Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2026-01-04 @ 1:33 PM
Study NCT ID:
NCT02271503
Status:
COMPLETED
Last Update Posted:
2019-11-06
First Post:
2014-10-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the PK and Pharmacodynamics of IPX203 in Patients With Advanced Parkinson's Disease
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'dispFirstSubmitDate': '2017-09-07', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-25', 'studyFirstSubmitDate': '2014-10-13', 'dispFirstSubmitQcDate': '2017-09-14', 'studyFirstSubmitQcDate': '2014-10-20', 'dispFirstPostDateStruct': {'date': '2017-09-20', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants with Adverse Events', 'timeFrame': 'Screening through end of study approximately 6 weeks per subject'}, {'measure': 'Maximum concentration (Cmax)', 'timeFrame': 'Up to 10 hours'}, {'measure': 'Area under the curve (AUC)', 'timeFrame': 'Up to 10 hours'}], 'primaryOutcomes': [{'measure': '"Off" time per the Assessment of Subject\'s Motor State', 'timeFrame': 'Up to 10 hours'}], 'secondaryOutcomes': [{'measure': 'Duration of effect estimated using the timepoint at which an improvement of at least 4 points in the MDS-UPDRS Part III score from predose is first observed and continuing until the timepoint at which the improvement is no longer observed', 'timeFrame': 'Up to 10 hours'}, {'measure': 'Change from predose value in the number of finger-taps at each timepoint', 'timeFrame': 'Up to 10 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "This is a randomized, open-label, rater-blinded, multicenter, 3-treatment, 3 period, single-dose crossover study. Approximately 51 qualified immediate-release (IR) CD-LD-experienced advanced Parkinson's disease patients will be randomized to 1 of 3 dosing sequences.\n\nObjectives:\n\n* Assess the pharmacodynamics and pharmacokinetics (PK) of IPX203 (carbidopa and levodopa) in subjects with advanced Parkinson's disease.\n* Characterize the safety of IPX203 in subjects with advanced Parkinson's disease.", 'detailedDescription': "IPX203 contains two different drugs called levodopa and carbidopa in one capsule.\n\n* levodopa turns into a material called 'dopamine' in your brain. The dopamine helps to improve the symptoms of your Parkinson's disease.\n* carbidopa belongs to a group of medicines called 'aromatic amino acid decarboxylase inhibitors'. It helps levodopa work more effectively by slowing the speed at which levodopa is broken down in your body."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMale or female subjects diagnosed with idiopathic PD with motor complications, who are currently being treated chronically with stable regimens of CD-LD.\n\nRequiring at least 400 mg but not more than 1600 mg LD per day during the waking hours; and at least 100 mg but not more than 250 mg LD from IR CD-LD for the first morning dose.\n\nDosing frequency of IR CD-LD of at least 4 times daily excluding nighttime dosing.\n\nHave an average of at least 2 hours per day "off" time during the waking hours and at least 1 hour "off" time per day, based on the PD diary collected for 3 consecutive days prior to Visit 1.\n\nExclusion criteria:\n\nHave used first morning dose of controlled-release (CR) CD-LD or Rytary for at least 4 weeks prior to Visit 1.\n\nFemale subjects who are currently breastfeeding or lactating.\n\nHad prior functional neurosurgical treatment for PD (ablation or deep brain stimulation) or if such procedure(s) are planned or anticipated during the study period.\n\nAllergic to study drugs\n\nHistory of medical conditions or of a prior surgical procedure that would interfere with LD absorption, such as gastrectomy or small-bowel resection.\n\nHistory of peptic ulcer disease or upper gastrointestinal hemorrhage.\n\nHistory of narrow angle glaucoma.\n\nHistory of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias; neuroleptic malignant syndrome; or nontraumatic rhabdomyolysis.\n\nHistory of psychosis.\n\nEmployees or family members of the Investigator, study site, or Sponsor.\n\nSubjects who, in the opinion of the clinical investigator, should not participate in the study.\n\nBased on clinical assessment, subject does not adequately comprehend the terminology needed to complete the PD diary.'}, 'identificationModule': {'nctId': 'NCT02271503', 'briefTitle': "A Study to Assess the PK and Pharmacodynamics of IPX203 in Patients With Advanced Parkinson's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Impax Laboratories, LLC'}, 'officialTitle': "A Study to Assess the Pharmacokinetics and Pharmacodynamics of a Single Dose of IPX203 in Patients With Advanced Parkinson's Disease", 'orgStudyIdInfo': {'id': 'IPX203-B14-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Sequence 1', 'description': 'Subject received a single dose of IPX203 180 mg and/or IPX203 270mg in Period 1, a single dose of CD-LD IR in Period 2, and a single dose of Rytary 145 mg and/or Rytary 195 mg in Period 3.', 'interventionNames': ['Drug: CD-LD IR', 'Drug: IPX203 180 mg', 'Drug: IPX203 270 mg', 'Drug: Rytary 195 mg', 'Drug: Rytary 145 mg']}, {'type': 'OTHER', 'label': 'Sequence 2', 'description': 'Subject received a single dose of a single dose of CD-LD IR in Period 1, a single dose of Rytary 145 mg and/or Rytary 195 mg in Period 2, and a single dose of IPX203 180 mg and/or IPX203 270mg in Period 3.', 'interventionNames': ['Drug: CD-LD IR', 'Drug: IPX203 180 mg', 'Drug: IPX203 270 mg', 'Drug: Rytary 195 mg', 'Drug: Rytary 145 mg']}, {'type': 'OTHER', 'label': 'Sequence 3', 'description': 'Subject received a single dose of a single dose of Rytary 145 mg and/or Rytary 195 mg in Period 1, a single dose of IPX203 180 mg and/or IPX203 270mg in Period 2, and a single dose of CD-LD IR in Period 3.', 'interventionNames': ['Drug: CD-LD IR', 'Drug: IPX203 180 mg', 'Drug: IPX203 270 mg', 'Drug: Rytary 195 mg', 'Drug: Rytary 145 mg']}], 'interventions': [{'name': 'CD-LD IR', 'type': 'DRUG', 'otherNames': ['Sinemet'], 'description': 'CD-LD IR containing 25 mg carbidopa and 100 mg levodopa', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3']}, {'name': 'IPX203 180 mg', 'type': 'DRUG', 'otherNames': ['CD-LD ER 180 mg'], 'description': 'IPX203 containing 45 mg carbidopa and180 mg levodopa', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3']}, {'name': 'IPX203 270 mg', 'type': 'DRUG', 'otherNames': ['CD-LD ER 270 mg'], 'description': 'IPX203 containing 67.5 mg carbidopa and 270 mg levodopa', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3']}, {'name': 'Rytary 195 mg', 'type': 'DRUG', 'description': 'Rytary 48.75Mg-195Mg Extended-Release Capsule', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3']}, {'name': 'Rytary 145 mg', 'type': 'DRUG', 'description': 'Rytary 36.25Mg-145Mg Extended-Release Capsule', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Muhammad Ali Movement Disorder Center (MAMDC)', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Clinical Trials, Inc.', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': "The Parkinson's and Movement Disorder Institute", 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': "Parkinson's Disease and Movement Disorders Center of Boca Raton", 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '34102', 'city': 'Naples', 'state': 'Florida', 'country': 'United States', 'facility': 'Collier Neurologic Specialists', 'geoPoint': {'lat': 26.14234, 'lon': -81.79596}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': "University of South Florida Parkinson's Disease and Movement Disorder Center", 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Regents University', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '48334', 'city': 'Farmington Hills', 'state': 'Michigan', 'country': 'United States', 'facility': 'QUEST Research Institute', 'geoPoint': {'lat': 42.48531, 'lon': -83.37716}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Movement Disorders Clinic', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Case Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '99202', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Premier Clinical Research', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}], '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'}}}}