{ "FullStudy":{ "Rank":217897, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01515410", "OrgStudyIdInfo":{ "OrgStudyId":"81-0068" }, "Organization":{ "OrgFullName":"Depomed", "OrgClass":"INDUSTRY" }, "BriefTitle":"Study in Advanced Parkinson's Disease Patients With Predictable Motor Fluctuations", "OfficialTitle":"A Phase 2, Randomized, Open-Label, Crossover Study to Compare DM-1992, a Novel Gastric-Retentive Extended-Release Formulation of Levodopa/Carbidopa, to an Immediate-Release Carbidopa Tablet in Patients With Advanced Parkinson's Disease With Motor Fluctuations" }, "StatusModule":{ "StatusVerifiedDate":"November 2012", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"September 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"October 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 11, 2012", "StudyFirstSubmitQCDate":"January 23, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 24, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"November 20, 2013", "ResultsFirstSubmitQCDate":"January 27, 2014", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"March 10, 2014", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 27, 2014", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"March 10, 2014", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Depomed", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The primary objective of this study is to explore the efficacy and tolerability of DM-1992 compared to a standard carbidopa/Levodopa Immediate-Release (CD/LD IR) tablet (Sinemet IR) as measured by:\n\n\"ON\" time with no dyskinesia or non-troublesome dyskinesia\n\"OFF\" time" }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Parkinson's Disease", "Motor Fluctuations" ] }, "KeywordList":{ "Keyword":[ "Parkinson's disease", "PD", "stage2/3Parkinson's", "Advanced Parkinson's Disease with Motor Fluctuations" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Crossover Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"34", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"DM-1992", "ArmGroupType":"Experimental", "ArmGroupDescription":"DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD)", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: DM-1992" ] } },{ "ArmGroupLabel":"Sinemet IR", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"An Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD)", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Sinemet IR" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"DM-1992", "InterventionDescription":"72.5mg carbidopa/230mg levodopa", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "DM-1992" ] } },{ "InterventionType":"Drug", "InterventionName":"Sinemet IR", "InterventionDescription":"Immediate-release tablet containing 25mg carbidopa and 100mg levodopa", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Sinemet IR" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"The Primary Objective of This Study is to Explore the Efficacy and Tolerability of DM-1992 Compared to a Standard CD/LD IR Formulation as Measured by Percent \"OFF\" Time.", "PrimaryOutcomeDescription":"\"OFF\" indicates wearing off motor fluctuations before the next levodopa dose. Percent \"OFF\" time is calculated as the total \"OFF\" time divided by the total awake time for each day and multiplied by 100.\n\nPatient diary-every 30min while awake for 3days prior to initial Day1 as baseline & during the last 3days before Day10 for both treatments for dyskinesia state.\n\nBaseline is the average of the 3 days recorded in the patient diary prior to Day 1 of Period 1.\n\nEnd of Period is the average of the 3 days recorded in the patient diary prior to Day 10 in each period.\n\nClinician-Assess efficacy at pre-dose, every 30min for Day1 and hourly for Day10 for dyskinesia state & motor fluctuations at clinic visits.", "PrimaryOutcomeTimeFrame":"Baseline and 10 days for each of the 2 study periods" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nMen and women at least 30 years and older at the time of informed consent with advanced idiopathic Parkinson's disease with predictable wearing-off motor fluctuations with Hoehn and Yahr Stage II-III when \"on.\"\nPatients should be able to differentiate between the \"ON\" and \"OFF\" states with an average daily \"OFF\" time of ≥ 2.5 hours at study entry.\nOn a stable daily dose of LD of ≥ 400 mg but ≤1600 mg for at least 1 month prior to the screening visit.\nNon CD/LD containing anti-Parkinson's medications should be kept at stable doses for 1 month prior to screening visit. Patients should be willing to keep their non LD containing medications consistently throughout the study duration.\nFemale patients of childbearing potential should be abstinent or continuing to practice and willing to continue throughout the study with appropriate contraceptives (defined as Nova ring, oral, injected, transdermal patch, implanted, or barrier).\nMini Mental State Examination (MMSE) ≥ 26 at screening visit.\nAble to provide informed consent and willing to sign Health Insurance Portability and Accountability Act (HIPAA) authorization.\nAble and willing to comply with the protocol, including availability for all scheduled study visits and blood sample collections. Must be under the observation of a competent care giver throughout the study participation.\n\nExclusion Criteria:\n\nPatients with atypical or drug-induced Parkinson's disease.\nPatients with a known history of hypersensitivity to levodopa or carbidopa.\nPatients who receive treatments with dopamine receptor blocking agents\nPatients with a history of seizures except of childhood febrile seizure.\nPatients with dementia.\nPatients with a significant history of GI diseases (severe inflammatory bowel disease, irritable bowel disease, dyspepsia, gastro-esophageal reflux disease etc.) in the past five years.\nPatients with any history of gastric surgery other than vagotomy and pyloroplasty.\nPatients with an immune-compromised state.\nPatients with clinically significant hepatic insufficiency with Child-Pugh total score of ≥ 5.\nPatients with a calculated creatinine clearance (Clcr) < 50 mL/min using the Cockcroft-Gault equation.\nPatients who have a difficulty swallowing tablets.\nPatient has participated in a clinical trial of an investigational drug or device within 30 days of the screening visit.\nPatients with any other serious medical condition that, in the opinion of the Investigator would jeopardize the safety of the patient or affect the validity of the study results.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"30 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Rekha Sathyanarayana", "OverallOfficialAffiliation":"Depomed", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationCity":"Birmingham", "LocationState":"Alabama", "LocationCountry":"United States" },{ "LocationCity":"Little Rock", "LocationState":"Arkansas", "LocationCountry":"United States" },{ "LocationCity":"Long Beach", "LocationState":"California", "LocationCountry":"United States" },{ "LocationCity":"Chicago", "LocationState":"Illinois", "LocationCountry":"United States" },{ "LocationCity":"Bingham Farms", "LocationState":"Michigan", "LocationCountry":"United States" },{ "LocationCity":"Cincinnati", "LocationState":"Ohio", "LocationCountry":"United States" },{ "LocationCity":"Dallas", "LocationState":"Texas", "LocationCountry":"United States" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"A total of 34 subjects were randomly assigned to treatment in this crossover study: 19 in the DM-1992 for Period 1 and Sinemet IR for Period 2 sequence, and 15 in the Sinemet IR for Period 1 and DM-1992 for Period 2 sequence. All 34 subjects received study treatment and were included in the safety and intent-to-treat (ITT) populations.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"DM-1992 First, Then Sinemet IR", "FlowGroupDescription":"DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD) first, then Sinemet IR, an Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD)" },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Sinemet IR First, Then DM-1992", "FlowGroupDescription":"Sinemet IR, an Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD) first, then DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD)" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"19" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"15" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"19" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"15" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Overall Study", "BaselineGroupDescription":"DM-1992 first, then Sinemet IR; Sinemet IR first, then DM-1992" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"34" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"61.4", "BaselineMeasurementSpread":"8.41" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"8" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"26" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Race/Ethnicity, Customized", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"White", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"32" } ] } } ] } },{ "BaselineClassTitle":"Afro-Caribbean", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2" } ] } } ] } },{ "BaselineClassTitle":"Native Hawaiian or Other Pacific Islander", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" } ] } } ] } },{ "BaselineClassTitle":"Asian", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" } ] } } ] } },{ "BaselineClassTitle":"American Indian or Alaskan Native", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" } ] } } ] } },{ "BaselineClassTitle":"Hispanic or Latino", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" } ] } } ] } },{ "BaselineClassTitle":"Other", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Percent \"OFF\" Time (%)", "BaselineMeasureDescription":"Baseline is the average of the 3 days recorded in the patient diary prior to Day 1 of Period 1.", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"percentage of time", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"32.50", "BaselineMeasurementSpread":"9.962" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"The Primary Objective of This Study is to Explore the Efficacy and Tolerability of DM-1992 Compared to a Standard CD/LD IR Formulation as Measured by Percent \"OFF\" Time.", "OutcomeMeasureDescription":"\"OFF\" indicates wearing off motor fluctuations before the next levodopa dose. Percent \"OFF\" time is calculated as the total \"OFF\" time divided by the total awake time for each day and multiplied by 100.\n\nPatient diary-every 30min while awake for 3days prior to initial Day1 as baseline & during the last 3days before Day10 for both treatments for dyskinesia state.\n\nBaseline is the average of the 3 days recorded in the patient diary prior to Day 1 of Period 1.\n\nEnd of Period is the average of the 3 days recorded in the patient diary prior to Day 10 in each period.\n\nClinician-Assess efficacy at pre-dose, every 30min for Day1 and hourly for Day10 for dyskinesia state & motor fluctuations at clinic visits.", "OutcomeMeasurePopulationDescription":"Modified Intent-to-treat (ITT) Population", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of time", "OutcomeMeasureTimeFrame":"Baseline and 10 days for each of the 2 study periods", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"DM-1992", "OutcomeGroupDescription":"DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD)" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Sinemet IR", "OutcomeGroupDescription":"Sinemet IR, an Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD)" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"34" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"34" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-5.52", "OutcomeMeasurementLowerLimit":"-10.42", "OutcomeMeasurementUpperLimit":"-0.63" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.33", "OutcomeMeasurementLowerLimit":"-3.56", "OutcomeMeasurementUpperLimit":"6.22" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Percent \"OFF\" Time (%)", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0471", "OutcomeAnalysisPValueComment":"This p-value indicates statistical significance at the 0.05 level.", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisStatisticalComment":"No subjects early-terminated from the study.", "OutcomeAnalysisParamType":"Difference in Least Squares Mean", "OutcomeAnalysisParamValue":"-6.86", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCILowerLimit":"-13.62", "OutcomeAnalysisCIUpperLimit":"-0.09" } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventsTimeFrame":"Adverse events collected for a total of 5-6 weeks: from after signing the informed consent to the end of the study (Period 2, Day 10).", "EventsDescription":"Adverse event collection began after signing the informed consent and continued through Period 2, Day 10; serious adverse events followed for 30 days after study completion.", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"DM-1992", "EventGroupDescription":"DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD)", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"34", "EventGroupOtherNumAffected":"12", "EventGroupOtherNumAtRisk":"34" },{ "EventGroupId":"EG001", "EventGroupTitle":"Sinemet IR", "EventGroupDescription":"Sinemet IR, an Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD)", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"34", "EventGroupOtherNumAffected":"4", "EventGroupOtherNumAtRisk":"34" } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Abdominal Pain", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"2", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"34" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"34" } ] } },{ "OtherEventTerm":"Parkinsonian gait", "OtherEventOrganSystem":"Nervous system disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"3", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"34" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"2", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"34" } ] } },{ "OtherEventTerm":"Dizziness", "OtherEventOrganSystem":"Nervous system disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"3", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"34" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"34" } ] } },{ "OtherEventTerm":"Hypertonia", "OtherEventOrganSystem":"Nervous system disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"2", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"34" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"2", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"34" } ] } },{ "OtherEventTerm":"Headache", "OtherEventOrganSystem":"Nervous system disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"2", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"34" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"34" } ] } } ] } }, "MoreInfoModule":{ "CertainAgreement":{ "AgreementPISponsorEmployee":"No", "AgreementRestrictionType":"OTHER", "AgreementRestrictiveAgreement":"Yes", "AgreementOtherDetails":"The PI agrees that sponsor shall have the right to the first publication of the study results which is intended to be a joint, multi-center publication. Following the first publication, the PI may publish study data or results, provided however PI submits the proposed publication to sponsor for review at least 60 days prior to the date of the proposed publication. Sponsor may remove any information that is considered confidential and/or proprietary other than study data." }, "PointOfContact":{ "PointOfContactTitle":"Head of R&D", "PointOfContactOrganization":"Depomed", "PointOfContactEMail":"msweeney@depomed.com", "PointOfContactPhone":"510-744-8000" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"C000009265", "InterventionMeshTerm":"Carbidopa, levodopa drug combination" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000276", "InterventionAncestorTerm":"Adjuvants, Immunologic" },{ "InterventionAncestorId":"D000007155", "InterventionAncestorTerm":"Immunologic Factors" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000000978", "InterventionAncestorTerm":"Antiparkinson Agents" },{ "InterventionAncestorId":"D000018726", "InterventionAncestorTerm":"Anti-Dyskinesia Agents" },{ "InterventionAncestorId":"D000018491", "InterventionAncestorTerm":"Dopamine Agonists" },{ "InterventionAncestorId":"D000015259", "InterventionAncestorTerm":"Dopamine Agents" },{ "InterventionAncestorId":"D000018377", "InterventionAncestorTerm":"Neurotransmitter Agents" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M259040", "InterventionBrowseLeafName":"Carbidopa, levodopa drug combination", "InterventionBrowseLeafAsFound":"Sinemet", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M9565", "InterventionBrowseLeafName":"Levodopa", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M4071", "InterventionBrowseLeafName":"Carbidopa", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2209", "InterventionBrowseLeafName":"Adjuvants, Immunologic", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8784", "InterventionBrowseLeafName":"Immunologic Factors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2876", "InterventionBrowseLeafName":"Antiparkinson Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M6056", "InterventionBrowseLeafName":"Dopamine", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19179", "InterventionBrowseLeafName":"Dopamine Agonists", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M16545", "InterventionBrowseLeafName":"Dopamine Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19088", "InterventionBrowseLeafName":"Neurotransmitter Agents", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"AnDyAg", "InterventionBrowseBranchName":"Anti-Dyskinesia Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"CaAg", "InterventionBrowseBranchName":"Cardiotonic Agents" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000010300", "ConditionMeshTerm":"Parkinson Disease" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000020734", "ConditionAncestorTerm":"Parkinsonian Disorders" },{ "ConditionAncestorId":"D000001480", "ConditionAncestorTerm":"Basal Ganglia Diseases" },{ "ConditionAncestorId":"D000001927", "ConditionAncestorTerm":"Brain Diseases" },{ "ConditionAncestorId":"D000002493", "ConditionAncestorTerm":"Central Nervous System Diseases" },{ "ConditionAncestorId":"D000009422", "ConditionAncestorTerm":"Nervous System Diseases" },{ "ConditionAncestorId":"D000009069", "ConditionAncestorTerm":"Movement Disorders" },{ "ConditionAncestorId":"D000019636", "ConditionAncestorTerm":"Neurodegenerative Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M11796", "ConditionBrowseLeafName":"Parkinson Disease", "ConditionBrowseLeafAsFound":"Parkinson's Disease", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M21078", "ConditionBrowseLeafName":"Parkinsonian Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M24190", "ConditionBrowseLeafName":"Ganglion Cysts", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M14941", "ConditionBrowseLeafName":"Synovial Cyst", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3355", "ConditionBrowseLeafName":"Basal Ganglia Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3786", "ConditionBrowseLeafName":"Brain Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4325", "ConditionBrowseLeafName":"Central Nervous System Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10612", "ConditionBrowseLeafName":"Movement Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M20142", "ConditionBrowseLeafName":"Neurodegenerative Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC10", "ConditionBrowseBranchName":"Nervous System Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC04", "ConditionBrowseBranchName":"Cancers and Other Neoplasms" },{ "ConditionBrowseBranchAbbrev":"BC17", "ConditionBrowseBranchName":"Skin and Connective Tissue Diseases" } ] } } } } } }