg LD', 'IPX066 390 mg LD']}, {'name': 'IPX066 145 mg LD', 'type': 'DRUG', 'otherNames': ['CD-LD ER 145 mg'], 'description': 'IPX066 capsule containing 145 mg LD/36.25 mg CD', 'armGroupLabels': ['IPX066 145 mg LD', 'IPX066 245 mg LD', 'IPX066 390 mg LD']}, {'name': 'IPX066 195 mg LD', 'type': 'DRUG', 'otherNames': ['CD-LD ER 195 mg'], 'description': 'IPX066 capsule containing 195 mg LD/48.75 mg CD', 'armGroupLabels': ['IPX066 245 mg LD', 'IPX066 390 mg LD']}, {'name': 'IPX066 245 mg LD', 'type': 'DRUG', 'otherNames': ['CD-LD ER 245 mg'], 'description': 'IPX066 capsule containing 245 mg LD/61.25 mg CD', 'armGroupLabels': ['IPX066 245 mg LD', 'IPX066 390 mg LD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham, Dept. of Neurology', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85050', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'HOPE Research Institute, LLC', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92845', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Collaborative NeuroScience Network, Inc.', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Coastal Neurological Medical Group', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Coordinated Clinical Research', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '94085', 'city': 'Sunnyvale', 'state': 'California', 'country': 'United States', 'facility': "The Parkinson's Institute", 'geoPoint': {'lat': 37.36883, 'lon': -122.03635}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Neurology Clinics, Temple Medical Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '34205', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Bradenton Research Center, Inc.', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '23021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Sunrise Clinical Research, Inc.', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '34471', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Renstar Medical Research', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '33952', 'city': 'Port Charlotte', 'state': 'Florida', 'country': 'United States', 'facility': 'Charlotte Neurological Services', 'geoPoint': {'lat': 26.97617, 'lon': -82.09064}}, {'zip': '33713', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Suncoast Neuroscience Associates, Inc.', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '83702', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Idaho Elks Rehabilitation Hospital', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 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