Nctid:
NCT00001489
Payload:
{"FullStudy"=>{"Rank"=>497903, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"June 24, 2024"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000004827", "ConditionMeshTerm"=>"Epilepsy"}, {"ConditionMeshId"=>"D000017029", "ConditionMeshTerm"=>"Epilepsy, Complex Partial"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000001927", "ConditionAncestorTerm"=>"Brain Diseases"}, {"ConditionAncestorId"=>"D000002493", "ConditionAncestorTerm"=>"Central Nervous System Diseases"}, {"ConditionAncestorId"=>"D000009422", "ConditionAncestorTerm"=>"Nervous System Diseases"}, {"ConditionAncestorId"=>"D000004828", "ConditionAncestorTerm"=>"Epilepsies, Partial"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M7983", "ConditionBrowseLeafName"=>"Epilepsy", "ConditionBrowseLeafAsFound"=>"Epilepsy", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M15452", "ConditionBrowseLeafName"=>"Seizures", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M19365", "ConditionBrowseLeafName"=>"Epilepsy, Complex Partial", "ConditionBrowseLeafAsFound"=>"Epilepsy, Complex Partial", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M5204", "ConditionBrowseLeafName"=>"Brain Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M5742", "ConditionBrowseLeafName"=>"Central Nervous System Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M7984", "ConditionBrowseLeafName"=>"Epilepsies, Partial", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Nervous System Diseases", "ConditionBrowseBranchAbbrev"=>"BC10"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}]}}, "InterventionBrowseModule"=>{"InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M22627", "InterventionBrowseLeafName"=>"Vigabatrin", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Anticonvulsants", "InterventionBrowseBranchAbbrev"=>"AntiConv"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"StudyType"=>"Observational", "EnrollmentInfo"=>{"EnrollmentCount"=>"20"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"October 1994"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"August 1999", "CompletionDateStruct"=>{"CompletionDate"=>"August 2000"}, "LastUpdateSubmitDate"=>"March 3, 2008", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"December 9, 2002", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"March 4, 2008", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"December 10, 2002", "StudyFirstPostDateType"=>"Estimate"}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Cerebral Metabolism", "Complex Partial Seizures", "Epilepsy"]}, "ConditionList"=>{"Condition"=>["Epilepsy", "Epilepsy, Complex Partial"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"2474312", "ReferenceType"=>"background", "ReferenceCitation"=>"Ben-Menachem E, Persson LI, Schechter PJ, Haegele KD, Huebert N, Hardenberg J, Dahlgren L, Mumford JP. The effect of different vigabatrin treatment regimens on CSF biochemistry and seizure control in epileptic patients. Br J Clin Pharmacol. 1989;27 Suppl 1(Suppl 1):79S-85S. doi: 10.1111/j.1365-2125.1989.tb03466.x."}, {"ReferencePMID"=>"3808298", "ReferenceType"=>"background", "ReferenceCitation"=>"Browne TR, Mattson RH, Penry JK, Smith DB, Treiman DM, Wilder BJ, Ben-Menachem E, Napoliello MJ, Sherry KM, Szabo GK. Vigabatrin for refractory complex partial seizures: multicenter single-blind study with long-term follow-up. Neurology. 1987 Feb;37(2):184-9. doi: 10.1212/wnl.37.2.184."}]}}, "DescriptionModule"=>{"BriefSummary"=>"This study is designed to test the effects of vigabatrin (gamma-vinyl-GABA) an experimental drug used for the treatment of epilepsy. The study will use positron emission tomography (PET scan) to detect areas of the brain receiving increased blood flow and using increased amounts of glucose. Increases in blood flow and glucose use are good indicators of brain activity.\n\nResearchers are interested in determining the effects of Vigabatrin on brain blood flow and glucose use.", "DetailedDescription"=>"This double-blind placebo-controlled parallel design protocol will investigate the effects of gamma-vinyl-GABA (vigabatrin--GVG) an experimental antiepileptic drug, on cerebral glucose metabolism (LCMRglc), blood flow (CBF), and seizure frequency, in patients with uncontrolled complex partial (CPS) and secondary generalized seizures (GTCS). Positron Emission Tomography (PET) will be used to measure CBF and LCMRglc."}, "EligibilityModule"=>{"Gender"=>"All", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Localization-related epilepsy.\n\nUncontrolled seizures.\n\nAbility to tolerate tegretol monotherapy.\n\nNo systemic illness requiring drug therapy.\n\nNo illness that might be made worse by vigabatrin."}, "IdentificationModule"=>{"NCTId"=>"NCT00001489", "BriefTitle"=>"Effect of Vigabatrin on Brain Blood Flow and Glucose Metabolism", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"The Effect of Vigabatrin on Cerebral Blood Flow and Glucose Metabolism", "OrgStudyIdInfo"=>{"OrgStudyId"=>"950008"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"95-N-0008"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20892", "LocationCity"=>"Bethesda", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"National Institute of Neurological Disorders and Stroke (NINDS)"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Neurological Disorders and Stroke (NINDS)", "LeadSponsorClass"=>"NIH"}}}}}}
