[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591118":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":33,"studyPopulation":33,"armGroups":45,"interventions":59,"overallOfficials":33,"centralContacts":71,"locations":77,"responsibleParty":228,"collaborators":33,"id":230,"slug":33,"hasResults":231,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":33,"eligibilityCriteria":235,"healthyVolunteers":231,"sex":236,"minAge":237,"maxAge":238,"enrollmentInfo":239,"targetDuration":33,"studyType":242,"phases":243,"briefSummary":246,"conditions":247,"keywords":249,"overallStatus":80,"whyStopped":33,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":264},{"fullName":5,"class":6},"Biohaven Pharmaceuticals, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":33},[9],{"measure":10,"description":11,"timeFrame":12},"Time to first qualifying worsening event on Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II","To evaluate the efficacy of BHV-8000 compared to placebo. This objective is measured by assessing the time to prespecified worsening on MDS-UPDRS Part II (motor experiences of daily living per self-administered questionnaire). MDS-UPDRS Part II is a 52-point scale with a higher total score representing more severe disability.","Up to 48 Weeks",[14,18,21,24,27,30],{"measure":15,"description":16,"timeFrame":17},"Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III from Baseline to Week 48","To evaluate the efficacy of BHV-8000 compared to placebo. This objective is measured by assessing the change in MDS-UPDRS Part III (motor examination conducted by rater). MDS-UPDRS Part III is a 132-point scale with a higher total score representing a greater degree of motor impairment.","Baseline to Week 48",{"measure":19,"description":20,"timeFrame":17},"Change in Clinical Global Impression of Severity (CGI-S) from Baseline to Week 48","To evaluate the efficacy of BHV-8000 compared to placebo. This objective is measured by assessing the change in severity of a participant's illness as determined by the managing clinician. The CGI-S is a 7-point scale (1 - 7) with 7 representing the most extremely ill participants.",{"measure":22,"description":23,"timeFrame":17},"Change in DaT-SPECT scan from Baseline to Week 48","To evaluate the efficacy of BHV-8000 compared to placebo. This objective is measured by change in DaT-SPECT Striatal Binding Ratio (SBR) in the putamen (assessing the activity of the dopamine transporters). Reduced uptake of the radiotracer is indicative of a decreased number of dopamine-secreting cells and suggestive of disease progression.",{"measure":25,"description":26,"timeFrame":17},"Change in Parkinson's Disease Composite Score - Function (PARCOMS-Function) from Baseline to Week 48","To compare the efficacy of BHV-8000 compared to placebo. This objective is measured by changes in the Parkinson's Disease Composite Score - Function (PARCOMS-Function) score. The PARCOMS-Function is a composite of select items taken from the MDS-UPDRS Part II and the PDQ-39© (assessing ability to complete daily activities). The PARCOMS-Function is a 100-point scale (0 - 100) with higher scores representing greater dysfunction.",{"measure":28,"description":29,"timeFrame":17},"Number of Participants with Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs","To assess the safety and tolerability of BHV-8000. This objective will be measured by assessing the number of unique participants with deaths, SAEs, AEs leading to discontinuation, and moderate and severe AEs.",{"measure":31,"description":32,"timeFrame":17},"Number of participants with clinically significant laboratory abnormalities","To assess the safety and tolerability of BHV-8000. This objective will be measured by assessing the number of unique participants with treatment-emergent Grade 3 and 4 laboratory abnormalities.",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":33,"primaryPurpose":37,"observationalModel":33,"timePerspective":33,"maskingInfo":38},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":39,"maskingDescription":33,"whoMasked":40},"QUADRUPLE",[41,42,43,44],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[46,51,54],{"label":47,"type":48,"description":33,"interventionNames":49},"BHV-8000 10 mg","EXPERIMENTAL",[50],"Drug: BHV-8000",{"label":52,"type":48,"description":33,"interventionNames":53},"BHV-8000 20 mg",[50],{"label":55,"type":56,"description":33,"interventionNames":57},"Placebo","PLACEBO_COMPARATOR",[58],"Drug: Placebo",[60,65,68],{"type":61,"name":62,"description":63,"armGroupLabels":64,"otherNames":33},"DRUG","BHV-8000","BHV-8000 10 mg. Participants will take blinded investigational product (IP) once daily",[47],{"type":61,"name":62,"description":66,"armGroupLabels":67,"otherNames":33},"BHV-8000 20 mg. Participants will take blinded investigational product (IP) once daily",[52],{"type":61,"name":55,"description":69,"armGroupLabels":70,"otherNames":33},"Matching placebo taken once daily",[55],[72],{"name":73,"role":74,"phone":75,"phoneExt":33,"email":76},"Chief Medical Officer","CONTACT","203-404-0410","clinicaltrials@biohavenpharma.com",[78,92,102,112,121,131,140,149,159,169,179,189,198,208,218],{"facility":79,"status":80,"city":81,"state":82,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":33},"Site-049","RECRUITING","Birmingham","Alabama","35294","United States","US",{"type":87,"coordinates":88},"Point",[89,90],-86.80249,33.52066,{"lat":90,"lon":89},{"facility":93,"status":80,"city":94,"state":95,"zip":96,"country":84,"countryCode":85,"cosmosGeoPoint":97,"geoPoint":101,"contacts":33},"Site-041","Los 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Raton","33486",{"type":87,"coordinates":136},[137,138],-80.0831,26.35869,{"lat":138,"lon":137},{"facility":141,"status":80,"city":142,"state":124,"zip":143,"country":84,"countryCode":85,"cosmosGeoPoint":144,"geoPoint":148,"contacts":33},"Site-051","Maitland","32751",{"type":87,"coordinates":145},[146,147],-81.36312,28.62778,{"lat":147,"lon":146},{"facility":150,"status":80,"city":151,"state":152,"zip":153,"country":84,"countryCode":85,"cosmosGeoPoint":154,"geoPoint":158,"contacts":33},"Site-027","Chicago","Illinois","60611",{"type":87,"coordinates":155},[156,157],-87.65005,41.85003,{"lat":157,"lon":156},{"facility":160,"status":80,"city":161,"state":162,"zip":163,"country":84,"countryCode":85,"cosmosGeoPoint":164,"geoPoint":168,"contacts":33},"Site-071","Boston","Massachusetts","02114",{"type":87,"coordinates":165},[166,167],-71.05977,42.35843,{"lat":167,"lon":166},{"facility":170,"status":80,"city":171,"state":172,"zip":173,"country":84,"countryCode":85,"cosmosGeoPoint":174,"geoPoint":178,"contacts":33},"Site-015","Farmington Hills","Michigan","48334",{"type":87,"coordinates":175},[176,177],-83.37716,42.48531,{"lat":177,"lon":176},{"facility":180,"status":80,"city":181,"state":182,"zip":183,"country":84,"countryCode":85,"cosmosGeoPoint":184,"geoPoint":188,"contacts":33},"Site-044","Chesterfield","Missouri","63005",{"type":87,"coordinates":185},[186,187],-90.57707,38.66311,{"lat":187,"lon":186},{"facility":190,"status":80,"city":191,"state":191,"zip":192,"country":84,"countryCode":85,"cosmosGeoPoint":193,"geoPoint":197,"contacts":33},"Site-005","New York","10021",{"type":87,"coordinates":194},[195,196],-74.00597,40.71427,{"lat":196,"lon":195},{"facility":199,"status":80,"city":200,"state":201,"zip":202,"country":84,"countryCode":85,"cosmosGeoPoint":203,"geoPoint":207,"contacts":33},"Site-091","Portland","Oregon","97210",{"type":87,"coordinates":204},[205,206],-122.67621,45.52345,{"lat":206,"lon":205},{"facility":209,"status":80,"city":210,"state":211,"zip":212,"country":84,"countryCode":85,"cosmosGeoPoint":213,"geoPoint":217,"contacts":33},"Site-043","Round Rock","Texas","78681",{"type":87,"coordinates":214},[215,216],-97.6789,30.50826,{"lat":216,"lon":215},{"facility":219,"status":80,"city":220,"state":221,"zip":222,"country":84,"countryCode":85,"cosmosGeoPoint":223,"geoPoint":227,"contacts":33},"Site-007","Bellevue","Washington","98007",{"type":87,"coordinates":224},[225,226],-122.20068,47.61038,{"lat":226,"lon":225},{"type":229,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100591118",false,"NCT06976268","A Study to Determine if BHV-8000 is Effective, Safe and Tolerable as a Treatment for Adults Living With Early Parkinson's Disease","A Phase 2\u002F3, Double-Blind, Placebo-Controlled Study of BHV-8000 in Participants With Early Parkinson's Disease","Key Inclusion Criteria:\n\n* Male or female participants 40 to 85 years of age, inclusive, at the time of informed consent.\n* Meet the diagnostic criteria for \"Probable PD\" as assessed on the Movement Disorder Society (MDS) Clinical Diagnostic Criteria for PD as assessed by the Investigator.\n* Have a clinician-documented diagnosis of idiopathic PD with an onset within 2 years of the Screening Visit\n\nKey Exclusion Criteria:\n\n* Medical history indicating a Parkinsonian syndrome other than idiopathic PD, including, but not limited to, progressive supranuclear gaze palsy, multiple system atrophy, drug-induced Parkinsonism, essential tremor, or primary dystonia.\n* Diagnosis of clinically significant central nervous system (CNS) disease other than PD.\n* Participants who are current smokers (defined as smoking \\[in any form, e.g., tobacco smoke, electronic cigarettes, etc.\\] )\n* Treatment with PD medication(s)\n* Any other condition(s) that may compromise participant safety, interfere with study conduct, or jeopardize the potential proper interpretation of study results, in the opinion of the investigator.","ALL","40 Years","85 Years",{"count":240,"type":241},550,"ESTIMATED","INTERVENTIONAL",[244,245],"PHASE2","PHASE3","A study to determine if BHV-8000 is efficacious, safe and tolerable in adults diagnosed with early Parkinson's disease.",[248],"Parkinson Disease",[250,251,252,253],"Early Parkinson's Disease","Parkinson's Disease","Early onset Parkinson's Disease","treatment naiive early Parkinson's Disease","2026-01-13",{"date":256,"type":257},"2026-01-14","ACTUAL",{"date":259,"type":257},"2025-05-28",{"date":261,"type":241},"2027-09",{"name":263,"class":6},"Biohaven Therapeutics Ltd.",15]