Nctid:
NCT06236230
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"=>"C000071192", "term"=>"Entacapone"}], "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"=>"D000065098", "term"=>"Catechol O-Methyltransferase Inhibitors"}], "browseLeaves"=>[{"id"=>"M10982", "name"=>"Levodopa", "asFound"=>"2nd", "relevance"=>"HIGH"}, {"id"=>"M5489", "name"=>"Carbidopa", "asFound"=>"Direction", "relevance"=>"HIGH"}, {"id"=>"M252093", "name"=>"Entacapone", "asFound"=>"Fingertip", "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"=>"T373", "name"=>"Catechol", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Dyskinesia Agents", "abbrev"=>"AnDyAg"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Cardiotonic Agents", "abbrev"=>"CaAg"}, {"name"=>"Other Dietary Supplements", "abbrev"=>"Ot"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE4"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>60}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-11-15", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2023-12", "completionDateStruct"=>{"date"=>"2024-12-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-24", "studyFirstSubmitDate"=>"2024-01-24", "studyFirstSubmitQcDate"=>"2024-01-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-06-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) III Score", "timeFrame"=>"Baseline, Week 8", "description"=>"The UPDRS is a standardized assessment scale used to measure the patient's disease state. UPDRS Part III measures the motor function of the patient. A higher score indicates greater disability."}], "secondaryOutcomes"=>[{"measure"=>"Change From Baseline in UPDRS II Score", "timeFrame"=>"Baseline, Week 8", "description"=>"The UPDRS is a standardized assessment scale used to measure the patient's disease state. UPDRS Part II measures the patient's activities of daily living. A higher score indicates greater disability."}, {"measure"=>"Change From Baseline in Health-related Quality of Life Assessed Using the 39-item Parkinson's Disease Questionnaire (PDQ-39)", "timeFrame"=>"Baseline, Week 8", "description"=>"The PDQ-39 instrument is used to assess quality of life in individuals with PD. A lower score indicates better quality of life."}, {"measure"=>"Incidence of dyskinesia and wearing off", "timeFrame"=>"Baseline, Week 8", "description"=>"Dyskinesia and wearing off are common motor complications. A motor complications patient questionnaire will be record."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Parkinson Disease", "levodopa/carbidopa/entacapone"], "conditions"=>["Parkinson Disease"]}, "referencesModule"=>{"references"=>[{"pmid"=>"30178019", "type"=>"BACKGROUND", "citation"=>"Homayoun H. Parkinson Disease. Ann Intern Med. 2018 Sep 4;169(5):ITC33-ITC48. doi: 10.7326/AITC201809040."}, {"pmid"=>"11391738", "type"=>"BACKGROUND", "citation"=>"Ahlskog JE, Muenter MD. Frequency of levodopa-related dyskinesias and motor fluctuations as estimated from the cumulative literature. Mov Disord. 2001 May;16(3):448-58. doi: 10.1002/mds.1090."}, {"pmid"=>"28813703", "type"=>"BACKGROUND", "citation"=>"Li J, Lou Z, Liu X, Sun Y, Chen J. Efficacy and Safety of Adjuvant Treatment with Entacapone in Advanced Parkinson's Disease with Motor Fluctuation: A Systematic Meta-Analysis. Eur Neurol. 2017;78(3-4):143-153. doi: 10.1159/000479555. Epub 2017 Aug 16."}, {"pmid"=>"21437987", "type"=>"BACKGROUND", "citation"=>"Hauser RA, Auinger P; Parkinson Study Group. Determination of minimal clinically important change in early and advanced Parkinson's disease. Mov Disord. 2011 Apr;26(5):813-8. doi: 10.1002/mds.23638. Epub 2011 Mar 24."}, {"pmid"=>"24253234", "type"=>"BACKGROUND", "citation"=>"Tolosa E, Hernandez B, Linazasoro G, Lopez-Lozano JJ, Mir P, Marey J, Kulisevsky J. Efficacy of levodopa/carbidopa/entacapone versus levodopa/carbidopa in patients with early Parkinson's disease experiencing mild wearing-off: a randomised, double-blind trial. J Neural Transm (Vienna). 2014 Apr;121(4):357-66. doi: 10.1007/s00702-013-1114-x. Epub 2013 Nov 20."}, {"pmid"=>"19058133", "type"=>"BACKGROUND", "citation"=>"Hauser RA, Panisset M, Abbruzzese G, Mancione L, Dronamraju N, Kakarieka A; FIRST-STEP Study Group. Double-blind trial of levodopa/carbidopa/entacapone versus levodopa/carbidopa in early Parkinson's disease. Mov Disord. 2009 Mar 15;24(4):541-50. doi: 10.1002/mds.22343."}]}, "descriptionModule"=>{"briefSummary"=>"This is a, open-label, single-arm 8-week investigation of levodopa/carbidopa/entacapone in the treatment of early Parkinson's disease.", "detailedDescription"=>"This study will enroll subjects who have a diagnosis of PD with Hoehn-Yahr stage 1.5-3.0 and assess the impact of low dosage of levodopa/carbidopa/entacapone treatment on the motor function and quality of life among PD patients."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"80 years", "minimumAge"=>"30 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Male or female and greater from 30 to 80.\n* Diagnosis of idiopathic PD according to the MDS PD Diagnostic Criteria (2015).\n* Hoehn-Yahr stage of 1.5-3.0 (\"open\" stage).\n* Not on anti-PD medication or stable on anti-PD medication for at least 30 days.\n\nExclusion Criteria:\n\n* Diagnosis of atypical Parkinsonian syndrome, vascular Parkinsonism or drug-induced Parkinsonism.\n* History of surgery within 6 months.\n* Alcoholism, drug abuse, or severe cognitive impairment (including severe Alzheimer's disease)\n* Psychiatric illness, epilepsy, pregnancy and breastfeeding, and clinically significant concomitant illnesses\n* Participation in another clinical trial within 2 months.\n* With dyskinesia.\n* Any other condition that, in the opinion of the investigator, makes them ineligible for enrolment."}, "identificationModule"=>{"nctId"=>"NCT06236230", "briefTitle"=>"Basic and Clinical Studies of Levodopa/Carbidopa/Entacapone in the Treatment of Early Parkinson's Disease", "organization"=>{"class"=>"OTHER", "fullName"=>"Second Affiliated Hospital of Soochow University"}, "officialTitle"=>"Basic and Clinical Studies of Levodopa/Carbidopa/Entacapone in the Treatment of Early Parkinson's Disease", "orgStudyIdInfo"=>{"id"=>"JD-LK2023062-IR01"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"levodopa/carbidopa/entacapone", "description"=>"levodopa/carbidopa/entacapone is a combination drug consisting of levodopa, carbidopa, and entacapone. Each tablet contains a 1:4 ratio of carbidopa to levodopa and 200 mg of entacapone. The optimum daily dosage of levodopa/carbidopa/entacapone must be determined by careful titration in each patient.", "interventionNames"=>["Drug: levodopa/carbidopa/entacapone"]}], "interventions"=>[{"name"=>"levodopa/carbidopa/entacapone", "type"=>"DRUG", "otherNames"=>["Stalevo"], "description"=>"On Day 1, subjects will be treated with levodopa/carbidopa/entacapone. Based on previous regimen. The dosage of levodopa/carbidopa/entacapone will be equal to the previous total daily dose of LD, and the frequency of administration of levodopa/carbidopa/entacapone is three or four times a day.\n\nLevodopa/carbidopa/entacapone could be titrated in next 2 weeks according to the investigator's judgment, based on individual clinical response and tolerability.\n\nAfter 2-week titration, the dose of levodopa/carbidopa/entacapone will remain as constant as possible to the end of study.", "armGroupLabels"=>["levodopa/carbidopa/entacapone"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"2I5004", "city"=>"Shanghai", "state"=>"Shanghai", "status"=>"RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Chun-Feng Liu, MD,PhD", "role"=>"CONTACT", "email"=>"liuchunfeng@suda.edu.cn", "phone"=>"+8613606210609"}], "facility"=>"The Second Affiliated Hospital of Soochow University", "geoPoint"=>{"lat"=>31.22222, "lon"=>121.45806}}], "centralContacts"=>[{"name"=>"Chun-feng Liu, MD,PhD", "role"=>"CONTACT", "email"=>"liuchunfeng@suda.edu.cn", "phone"=>"+8613606210609"}], "overallOfficials"=>[{"name"=>"Chun-Feng Liu, MD,PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Second Affiliated Hospital of Soochow University"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Second Affiliated Hospital of Soochow University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
