Nctid:
NCT06614153
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000010300", "term"=>"Parkinson Disease"}], "ancestors"=>[{"id"=>"D000020734", "term"=>"Parkinsonian Disorders"}, {"id"=>"D000001480", "term"=>"Basal Ganglia Diseases"}, {"id"=>"D000001927", "term"=>"Brain Diseases"}, {"id"=>"D000002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000009069", "term"=>"Movement Disorders"}, {"id"=>"D000080874", "term"=>"Synucleinopathies"}, {"id"=>"D000019636", "term"=>"Neurodegenerative Diseases"}], "browseLeaves"=>[{"id"=>"M13213", "name"=>"Parkinson Disease", "asFound"=>"Parkinson's Disease", "relevance"=>"HIGH"}, {"id"=>"M22494", "name"=>"Parkinsonian Disorders", "relevance"=>"LOW"}, {"id"=>"M25603", "name"=>"Ganglion Cysts", "relevance"=>"LOW"}, {"id"=>"M16358", "name"=>"Synovial Cyst", "relevance"=>"LOW"}, {"id"=>"M4774", "name"=>"Basal Ganglia Diseases", "relevance"=>"LOW"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M12029", "name"=>"Movement Disorders", "relevance"=>"LOW"}, {"id"=>"M2217", "name"=>"Synucleinopathies", "relevance"=>"LOW"}, {"id"=>"M21558", "name"=>"Neurodegenerative Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000007980", "term"=>"Levodopa"}, {"id"=>"D000002230", "term"=>"Carbidopa"}, {"id"=>"C000009265", "term"=>"Carbidopa, levodopa drug combination"}], "ancestors"=>[{"id"=>"D000000978", "term"=>"Antiparkinson Agents"}, {"id"=>"D000018726", "term"=>"Anti-Dyskinesia Agents"}, {"id"=>"D000015259", "term"=>"Dopamine Agents"}, {"id"=>"D000018377", "term"=>"Neurotransmitter Agents"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000065105", "term"=>"Aromatic Amino Acid Decarboxylase Inhibitors"}, {"id"=>"D000004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000000276", "term"=>"Adjuvants, Immunologic"}, {"id"=>"D000007155", "term"=>"Immunologic Factors"}, {"id"=>"D000018491", "term"=>"Dopamine Agonists"}], "browseLeaves"=>[{"id"=>"M10982", "name"=>"Levodopa", "asFound"=>"2nd", "relevance"=>"HIGH"}, {"id"=>"M5489", "name"=>"Carbidopa", "asFound"=>"Direction", "relevance"=>"HIGH"}, {"id"=>"M250674", "name"=>"Carbidopa, levodopa drug combination", "asFound"=>"HIV Seronegativity", "relevance"=>"HIGH"}, {"id"=>"M4295", "name"=>"Antiparkinson Agents", "relevance"=>"LOW"}, {"id"=>"M7473", "name"=>"Dopamine", "relevance"=>"LOW"}, {"id"=>"M17962", "name"=>"Dopamine Agents", "relevance"=>"LOW"}, {"id"=>"M20504", "name"=>"Neurotransmitter Agents", "relevance"=>"LOW"}, {"id"=>"M30461", "name"=>"Aromatic Amino Acid Decarboxylase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M3628", "name"=>"Adjuvants, Immunologic", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}, {"id"=>"M20595", "name"=>"Dopamine Agonists", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Dyskinesia Agents", "abbrev"=>"AnDyAg"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Cardiotonic Agents", "abbrev"=>"CaAg"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"CROSSOVER"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>61}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2023-05-16", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2024-03-04", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-09-23", "studyFirstSubmitDate"=>"2024-09-23", "studyFirstSubmitQcDate"=>"2024-09-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Change from baseline in average percent \"Off\" time during waking hours at Day 33", "timeFrame"=>"Last three days collected at the end of treatment period"}], "secondaryOutcomes"=>[{"measure"=>"\"Off\" and\"On\" time hours during in clinic observation", "timeFrame"=>"Days 1 and 13"}, {"measure"=>"MDS-UPDRS Part III", "timeFrame"=>"Days 1 and 33"}, {"measure"=>"Change from baseline in \"Off\" time at Day 33", "timeFrame"=>"Last three days collected at the end of treatment period"}, {"measure"=>"Change from baseline in the Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at Day 33", "timeFrame"=>"Day 33"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Parkinson's Disease"]}, "descriptionModule"=>{"briefSummary"=>"The study is a multicenter, randomized, open-label, active-controlled, Phase II clinical study. The aim of this trial is to evaluated the pharmacokinetics, pharmacodynamics,efficacy and assessed the safety of HRG2010 compared with a sustained-release cabridopa-levodopa formulation in Parkinson's Disease Patients With Motor Fluctuations."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"75 years", "minimumAge"=>"40 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Male or female participants diagnosed at age ≥ 40 years with PD, consistent with the International Parkinson and Movement Disorder Society Clinical Diagnostic Criteria and who are being treated with stable regimens of DDCI+LD but experiencing motor fluctuations.\n2. Mini Mental State Examination (MMSE) ≥ 25 at Screening Visit.\n3. Hoehn and Yahr Stage II-IV when \"on\" at Screening Visit.\n4. At Screening, the participant has predictable \"Off\" periods.\n5. Able and willing to provide a written informed consent.\n\nExclusion Criteria:\n\n1. Diagnosed with atypical or secondary parkinsonism.\n2. History of narrow angle glaucoma、peptic ulcer disease or upper gastrointestinal hemorrhage.\n3. Had prior functional neurosurgical treatment for PD or if such procedure(s) are planned or anticipated during the study period.\n4. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method.\n5. In the opinion of the clinical investigator, Subjects who should not participate in the study."}, "identificationModule"=>{"nctId"=>"NCT06614153", "briefTitle"=>"Pharmacokinetics,Pharmacodynamics,Efficacy and Safety of HRG2010 in Parkinson's Disease Patients With Motor Fluctuations", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Jiangsu HengRui Medicine Co., Ltd."}, "officialTitle"=>"A Randomized, Open-label, Controlled, Single-dose, Multiple-dose Phase II Study to Evaluate the Pharmacokinetics,Pharmacodynamics,Efficacy and Safety of HRG2010 in Parkinson's Disease Patients With Motor Fluctuations", "orgStudyIdInfo"=>{"id"=>"HRG2010-201"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Group A，Subjects will receive HRG2010(I)", "description"=>"administered orally", "interventionNames"=>["Drug: HRG2010(I)"]}, {"type"=>"EXPERIMENTAL", "label"=>"Group B，Subjects will receive HRG2010(II)", "description"=>"administered orally", "interventionNames"=>["Drug: HRG2010(II)"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Group C，Subjects will receive Sustained-release", "description"=>"Carbidopa/Levodopa administered orally", "interventionNames"=>["Drug: Sustained-release Carbidopa/Levodopa"]}], "interventions"=>[{"name"=>"HRG2010(I)", "type"=>"DRUG", "description"=>"HRG2010(I)", "armGroupLabels"=>["Group A，Subjects will receive HRG2010(I)"]}, {"name"=>"HRG2010(II)", "type"=>"DRUG", "description"=>"HRG2010(II)", "armGroupLabels"=>["Group B，Subjects will receive HRG2010(II)"]}, {"name"=>"Sustained-release Carbidopa/Levodopa", "type"=>"DRUG", "description"=>"Sustained-release Carbidopa/Levodopa", "armGroupLabels"=>["Group C，Subjects will receive Sustained-release"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"100730", "city"=>"Beijing", "state"=>"Beijing", "country"=>"China", "facility"=>"Beijing Hospital", "geoPoint"=>{"lat"=>39.9075, "lon"=>116.39723}}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Jiangsu HengRui Medicine Co., Ltd.", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
