[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610462":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":16,"locations":22,"responsibleParty":36,"collaborators":10,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":40,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":10,"studyType":52,"phases":10,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":57,"whyStopped":10,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},{"fullName":5,"class":6},"AbbVie","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Foslevodopa\u002FFoscarbidopa",null,"Participants will receive Foslevodopa\u002FFoscarbidopa as prescribed by their physician according to local label.",[13],{"name":14,"affiliation":5,"role":15},"ABBVIE INC.","STUDY_DIRECTOR",[17],{"name":18,"role":19,"phone":20,"phoneExt":10,"email":21},"Lars Bergmann","CONTACT","+49(0)170 4538568","lars.bergmann@abbvie.com",[23],{"facility":24,"status":10,"city":25,"state":26,"zip":27,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":10},"Boston Medical Center Health System","Boston","Massachusetts","02118","United States","US",{"type":31,"coordinates":32},"Point",[33,34],-71.05977,42.35843,{"lat":34,"lon":33},{"type":37,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100610462","real-world-study-of-foslevodopafoscarbidopa-to-assess-quality-of-life-outcomes-in-adult-participants-earlier-within-advanced-parkinson-disease-100610462",false,"NCT07227896","Real-World Study of Foslevodopa\u002FFoscarbidopa to Assess Quality of Life Outcomes in Adult Participants Earlier Within Advanced Parkinson Disease","A Global Real-World Evidence Study on the Effectiveness and Safety\u002FTolerability of Foslevodopa\u002FFoscarbidopa in Patients Earlier Within Advanced Parkinson's Disease","PUCCINI","Inclusion Criteria:\n\n* Eligibility for Foslevodopa\u002FFoscarbidopa (LDp\u002FCDp) therapy in accordance with approved local label in the participating country and local reimbursement regulations, if applicable\n* A diagnosis of levodopa-responsive idiopathic Parkinson's Disease (PD)\n* Adult male or female between 18 and 80 years of age\n* Disease duration (time since diagnosis) \\\u003C10 years\n* Time since motor fluctuations ≤3 years\n* H\\&Y Stage \\\u003C3 in best \"on\"\n* \"off\" time of 2.5-6 hours per day\n* Naïve to LDp\u002FCDp\n* Treatment has been optimized with oral\u002Ftransdermal PD medication in the opinion of the Investigator\n* Decision to treat with LDp\u002FCDp made by the clinician prior to any decision to approach the participant to participate in the study\n* Willing and able to comply with procedures required during this study, specifically with entering data and filling questionnaires in an electronic device (tablet).\n* Prior to any study-related procedures being performed, the participant or Legal Authorized Representative (LAR) must voluntarily sign an Authorization for Use\u002FDisclosure of Data (AUDD)\u002FInformed Consent Form (ICF) according to national regulations once the study has been explained and the participant has the opportunity to have any questions answered\n\nExclusion Criteria:\n\n* History of any condition included in the contraindications section of the approved local Foslevodopa\u002FFoscarbidopa (LDp\u002FCDp) label in the participating country\n* History of treatment with any Device-Aided Therapy (DAT), such as Deep Brain Stimulation (DBS), Continuous Subcutaneous Apomorphine Infusion (CSAI), Levodopa\u002FCarbidopa Intestinal Gel (LCIG)\u002F Carbidopa\u002FLevodopa Enteral Suspension (CLES), Levodopa\u002FEntacapone\u002FCarbidopa Intestinal Gel (LECIG)\n* Mini-Mental State Examination (MMSE) score \\\u003C24\n* Participation in a concurrent investigational or observational clinical trial\n* Lack of motivation\u002Finsufficient language skills to complete the study questionnaires\n* History of significant skin conditions or disorders (e.g., psoriasis, atopic dermatitis). In case of temporary affections like recent sunburn or open wounds, or in case of permanent affections like acne, scar tissue, tattoo, branding, or colorations, the participant should not be included if the Investigator considers these as interfering with infusion of study drug or study assessments.","ALL","18 Years","80 Years",{"count":50,"type":51},100,"ESTIMATED","OBSERVATIONAL","Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. This study will assess how effective Foslevodopa\u002FFoscarbidopa is in treating adult participants earlier within advanced Parkinson disease under routine clinical practice.\n\nFoslevodopa\u002FFoscarbidopa is an approved drug for the treatment of Parkinson's Disease. Approximately 100 adult participants who are prescribed Foslevodopa\u002FFoscarbidopa by their doctors will be enrolled across approximately 40 sites across the world.\n\nParticipants will receive Foslevodopa\u002FFoscarbidopa subcutaneous infusion as prescribed by their physician. Participants will be followed for up to 6 months.\n\nThere are no additional examinations due to the study but the participants and caregivers will need to fill several questionnaires to generate data on their motor function and well-being",[55],"Parkinson's Disease",[55,9],"NOT_YET_RECRUITING","2026-02-12",{"date":60,"type":61},"2026-02-17","ACTUAL",{"date":63,"type":51},"2026-03-01",{"date":65,"type":51},"2027-10",{"name":5,"class":6},1]