[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100471422":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":30,"locations":35,"responsibleParty":301,"collaborators":303,"id":306,"slug":307,"hasResults":308,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":314,"sex":315,"minAge":316,"maxAge":317,"enrollmentInfo":318,"targetDuration":30,"studyType":321,"phases":322,"briefSummary":324,"conditions":325,"keywords":30,"overallStatus":327,"whyStopped":328,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":337},{"fullName":5,"class":6},"Biogen","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BIIB122 225 mg","EXPERIMENTAL","Participants will receive 225 mg of BIIB122 tablets, orally, once daily (QD) for up to 180 weeks.",[13],"Drug: BIIB122",{"label":15,"type":16,"description":17,"interventionNames":18},"BIIB122-Matching Placebo","PLACEBO_COMPARATOR","Participants will receive BIIB122-matching placebo tablets, orally, QD for up to 180 weeks.",[19],"Drug: BIIB122-Matching Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","BIIB122","Administered as specified in the treatment arm.",[9],[27],"DNL151",{"type":22,"name":15,"description":24,"armGroupLabels":29,"otherNames":30},[15],null,[32],{"name":33,"affiliation":5,"role":34},"Medical Director","STUDY_DIRECTOR",[36,49,59,68,78,87,97,107,116,122,132,142,151,163,173,183,193,202,214,223,234,246,256,266,274,280,289],{"facility":37,"status":30,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":30},"University of California San Francisco (UCSF)","San Francisco","California","94143","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-122.41942,37.77493,{"lat":47,"lon":46},{"facility":50,"status":30,"city":51,"state":52,"zip":53,"country":41,"countryCode":42,"cosmosGeoPoint":54,"geoPoint":58,"contacts":30},"University of Colorado","Aurora","Colorado","80045",{"type":44,"coordinates":55},[56,57],-104.83192,39.72943,{"lat":57,"lon":56},{"facility":60,"status":30,"city":61,"state":52,"zip":62,"country":41,"countryCode":42,"cosmosGeoPoint":63,"geoPoint":67,"contacts":30},"Rocky Mountain Movement Disorders Center, PC","Englewood","80113",{"type":44,"coordinates":64},[65,66],-104.98776,39.64777,{"lat":66,"lon":65},{"facility":69,"status":30,"city":70,"state":71,"zip":72,"country":41,"countryCode":42,"cosmosGeoPoint":73,"geoPoint":77,"contacts":30},"Parkinson's Disease and Movement Disorders Center","Boca Raton","Florida","33486",{"type":44,"coordinates":74},[75,76],-80.0831,26.35869,{"lat":76,"lon":75},{"facility":79,"status":30,"city":80,"state":71,"zip":81,"country":41,"countryCode":42,"cosmosGeoPoint":82,"geoPoint":86,"contacts":30},"USF Health Byrd Institute","Tampa","33613",{"type":44,"coordinates":83},[84,85],-82.45843,27.94752,{"lat":85,"lon":84},{"facility":88,"status":30,"city":89,"state":90,"zip":91,"country":41,"countryCode":42,"cosmosGeoPoint":92,"geoPoint":96,"contacts":30},"University of Kansas Medical Center Research Institute, Inc.","Kansas City","Kansas","66160",{"type":44,"coordinates":93},[94,95],-94.62746,39.11417,{"lat":95,"lon":94},{"facility":98,"status":30,"city":99,"state":100,"zip":101,"country":41,"countryCode":42,"cosmosGeoPoint":102,"geoPoint":106,"contacts":30},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":44,"coordinates":103},[104,105],-71.05977,42.35843,{"lat":105,"lon":104},{"facility":108,"status":30,"city":109,"state":109,"zip":110,"country":41,"countryCode":42,"cosmosGeoPoint":111,"geoPoint":115,"contacts":30},"Mount Sinai Beth Israel","New York","10003",{"type":44,"coordinates":112},[113,114],-74.00597,40.71427,{"lat":114,"lon":113},{"facility":117,"status":30,"city":109,"state":109,"zip":118,"country":41,"countryCode":42,"cosmosGeoPoint":119,"geoPoint":121,"contacts":30},"Weill Medical College of Cornell University","10021",{"type":44,"coordinates":120},[113,114],{"lat":114,"lon":113},{"facility":123,"status":30,"city":124,"state":125,"zip":126,"country":41,"countryCode":42,"cosmosGeoPoint":127,"geoPoint":131,"contacts":30},"Pennsylvania Hospital","Philadelphia","Pennsylvania","19107",{"type":44,"coordinates":128},[129,130],-75.16362,39.95238,{"lat":130,"lon":129},{"facility":133,"status":30,"city":134,"state":135,"zip":136,"country":41,"countryCode":42,"cosmosGeoPoint":137,"geoPoint":141,"contacts":30},"Evergreen Hospital Medical Center","Kirkland","Washington","98034",{"type":44,"coordinates":138},[139,140],-122.20874,47.68149,{"lat":140,"lon":139},{"facility":143,"status":30,"city":144,"state":135,"zip":145,"country":41,"countryCode":42,"cosmosGeoPoint":146,"geoPoint":150,"contacts":30},"Inland Northwest Research","Spokane","99202",{"type":44,"coordinates":147},[148,149],-117.42908,47.65966,{"lat":149,"lon":148},{"facility":152,"status":30,"city":153,"state":154,"zip":155,"country":156,"countryCode":157,"cosmosGeoPoint":158,"geoPoint":162,"contacts":30},"Hôpital de la Timone","Marseille","Bouches-du-Rhône","13385","France","FR",{"type":44,"coordinates":159},[160,161],5.38107,43.29695,{"lat":161,"lon":160},{"facility":164,"status":30,"city":165,"state":166,"zip":167,"country":156,"countryCode":157,"cosmosGeoPoint":168,"geoPoint":172,"contacts":30},"Hopital Purpan","Toulouse","Haute Garonne","31059",{"type":44,"coordinates":169},[170,171],1.44367,43.60426,{"lat":171,"lon":170},{"facility":174,"status":30,"city":175,"state":176,"zip":177,"country":156,"countryCode":157,"cosmosGeoPoint":178,"geoPoint":182,"contacts":30},"CHU Rennes - Hopital Pontchaillou","Rennes","Ille Et Vilaine","35033",{"type":44,"coordinates":179},[180,181],-1.67431,48.11109,{"lat":181,"lon":180},{"facility":184,"status":30,"city":185,"state":186,"zip":187,"country":156,"countryCode":157,"cosmosGeoPoint":188,"geoPoint":192,"contacts":30},"Centre Hospitalier Universitaire de Lyon-Hospices Civils de Lyon-Hopital Pierre Wertheimer","Bron","Rhone","69500",{"type":44,"coordinates":189},[190,191],4.91303,45.73865,{"lat":191,"lon":190},{"facility":194,"status":30,"city":195,"state":30,"zip":196,"country":156,"countryCode":157,"cosmosGeoPoint":197,"geoPoint":201,"contacts":30},"Groupe Hospitalier Pitie-Salpetriere","Paris","75013",{"type":44,"coordinates":198},[199,200],2.3488,48.85341,{"lat":200,"lon":199},{"facility":203,"status":30,"city":204,"state":205,"zip":206,"country":207,"countryCode":208,"cosmosGeoPoint":209,"geoPoint":213,"contacts":30},"Universitaetsklinikum Tuebingen","Tübingen","Baden-Wurttemberg","72076","Germany","DE",{"type":44,"coordinates":210},[211,212],9.05222,48.52266,{"lat":212,"lon":211},{"facility":215,"status":30,"city":216,"state":30,"zip":217,"country":207,"countryCode":208,"cosmosGeoPoint":218,"geoPoint":222,"contacts":30},"Universitaetsklinikum Carl Gustav Carus TU Dresden","Dresden","1307",{"type":44,"coordinates":219},[220,221],13.73832,51.05089,{"lat":221,"lon":220},{"facility":224,"status":30,"city":225,"state":30,"zip":226,"country":227,"countryCode":228,"cosmosGeoPoint":229,"geoPoint":233,"contacts":30},"Fondazione IRCCS Istituto Neurologico Carlo Besta","Milan","20133","Italy","IT",{"type":44,"coordinates":230},[231,232],12.59836,42.78235,{"lat":232,"lon":231},{"facility":235,"status":30,"city":236,"state":237,"zip":238,"country":239,"countryCode":240,"cosmosGeoPoint":241,"geoPoint":245,"contacts":30},"Hospital General de Catalunya","Sant Cugat del Vallès","Barcelona","8190","Spain","ES",{"type":44,"coordinates":242},[243,244],2.08611,41.47063,{"lat":244,"lon":243},{"facility":247,"status":30,"city":248,"state":249,"zip":250,"country":239,"countryCode":240,"cosmosGeoPoint":251,"geoPoint":255,"contacts":30},"Hospital Universitario Marques de Valdecilla","Santander","Cantabria","38003",{"type":44,"coordinates":252},[253,254],-3.80493,43.46589,{"lat":254,"lon":253},{"facility":257,"status":30,"city":258,"state":259,"zip":260,"country":239,"countryCode":240,"cosmosGeoPoint":261,"geoPoint":265,"contacts":30},"Hospital Universitario Donostia","Donostia \u002F San Sebastian","Guipuzcoa","20014",{"type":44,"coordinates":262},[263,264],-1.97499,43.31283,{"lat":264,"lon":263},{"facility":267,"status":30,"city":237,"state":30,"zip":268,"country":239,"countryCode":240,"cosmosGeoPoint":269,"geoPoint":273,"contacts":30},"Hospital Universitari Vall d'Hebron","8035",{"type":44,"coordinates":270},[271,272],2.15899,41.38879,{"lat":272,"lon":271},{"facility":275,"status":30,"city":237,"state":30,"zip":276,"country":239,"countryCode":240,"cosmosGeoPoint":277,"geoPoint":279,"contacts":30},"Hospital Clinic de Barcelona","8036",{"type":44,"coordinates":278},[271,272],{"lat":272,"lon":271},{"facility":281,"status":30,"city":282,"state":30,"zip":283,"country":239,"countryCode":240,"cosmosGeoPoint":284,"geoPoint":288,"contacts":30},"Hospital Universitario Virgen del Rocio","Seville","41013",{"type":44,"coordinates":285},[286,287],-5.97317,37.38283,{"lat":287,"lon":286},{"facility":290,"status":30,"city":291,"state":292,"zip":293,"country":294,"countryCode":295,"cosmosGeoPoint":296,"geoPoint":300,"contacts":30},"Ninewells Hospital","Dundee","Tayside Region","DD1 9SY","United Kingdom","UK",{"type":44,"coordinates":297},[298,299],-2.97489,56.46913,{"lat":299,"lon":298},{"type":302,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[304],{"name":305,"class":6},"Denali Therapeutics Inc.","100471422","phase-3-a-study-to-assess-if-biib122-tablets-are-safe-and-can-slow-worsening-of-early-stage-parkinsons-disease-in-participants-with-specific-lrrk2-genetic-variants-between-the-ages-of-30-and-80-using-the-movement-disorder-society-unified-parkinsons-disease-rating-scale-100471422",true,"NCT05418673","A Study to Assess if BIIB122 Tablets Are Safe and Can Slow Worsening of Early-Stage Parkinson's Disease in Participants With Specific LRRK2 Genetic Variants Between the Ages of 30 and 80 Using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale","A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of BIIB122\u002FDNL151 in Participants With Parkinson's Disease and Pathogenic LRRK2 Variants","LIGHTHOUSE","Key Inclusion Criteria:\n\n* Clinical diagnosis of PD meeting the Movement Disorder Society Clinical Diagnostic Criteria within 5 years of the Screening Visit, inclusive, and at least 30 years of age at the time of diagnosis\n* Modified Hoehn and Yahr scale (mHY), Stages 1 to 2.5 (in OFF state), inclusive, at Screening\n* MDS-UPDRS Parts II and III (in OFF state) combined score ≤40 at Screening\n* Screening genetic test results verifying the presence of a pathogenic leucine-rich repeat kinase 2 (LRRK2) variant\n\nKey Exclusion Criteria:\n\n* Clinically significant neurologic disorder other than PD, including, but not limited to, stroke, dementia, or seizure within 5 years of Screening Visit, in the opinion of the Investigator\n* Clinical evidence of atypical parkinsonism (e.g., multiple-system atrophy or progressive supranuclear palsy) or evidence of drug-induced parkinsonism\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",false,"ALL","30 Years","80 Years",{"count":319,"type":320},7,"ACTUAL","INTERVENTIONAL",[323],"PHASE3","In this study, researchers will learn more about a study drug called BIIB122 in participants with early-stage Parkinson's disease (PD). The study will focus on participants with a specific genetic variant in their LRRK2 gene.\n\nThe main question researchers are trying to answer is if taking BIIB122 slows the worsening of PD more than placebo in the early stages of PD.\n\nTo help answer this question, researchers will use a questionnaire called the Movement Disorder Society-Unified Parkinson's Disease Rating Scale, also known as the MDS-UPDRS.\n\n* The MDS-UPDRS measures impairment and disability in people living with PD. It was created in the 1980s and is one of the most used rating scales for PD symptoms.\n* The MDS-UPDRS has 4 parts, and a higher score means more severe PD symptoms.\n* Part I assesses non-motor experiences of daily living, including but not limited to memory loss, problems sleeping, pain, depression, and anxiety.\n* Part II measures motor experiences of daily living.\n* Part III is the results of a motor symptoms exam by a medical professional.\n* Part IV records PD complications caused by motor symptoms.\n\nResearchers will also learn more about the safety of BIIB122.\n\nA description of how the study will be done is given below.\n\n* Participants will take BIIB122 or a placebo as tablets by mouth. A placebo looks like the study drug but contains no real medicine.\n* Participants will be in the study for 103 weeks to 187 weeks. This includes the screening and follow-up periods.\n* Participants will take BIIB122 or placebo 1 time a day for 96 to 180 weeks.\n* Participants can continue to take certain medications for PD. Participants must be on the same dose of medication for at least 90 days before the study begins.\n* Participants will visit the clinic less often as the study continues, ranging every 4 weeks to every 24 weeks.",[326],"Parkinson Disease","TERMINATED","Sponsor Decision","2024-05-31",{"date":331,"type":320},"2024-06-26",{"date":333,"type":320},"2022-08-26",{"date":335,"type":320},"2023-07-27",{"name":5,"class":6},27]