{
  "FullStudy":{
    "Rank":217869,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01515774",
          "OrgStudyIdInfo":{
            "OrgStudyId":"H-1104-062-358"
          },
          "Organization":{
            "OrgFullName":"Seoul National University Hospital",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Study to Observe the Effect of Mirapex ER® Once-daily (QD) Versus Twice-daily (BID)",
          "OfficialTitle":"An Open-label, Randomized, Multi-center, Crossover Study to Observe the Effect of Once-daily Mirapex ER® and Twice-daily Mirapex ER® in Patients With Parkinson Disease"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Unknown status",
          "LastKnownStatus":"Recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"September 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"August 2012",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"October 2012",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 10, 2012",
          "StudyFirstSubmitQCDate":"January 18, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 24, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 18, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 24, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"BS Jeon",
            "ResponsiblePartyInvestigatorTitle":"Professor",
            "ResponsiblePartyInvestigatorAffiliation":"Seoul National University Hospital"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Seoul National University Hospital",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"In order to observe the benefit, side effects, and patient preference of Mirapex ER when used in once-daily (QD) or twice-daily (BID) dosing\nIn order to estimate the conversion rate of dopamine agonists into Mirapex ER",
          "DetailedDescription":"Study subjects : Parkinson disease who are on Requip or Mirapex and are considering to change into Mirapex ER\n\nCross over study design:\n\nGroup 1: Once daily dose for 2 month then into BID in divided dose for 2 months\nGroup 2: BID in divided dose for 2 months then into QD dose for 2 months\nDose adjustment may be done in the first 4 weeks.\nCompare the benefit, side effects, and patient preference between the QD vs BID dosing"
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Parkinson's Disease"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Parkinson's disease",
              "Pramipexole"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 4"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Non-Randomized",
            "DesignInterventionModel":"Crossover Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"200",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Group 1",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Give QD dose first then BID dosing",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Mirapex ER"
                  ]
                }
              },{
                "ArmGroupLabel":"Group 2",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Give BID dosing and then QD dosing",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Mirapex ER"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Mirapex ER",
                "InterventionDescription":"Change Requip or Mirapex to Mirapex ER",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Group 1",
                    "Group 2"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Patient preference",
                "PrimaryOutcomeDescription":"Overall preference in QD versus BID",
                "PrimaryOutcomeTimeFrame":"4 months"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Motor complications",
                "SecondaryOutcomeDescription":"Visual rating scale for off severity, dyskinesia severity Duration - off duration, dyskinesia duration",
                "SecondaryOutcomeTimeFrame":"2 months at each arm"
              },{
                "SecondaryOutcomeMeasure":"Sleep problems",
                "SecondaryOutcomeDescription":"Parkinson's disease sleep scale (PDSS) Excessive daytime sleepiness scale(ESS)",
                "SecondaryOutcomeTimeFrame":"2 months at each arm"
              },{
                "SecondaryOutcomeMeasure":"Motor UPDRS and HY stage",
                "SecondaryOutcomeTimeFrame":"2months at each arm"
              },{
                "SecondaryOutcomeMeasure":"Side effects",
                "SecondaryOutcomeDescription":"Rating scale (0~10): Nausea, Dizziness, Somnolence, Headache, Constipation, Dyspepsia, Fatigue, Hallucination, Edema, Dry mouth,Others",
                "SecondaryOutcomeTimeFrame":"2 months at each arm"
              },{
                "SecondaryOutcomeMeasure":"Patient global impression for improvement",
                "SecondaryOutcomeTimeFrame":"2 months at each arm"
              },{
                "SecondaryOutcomeMeasure":"Preference in each factor",
                "SecondaryOutcomeDescription":"Preference of QD versus BID in each factor: off duration, off severity, dyskinesia duration, dyskinesia severity, on quality, adverse events, sleep quality, convenience",
                "SecondaryOutcomeTimeFrame":"4 months"
              },{
                "SecondaryOutcomeMeasure":"Patient choice",
                "SecondaryOutcomeDescription":"Patient choice in QD or BID Reason for the choice",
                "SecondaryOutcomeTimeFrame":"4 months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nAge: 30-80\nParkinson disease\nOn dopamine agonists (Requip or Mirapex) and are considering to change into Mirapex ER\nOn stable antiparkinsonian medication for at least 4 weeks\nWho signed consent to the study\n\nExclusion Criteria:\n\nWho are on less than 2 mg of Requip or 0.375 mg of Mirapex\nWho have dementia, psychosis, major depression and other serious neurological or medical problems\nWho are allergic to the similar medications\nWho has history of heavy metal poisoning\nWho were on othe clinical trials of other medications within the last 4 weeks\nWho are pregnant or lactating\nWho are considered not eligible by the investigator",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"30 Years",
          "MaximumAge":"80 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "CentralContactList":{
            "CentralContact":[
              {
                "CentralContactName":"Beom S Jeon, MD, PhD",
                "CentralContactRole":"Contact",
                "CentralContactPhone":"82-2-2072-2876",
                "CentralContactEMail":"brain@snu.ac.kr"
              },{
                "CentralContactName":"Ji Young Yun, MD",
                "CentralContactRole":"Contact",
                "CentralContactPhone":"82-2-2072-0359",
                "CentralContactEMail":"dream-yoon@hanmail.net"
              }
            ]
          },
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Beom S Jeon, MD, PhD",
                "OverallOfficialAffiliation":"Seoul National University Hospital",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Seoul National University Hospital",
                "LocationStatus":"Recruiting",
                "LocationCity":"Seoul",
                "LocationZip":"110-744",
                "LocationCountry":"Korea, Republic of",
                "LocationContactList":{
                  "LocationContact":[
                    {
                      "LocationContactName":"Beom S. Jeon, MD, PhD",
                      "LocationContactRole":"Contact",
                      "LocationContactPhone":"82-2-2072-2876",
                      "LocationContactEMail":"brain@snu.ac.kr"
                    },{
                      "LocationContactName":"Ji Y Yun, MD",
                      "LocationContactRole":"Contact",
                      "LocationContactPhone":"82-2-2072-0359",
                      "LocationContactEMail":"dream-yoon@hanmail.net"
                    },{
                      "LocationContactName":"Beom S. Jeon, MD, PhD",
                      "LocationContactRole":"Principal Investigator"
                    },{
                      "LocationContactName":"Han-Joon Kim, MD",
                      "LocationContactRole":"Sub-Investigator"
                    },{
                      "LocationContactName":"Ji Y Yun, MD",
                      "LocationContactRole":"Sub-Investigator"
                    },{
                      "LocationContactName":"Young Eun Kim, MD",
                      "LocationContactRole":"Sub-Investigator"
                    }
                  ]
                }
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"20110012",
                "ReferenceType":"background",
                "ReferenceCitation":"Jenner P, Könen-Bergmann M, Schepers C, Haertter S. Pharmacokinetics of a once-daily extended-release formulation of pramipexole in healthy male volunteers: three studies. Clin Ther. 2009 Nov;31(11):2698-711. doi: 10.1016/j.clinthera.2009.10.018."
              },{
                "ReferencePMID":"20669265",
                "ReferenceType":"background",
                "ReferenceCitation":"Rascol O, Barone P, Hauser RA, Mizuno Y, Poewe W, Schapira AH, Salin L, Sohr M, Debieuvre C; Pramipexole Switch Study Group. Efficacy, safety, and tolerability of overnight switching from immediate- to once daily extended-release pramipexole in early Parkinson's disease. Mov Disord. 2010 Oct 30;25(14):2326-32. doi: 10.1002/mds.23262."
              },{
                "ReferencePMID":"28265478",
                "ReferenceType":"derived",
                "ReferenceCitation":"Yun JY, Kim YE, Yang HJ, Kim HJ, Jeon B. Twice-Daily versus Once-Daily Pramipexole Extended Release Dosage Regimens in Parkinson's Disease. Parkinsons Dis. 2017;2017:8518929. doi: 10.1155/2017/8518929. Epub 2017 Feb 7."
              }
            ]
          }
        }
      },
      "AnnotationSection":{
        "AnnotationModule":{
          "UnpostedAnnotation":{
            "UnpostedResponsibleParty":"BS Jeon, Professor, Seoul National University Hospital",
            "UnpostedEventList":{
              "UnpostedEvent":[
                {
                  "UnpostedEventType":"Release",
                  "UnpostedEventDate":"June 13, 2017"
                },{
                  "UnpostedEventType":"Reset",
                  "UnpostedEventDate":"October 31, 2017"
                }
              ]
            }
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000077487",
                "InterventionMeshTerm":"Pramipexole"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000000975",
                "InterventionAncestorTerm":"Antioxidants"
              },{
                "InterventionAncestorId":"D000045504",
                "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action"
              },{
                "InterventionAncestorId":"D000020011",
                "InterventionAncestorTerm":"Protective Agents"
              },{
                "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"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M1813",
                "InterventionBrowseLeafName":"Pramipexole",
                "InterventionBrowseLeafAsFound":"Mirapex",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M2873",
                "InterventionBrowseLeafName":"Antioxidants",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M20453",
                "InterventionBrowseLeafName":"Protective Agents",
                "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"
              }
            ]
          }
        }
      }
    }
  }
}