{ "FullStudy":{ "Rank":217556, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01519856", "OrgStudyIdInfo":{ "OrgStudyId":"PIR-008/K" }, "Organization":{ "OrgFullName":"Desitin Arzneimittel GmbH", "OrgClass":"INDUSTRY" }, "BriefTitle":"PIRLONG-PD Safety and Efficacy of Piribedil in Parkinson's Disease During Long Term Therapy", "OfficialTitle":"Efficacy and Safety of Long-term Therapy With Piribedil (CLARIUM) in Patients With M. Parkinson Under Consideration of Quality of Life Parameters and Cognitive Function", "Acronym":"PIR-008/K" }, "StatusModule":{ "StatusVerifiedDate":"July 2015", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"June 2009" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"December 2014", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"February 2015", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"March 12, 2010", "StudyFirstSubmitQCDate":"January 26, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 27, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 28, 2016", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 29, 2016", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Desitin Arzneimittel GmbH", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"Non-Ergot Dopamine agonists are meanwhile the drugs of first-choice in the treatment of Parkinson's disease. The receptor profile of the non-ergot dopamine-agonist piribedil is unique. In addition to agonistic effects on dopaminergic D2- and D3-receptors piribedil has adrenergic alpha-2A- and alpha-2C-receptors antagonisic properties. There is evidence from the literature that the antagonistic properties of piribedil are correlated with an improvement of cognitive function and vigilance parameters in parkinson's disease. The aim of the present non-interventional study is to investigate the safety and efficacy of piribedil during long-term therapy of patients with M. Parkinson under consideration of cognitive functions and quality of life." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Parkinson's Disease" ] }, "KeywordList":{ "Keyword":[ "open", "non-intervention", "observational" ] } }, "DesignModule":{ "StudyType":"Observational", "DesignInfo":{ "DesignTimePerspectiveList":{ "DesignTimePerspective":[ "Prospective" ] } }, "EnrollmentInfo":{ "EnrollmentCount":"908", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"tablet", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: piribedil (Clarium)" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"piribedil (Clarium)", "InterventionDescription":"oral tablets, 50 mg", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "tablet" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Adverse event profile during long term therapy with piribedil in patients with Parkinson's disease", "PrimaryOutcomeTimeFrame":"4 years" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Influence on quality of life", "SecondaryOutcomeTimeFrame":"4 years" },{ "SecondaryOutcomeMeasure":"Quality of life parameters", "SecondaryOutcomeTimeFrame":"4 years" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nnewly diagnosed or advanced idiopathic Parkinson's disease\nmale and female patients over 18 years of age\nindication for treatment with piribedil according to Summary of Product Characteristics (SmPC)\n\nExclusion Criteria:\n\nin line with piribedil SmPC\nin particular hypersensitivity to piribedil or to any of the excipients and pregnancy and lactation as stated in the SmPC", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] }, "StudyPopulation":"male and female patients with Morbus Parkinson", "SamplingMethod":"Non-Probability Sample" }, "ContactsLocationsModule":{ "LocationList":{ "Location":[ { "LocationFacility":"Dr. Erich Scholz", "LocationCity":"Boeblingen", "LocationState":"Baden-Wuertemberg", "LocationZip":"71034", "LocationCountry":"Germany" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"16267842", "ReferenceType":"background", "ReferenceCitation":"Castro-Caldas A, Delwaide P, Jost W, Merello M, Williams A, Lamberti P, Aguilar M, Del Signore S, Cesaro P; Parkinson-Control Study Group. The Parkinson-Control study: a 1-year randomized, double-blind trial comparing piribedil (150 mg/day) with bromocriptine (25 mg/day) in early combination with levodopa in Parkinson's disease. Mov Disord. 2006 Apr;21(4):500-9." },{ "ReferencePMID":"17013922", "ReferenceType":"background", "ReferenceCitation":"Rascol O, Dubois B, Caldas AC, Senn S, Del Signore S, Lees A; Parkinson REGAIN Study Group. Early piribedil monotherapy of Parkinson's disease: A planned seven-month report of the REGAIN study. Mov Disord. 2006 Dec;21(12):2110-5." },{ "ReferencePMID":"15138753", "ReferenceType":"background", "ReferenceCitation":"Peretti CS, Gierski F, Harrois S. Cognitive skill learning in healthy older adults after 2 months of double-blind treatment with piribedil. Psychopharmacology (Berl). 2004 Nov;176(2):175-81. Epub 2004 May 12." },{ "ReferencePMID":"11903513", "ReferenceType":"background", "ReferenceCitation":"Schück S, Bentué-Ferrer D, Kleinermans D, Reymann JM, Polard E, Gandon JM, Allain H. Psychomotor and cognitive effects of piribedil, a dopamine agonist, in young healthy volunteers. Fundam Clin Pharmacol. 2002 Feb;16(1):57-65." } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000010891", "InterventionMeshTerm":"Piribedil" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "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" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M18206", "InterventionBrowseLeafName":"Loratadine", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M12365", "InterventionBrowseLeafName":"Piribedil", "InterventionBrowseLeafAsFound":"Piribedil", "InterventionBrowseLeafRelevance":"high" },{ "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":"AAll", "InterventionBrowseBranchName":"Anti-Allergic Agents" },{ "InterventionBrowseBranchAbbrev":"Derm", "InterventionBrowseBranchName":"Dermatologic Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"AnDyAg", "InterventionBrowseBranchName":"Anti-Dyskinesia Agents" },{ "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" },{ "ConditionBrowseLeafId":"T6054", "ConditionBrowseLeafName":"Quality of Life", "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" },{ "ConditionBrowseBranchAbbrev":"BXM", "ConditionBrowseBranchName":"Behaviors and Mental Disorders" } ] } } } } } }