Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT00914602
Status:
COMPLETED
Last Update Posted:
2021-05-05
First Post:
2009-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Exploratory Study of XP21279 (With Lodosyn®) and Sinemet® in Parkinson's Disease Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D002230', 'term': 'Carbidopa'}], 'ancestors': [{'id': 'D008750', 'term': 'Methyldopa'}, {'id': 'D004295', 'term': 'Dihydroxyphenylalanine'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006834', 'term': 'Hydrazines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'dispFirstSubmitDate': '2011-05-11', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-30', 'studyFirstSubmitDate': '2009-06-03', 'dispFirstSubmitQcDate': '2011-05-11', 'studyFirstSubmitQcDate': '2009-06-04', 'dispFirstPostDateStruct': {'date': '2011-05-18', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "to assess the pharmacokinetics of XP21279 sustained release formulation [administered with Lodosyn® (carbidopa)] and Sinemet® tablets in subjects with Parkinson's disease.", 'timeFrame': '4 weeks', 'description': 'To establish a pharmacokinetic profile for XP21279'}, {'measure': "to assess the Pharmacodynamics of XP21279 sustained release formulation [administered with Lodosyn® (carbidopa)] and Sinemet® tablets in subjects with Parkinson's disease.", 'timeFrame': '4 weeks', 'description': 'Changes in The Brief Parkinsonism Rating Scale during treatment'}, {'measure': "to assess the safety of XP21279 sustained release formulation [administered with Lodosyn® (carbidopa)] and Sinemet® tablets in subjects with Parkinson's disease.", 'timeFrame': '4 weeks', 'description': 'Observe values and changes in clinical laboratory and vital sign parameters describe by time of collection for each treatment period.'}], 'secondaryOutcomes': [{'measure': 'the dose correspondence between XP21279 and Sinemet® will be explored to guide dose selection for future studies in the target population', 'timeFrame': '4 weeks', 'description': 'comparison of PK levels and doses.'}]}, 'conditionsModule': {'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "The purpose of the study is to assess the pharmacokinetics, pharmacodynamics, and safety of XP21279 sustained release formulation \\[administered with Lodosyn® (carbidopa)\\] and Sinemet® tablets in subjects with Parkinson's disease with Motor Fluctuations.", 'detailedDescription': "This is a Phase 1/Phase 2 multiple-dose, multi-center, open-label, two period sequential-treatment study in subjects with Parkinson's disease to assess the pharmacokinetics, pharmacodynamics, and safety of XP21279 sustained release formulation \\[administered with Lodosyn® (carbidopa)\\] and Sinemet® tablets in subjects with Parkinson's disease and to explore dose correspondence between XP21279 and Sinemet® to guide dose selection for future studies in the target population (subjects with Parkinson's disease with motor fluctuations on Sinemet®)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subjects with a clinical diagnosis of idiopathic Parkinson's disease, confirmed by the presence of at least two cardinal signs of the disease (resting tremor, bradykinesia, rigidity).\n2. Subjects must have predictable motor fluctuations of the wearing off type, defined by wearing off in at least 50% of inter-dose intervals between the first and the last daily doses as recorded on the on/off diary over 3 days (Days -4 to -2) in the Screening Period.\n3. Subjects must be on stable TID or QID Sinemet® or carbidopa/levodopa regimens from morning through early evening, with a total daily dose ranging from 400 mg to 1000 mg of levodopa, for at least 1 week prior to Screening.\n\nExclusion Criteria:\n\n1. History, signs, or symptoms suggesting the diagnosis of secondary or atypical Parkinsonism.\n2. Subject has greater than or equal to moderately disabling dyskinesias for greater than 25% of the waking day as assessed by a score of 2 or more on item 32 and a score of 2 or more on item 33 on the UPDRS at Screening.\n3. Subjects who are dosing with Sinemet® or carbidopa/levodopa during the night time.\n4. Subjects who have significant neurological symptoms not accounted for by Parkinson's disease.\n5. Subjects who are taking concomitantly COMT inhibitors (i.e., entacapone or tolcapone) or treated with Stalevo®, Sinemet® CR, or Madopar®/Prolopa® (levodopa/benserazide)."}, 'identificationModule': {'nctId': 'NCT00914602', 'briefTitle': "An Exploratory Study of XP21279 (With Lodosyn®) and Sinemet® in Parkinson's Disease Subjects", 'organization': {'class': 'INDUSTRY', 'fullName': 'XenoPort, Inc.'}, 'officialTitle': "An Exploratory Pharmacokinetic, Pharmacodynamic and Safety Study of XP21279 (With Lodosyn®) and Sinemet® in Parkinson's Disease Subjects With Motor Fluctuations", 'orgStudyIdInfo': {'id': 'XP-C-058'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment Period A', 'description': 'Treatment Period A: Sinemet® 25-100 treatment After screening all subjects will be placed on a fixed dosing Sinemet® time regimen for approximately 14 days.', 'interventionNames': ['Drug: Sinemet 25-100 Oral Tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Period B', 'description': 'Multiple-Dose XP21279 (with Lodosyn®) treatment. Upon completion of Sinemet® treatment eligible subjects will be placed on a fixed dosing time regimen of XP21279 (with Lodosyn®).', 'interventionNames': ['Drug: XP21279', 'Drug: Carbidopa Pill']}], 'interventions': [{'name': 'Sinemet 25-100 Oral Tablet', 'type': 'DRUG', 'otherNames': ['Carbidopa / Levodopa'], 'description': 'After screening all subjects will be placed on a fixed dosing Sinemet® time regimen for approximately 14 days.', 'armGroupLabels': ['Treatment Period A']}, {'name': 'XP21279', 'type': 'DRUG', 'otherNames': ['XP21279 sustained related'], 'description': 'Upon completion of Sinemet® treatment eligible subjects will be placed on a fixed dosing time regimen of XP21279 (with Lodosyn®).', 'armGroupLabels': ['Treatment Period B']}, {'name': 'Carbidopa Pill', 'type': 'DRUG', 'otherNames': ['Lodosyn'], 'armGroupLabels': ['Treatment Period B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'facility': 'XenoPort Investigational Site', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '48025', 'city': 'Bingham Farms', 'state': 'Michigan', 'country': 'United States', 'facility': 'XenoPort Investigational Site', 'geoPoint': {'lat': 42.51587, 'lon': -83.27326}}], 'overallOfficials': [{'name': 'Steve D Caras, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Arbor Pharma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'XenoPort, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}