{
  "FullStudy":{
    "Rank":217674,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01518309",
          "OrgStudyIdInfo":{
            "OrgStudyId":"ACP-103-010"
          },
          "Organization":{
            "OrgFullName":"ACADIA Pharmaceuticals Inc.",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"An Open-label Safety Study of Pimavanserin in Parkinson's Disease Patients"
        },
        "StatusModule":{
          "StatusVerifiedDate":"April 2017",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"November 2004"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"May 2013",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"May 2013",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"December 16, 2008",
          "StudyFirstSubmitQCDate":"January 25, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 26, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"April 18, 2017",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"April 19, 2017",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"ACADIA Pharmaceuticals Inc.",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{},
        "DescriptionModule":{
          "BriefSummary":"This is an open-label extension study to assess the long-term safety and tolerability of pimavanserin (ACP-103) in subjects with Parkinson's Disease Psychosis (PDP)."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Parkinson's Disease Psychosis"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 2"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"39",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"pimavanserin tartrate (ACP-103)",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Tablets taken once daily by mouth at 20, 40, or 60 mg doses",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: pimavanserin tartrate (ACP-103)"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"pimavanserin tartrate (ACP-103)",
                "InterventionDescription":"Tablets taken once daily by mouth at 20, 40, or 60 mg doses",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "pimavanserin tartrate (ACP-103)"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Safety",
                "PrimaryOutcomeTimeFrame":"For as long as pimavanserin is considered to be tolerated and beneficial to enrolled patients (up to 8 years)"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria-\n\nPatients of any age, male or female with a clinical diagnosis of idiopathic Parkinson's disease, who participated in a previous (Phase II) clinical trial that evaluated pimavanserin\nPatients who may, in the opinion of the treating physician, benefit from continued therapy with pimavanserin\nPatient is willing and able to provide consent\n\nExclusion Criteria-\n\nFemale patient of childbearing potential\nPatient has a clinically significant concurrent medical illness\nPatient is judged by the treating physician to be inappropriate for the study.",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "StdAgeList":{
            "StdAge":[
              "Child",
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationCity":"Danbury",
                "LocationState":"Connecticut",
                "LocationZip":"06810",
                "LocationCountry":"United States"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"C000510793",
                "InterventionMeshTerm":"Pimavanserin"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000000978",
                "InterventionAncestorTerm":"Antiparkinson Agents"
              },{
                "InterventionAncestorId":"D000018726",
                "InterventionAncestorTerm":"Anti-Dyskinesia Agents"
              },{
                "InterventionAncestorId":"D000014150",
                "InterventionAncestorTerm":"Antipsychotic Agents"
              },{
                "InterventionAncestorId":"D000014149",
                "InterventionAncestorTerm":"Tranquilizing Agents"
              },{
                "InterventionAncestorId":"D000002492",
                "InterventionAncestorTerm":"Central Nervous System Depressants"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              },{
                "InterventionAncestorId":"D000011619",
                "InterventionAncestorTerm":"Psychotropic Drugs"
              },{
                "InterventionAncestorId":"D000058830",
                "InterventionAncestorTerm":"Serotonin 5-HT2 Receptor Antagonists"
              },{
                "InterventionAncestorId":"D000012702",
                "InterventionAncestorTerm":"Serotonin Antagonists"
              },{
                "InterventionAncestorId":"D000018490",
                "InterventionAncestorTerm":"Serotonin Agents"
              },{
                "InterventionAncestorId":"D000018377",
                "InterventionAncestorTerm":"Neurotransmitter Agents"
              },{
                "InterventionAncestorId":"D000045504",
                "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M272225",
                "InterventionBrowseLeafName":"Pimavanserin",
                "InterventionBrowseLeafAsFound":"Pimavanserin",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M2876",
                "InterventionBrowseLeafName":"Antiparkinson Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M15487",
                "InterventionBrowseLeafName":"Antipsychotic Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M13057",
                "InterventionBrowseLeafName":"Psychotropic Drugs",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M14095",
                "InterventionBrowseLeafName":"Serotonin",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M19088",
                "InterventionBrowseLeafName":"Neurotransmitter Agents",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"AnDyAg",
                "InterventionBrowseBranchName":"Anti-Dyskinesia Agents"
              },{
                "InterventionBrowseBranchAbbrev":"CNSDep",
                "InterventionBrowseBranchName":"Central Nervous System Depressants"
              },{
                "InterventionBrowseBranchAbbrev":"PsychDr",
                "InterventionBrowseBranchName":"Psychotropic Drugs"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        },
        "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":"M3396",
                "ConditionBrowseLeafName":"Mental Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M11796",
                "ConditionBrowseLeafName":"Parkinson Disease",
                "ConditionBrowseLeafAsFound":"Parkinson's Disease",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M13056",
                "ConditionBrowseLeafName":"Psychotic Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "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":"BXM",
                "ConditionBrowseBranchName":"Behaviors and Mental Disorders"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC10",
                "ConditionBrowseBranchName":"Nervous System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC04",
                "ConditionBrowseBranchName":"Cancers and Other Neoplasms"
              },{
                "ConditionBrowseBranchAbbrev":"BC17",
                "ConditionBrowseBranchName":"Skin and Connective Tissue Diseases"
              }
            ]
          }
        }
      }
    }
  }
}