[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653068":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":11,"studyPopulation":11,"armGroups":35,"interventions":51,"overallOfficials":58,"centralContacts":62,"locations":11,"responsibleParty":70,"collaborators":11,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":11,"studyType":86,"phases":87,"briefSummary":90,"conditions":91,"keywords":11,"overallStatus":93,"whyStopped":11,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":11},{"fullName":5,"class":6},"Hoffmann-La Roche","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Time to a Confirmed Motor Progression Event From the Randomization Date, as Measured by the MDS-UPDRS Part III Score",null,"Up to at least Week 104",[14,17,19,21,23],{"measure":15,"description":11,"timeFrame":16},"Change in Motor Signs From Baseline at Week 104, as Measured by the MDS-UPDRS Part III Score","Baseline and Week 104",{"measure":18,"description":11,"timeFrame":12},"Time to Worsening of Participants' Motor Function, as Reported by the Participant in the Presence of a Confirmed Motor Progression Event",{"measure":20,"description":11,"timeFrame":12},"Incidence of Adverse Events (AEs)",{"measure":22,"description":11,"timeFrame":12},"Change From Baseline in Columbia-suicide Severity Rating Scale (C-SSRS)",{"measure":24,"description":11,"timeFrame":12},"Plasma Concentrations of RO7568282",{"allocation":26,"interventionModel":27,"interventionModelDescription":11,"primaryPurpose":28,"observationalModel":11,"timePerspective":11,"maskingInfo":29},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":30,"maskingDescription":31,"whoMasked":32},"DOUBLE","The Sponsor will also be blinded to treatment assignments.",[33,34],"PARTICIPANT","INVESTIGATOR",[36,42,45],{"label":37,"type":38,"description":39,"interventionNames":40},"RO7568282 High Dose","EXPERIMENTAL","RO7568282 will be administered as per the schedule specified in the protocol.",[41],"Drug: RO7568282",{"label":43,"type":38,"description":39,"interventionNames":44},"RO7568282 Low Dose",[41],{"label":46,"type":47,"description":48,"interventionNames":49},"Placebo","PLACEBO_COMPARATOR","Placebo will be administered as per the schedule specified in the protocol.",[50],"Drug: Placebo",[52,56],{"type":53,"name":54,"description":39,"armGroupLabels":55,"otherNames":11},"DRUG","RO7568282",[37,43],{"type":53,"name":46,"description":48,"armGroupLabels":57,"otherNames":11},[46],[59],{"name":60,"affiliation":5,"role":61},"Clinical Trials","STUDY_DIRECTOR",[63,68],{"name":64,"role":65,"phone":66,"phoneExt":11,"email":67},"Reference Study ID Number: BP46441 https:\u002F\u002Fforpatients.roche.com\u002F No email attachments.","CONTACT","888-662-6728","global-roche-genentech-trials@gene.com",{"name":69,"role":65,"phone":11,"phoneExt":11,"email":11},"Fastest response: use the inquiry form. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",{"type":71,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100653068","phase-1-study-to-test-effects-and-safety-of-ro7568282-in-early-parkinsons-disease-100653068",false,"NCT07781644","Study to Test Effects and Safety of RO7568282 in Early Parkinson's Disease","A Phase II, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of RO7568282 in Participants With Early-stage Parkinson's Disease","TARBELA-PD","Inclusion Criteria:\n\n* Must be aged 40 to 85 years inclusive\n* Diagnosis of idiopathic PD\n* Has received stable doses of monotherapy treatment with levodopa for at least 2 months prior to baseline\n* Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV score of 0 at screening and prior to randomization at baseline\n* Hoehn and Yahr (H\\&Y) Stage ≤ 3 (assessed in off medication state) at screening and prior to randomization at baseline\n* Able to swallow whole capsules\n\nExclusion Criteria:\n\n* Medical history indicating a parkinsonian syndrome other than idiopathic PD\n* Diagnosis of PD dementia\n* Diagnosis of a significant neurologic disease other than PD\n* Within the last year, unstable or clinically significant cardiovascular disease\n* Chronic uncontrolled hypertension\n* History or presence of brain magnetic resonance imaging (MRI) scan showing evidence of structural abnormalities, other than related to PD\n\nNote: Other protocol-defined inclusion\u002Fexclusion criteria also apply","ALL","40 Years","85 Years",{"count":84,"type":85},474,"ESTIMATED","INTERVENTIONAL",[88,89],"PHASE1","PHASE2","The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of RO7568282 compared with placebo in participants with early-stage Parkinson's disease (PD) on stable symptomatic monotherapy with levodopa.",[92],"Parkinson's Disease","NOT_YET_RECRUITING","2026-09-18",{"date":96,"type":97},"2026-09-21","ACTUAL",{"date":99,"type":85},"2026-09-30",{"date":101,"type":85},"2032-04-15",{"name":5,"class":6}]