[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610462":3},{"organization":4,"outcomesModule":7,"designInfo":73,"detailedDescription":74,"studyPopulation":77,"armGroups":78,"interventions":74,"overallOfficials":82,"centralContacts":86,"locations":92,"responsibleParty":195,"collaborators":74,"id":197,"slug":198,"hasResults":199,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":199,"sex":205,"minAge":206,"maxAge":207,"enrollmentInfo":208,"targetDuration":74,"studyType":211,"phases":74,"briefSummary":212,"conditions":213,"keywords":215,"overallStatus":95,"whyStopped":74,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":225},{"fullName":5,"class":6},"AbbVie","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":46},[9],{"measure":10,"description":11,"timeFrame":12},"Change From Baseline in OFF Time (hours) as measured by modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) IV","The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD)","Up to approximately 6 months",[14,17,20,22,25,28,31,34,37,40,43],{"measure":15,"description":16,"timeFrame":12},"Change From Baseline in Dyskinesia presence as measured by modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) IV","The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). (The numeric score for each question is between 0-4; 0=Normal, 4=Severe)",{"measure":18,"description":19,"timeFrame":12},"Change From Baseline in Dyskinesia duration (absolute hours) as measured by modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) IV","The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD).",{"measure":21,"description":16,"timeFrame":12},"Change From Baseline in Motor complications as measured by modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) IV",{"measure":23,"description":24,"timeFrame":12},"Change From Baseline in Disease-specific Quality of Life (QoL) as measured by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index","The Parkinson's Disease Questionnaire (PDQ-39) is a disease-specific instrument designed to measure aspects of health that are relevant to participants with Parkinson's Disease (PD), and which may not be included in general health status questionnaires. Each item is scored on the following 5-point scale: 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, 4 = always (or cannot do at all, if applicable).",{"measure":26,"description":27,"timeFrame":12},"Change From Baseline in Generic Quality of Life (QoL) as measured by the EuroQol 5-Dimension Questionnaire (EQ-5D-5L)","The EuroQol 5-dimension questionnaire (EQ-5D-5L) is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain\u002Fdiscomfort, and anxiety\u002Fdepression) to describe the participant's current health state. Each item is scored from 1 (best) to 5 (worst). An increase in the EQ-5D-5L score indicates a worsening.",{"measure":29,"description":30,"timeFrame":12},"Change From Baseline in Motor experiences of daily living as measured by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)","The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). Part II assesses the participant's motor experiences of daily living (M-EDL) with 13 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part II scores range from 0 to 52, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement.",{"measure":32,"description":33,"timeFrame":12},"Change From Baseline in Disease-specific sleep disturbances as measured by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score","The PDSS-2 consists of 15 questions that evaluate motor and non-motor symptoms at night and upon wakening, as well as disturbed sleep grouped into 3 domains: motor symptoms at night (5 items), Parkinson's Disease (PD) symptoms at night (5 items), and disturbed sleep (5 items). The frequency is assessed for the 15 sleep problems based on a 5-point Likert-type scale (ranging from 0 \\[never\\] to 4 \\[very often\\] with the exception of Question 1 score ranging from 0 \\[very often\\] to 4 \\[never\\]).",{"measure":35,"description":36,"timeFrame":12},"Change From Baseline in Symptom severity measured by the Patient Global Impression of Severity (PGI-S)","The Patient Global Impression of Severity (PGI-S) is a single, patient-reported item that assesses the subject's perceived level of symptoms over the past 7 days. The measure uses a 5-point Likert rating scale with responses ranging from \"no symptoms\" (1) to \"very severe\" (5), with higher scores indicating greater severity.",{"measure":38,"description":39,"timeFrame":12},"Change From Baseline in Symptom severity measured by the Patient Global Impression of Change (PGI-C)","The Patient Global Impression of Change (PGI-C)is a 7-point response scale. The participant was asked by the Investigator or qualified designee to rate their change in status using the following 7-point scale: Scores range from 1 = Very much improved; to 7 = Very much worse.",{"measure":41,"description":42,"timeFrame":12},"Change From Baseline in Symptom severity measured by the Clinical Global Impression of Severity (CGI-S) scores","Clinical Global Impression of Severity (CGI-S) is a 7-point rating scale used to measure the that requires the clinician to assess how much the participant's illness has improved or worsened relative to the baseline state at the beginning of the intervention. Scores range from 1=normal; to 7=among the most extremely ill.",{"measure":44,"description":45,"timeFrame":12},"Change From Baseline in Symptom severity measured by the Clinical Global Impression of Change (CGI-C) scores","The Clinical Global Impression of Change (CGI-C) is a clinician's impression of a subject's change in status on a 7-point scale. CGI-C scores range from 1 = very much improved to 7 = very much worse.",[47,50,53,56,59,62,64,67,70],{"measure":48,"description":49,"timeFrame":12},"Change From Baseline in morning akinesia (early morning \"off\") as measured by by dedicated questionnaire.","Measured by dedicated questionnaire.",{"measure":51,"description":52,"timeFrame":12},"Change From Baseline in Activities of daily living\u002Findependence as measured by the Schwab-England Activities of Daily Living Scale (SE-ADL)","Schwab-England Activities of Daily Living Scale (SE-ADL) onsists of ten items intended to evaluate the daily life activities of a participant. The SEADL is composed of two sections: the first is a self-reported questionnaire in which participants grade their own daily life activities, such as dressing, using the toilet, resting, eating, and social activities (subjective assessment), and the second is an assessment of motor functions, such as postural balance, speaking, rigidity, and tremors, conducted by a clinician (objective assessment). It is a percentage scale divided into deciles, and the results are reported between 0% (bedridden) and 100% (healthy). Negative changes in values indicate a decline in health.",{"measure":54,"description":55,"timeFrame":12},"Change From Baseline in Self-efficacy as measured by the Self-efficacy for Managing Chronic Disease Scale (SEMCD)","Self-efficacy for Managing Chronic Disease Scale (SEMCD) Self-efficacy for chronic disease will be measured.",{"measure":57,"description":58,"timeFrame":12},"Change From Baseline in Ability to reintegrate into normal social activity after illness as measured by the Reintegration to Normal Living Scale (RNLI) Scale","Reintegration to Normal Living Scale (RNLI) Scale the reintegrate into normal social activity after illness will be measured",{"measure":60,"description":61,"timeFrame":12},"Change From Baseline in Treatment satisfaction, as measured by the Treatment Satisfaction Questionnaire for Medication, 9-Item Version Score (TSQM-9)","Treatment Satisfaction Questionnaire for Medication, 9-Item Version Score. an instrument to show that adherence is expected to be related with participants' satisfaction with therapy and that such satisfaction can be a function of not only the effect of the treatment, but also the services offered. Range of the domain scores range from 0 to 100 with higher scores indicating a better state or outcome (e.g., greater perceived effectiveness or satisfaction).",{"measure":63,"description":24,"timeFrame":12},"Change From Baseline in Stigma as measured by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index",{"measure":65,"description":66,"timeFrame":12},"Number of Participants who used Healthcare Resource Utilization (HRU)","Healthcare Resource Utilization (HRU) is measured from initiation of the studied line of therapy and captures .. eg physician visits, hospital stays and engagement with other supporting therapists.",{"measure":68,"description":69,"timeFrame":12},"Number of Participants achieving monotherapy with Foslevodopa\u002FFoscarbidopa (LDp\u002FCDp)","Percentage of patients achieving monotherapy with LDp\u002FCDp at month 3 and month 6",{"measure":71,"description":72,"timeFrame":12},"Questionnaire to investigate the practicalities of the infusion system","Questionnaire to investigate the practicalities of the infusion system e.g., vial consumption, frequency of infusion-site rotation, nighttime dose adjustments) will be measured",{"allocation":74,"interventionModel":74,"interventionModelDescription":74,"primaryPurpose":74,"observationalModel":75,"timePerspective":76,"maskingInfo":74},null,"COHORT","PROSPECTIVE","Participants with earlier within advanced Parkinson disease receiving Foslevodopa\u002FFoscarbidopa treatment in accordance with the local label requirements in the participating country.",[79],{"label":80,"type":74,"description":81,"interventionNames":74},"Foslevodopa\u002FFoscarbidopa","Participants will receive Foslevodopa\u002FFoscarbidopa as prescribed by their physician according to local label.",[83],{"name":84,"affiliation":5,"role":85},"ABBVIE INC.","STUDY_DIRECTOR",[87],{"name":88,"role":89,"phone":90,"phoneExt":74,"email":91},"Lars Bergmann","CONTACT","+49(0)170 4538568","lars.bergmann@abbvie.com",[93,107,118,128,136,142,153,163,173,183],{"facility":94,"status":95,"city":96,"state":97,"zip":98,"country":99,"countryCode":100,"cosmosGeoPoint":101,"geoPoint":106,"contacts":74},"Texas Movement Disorder Specialists \u002FID# 278565","RECRUITING","Georgetown","Texas","78628","United States","US",{"type":102,"coordinates":103},"Point",[104,105],-97.67723,30.63269,{"lat":105,"lon":104},{"facility":108,"status":95,"city":109,"state":109,"zip":110,"country":111,"countryCode":112,"cosmosGeoPoint":113,"geoPoint":117,"contacts":74},"Shaare Zedek Medical Center \u002FID# 276209","Jerusalem","91031","Israel","IL",{"type":102,"coordinates":114},[115,116],35.21633,31.76904,{"lat":116,"lon":115},{"facility":119,"status":95,"city":120,"state":121,"zip":122,"country":111,"countryCode":112,"cosmosGeoPoint":123,"geoPoint":127,"contacts":74},"The Chaim Sheba Medical Center \u002FID# 276210","Ramat Gan","Tel Aviv","5265601",{"type":102,"coordinates":124},[125,126],34.81065,32.08227,{"lat":126,"lon":125},{"facility":129,"status":95,"city":121,"state":121,"zip":130,"country":111,"countryCode":112,"cosmosGeoPoint":131,"geoPoint":135,"contacts":74},"Tel Aviv Sourasky Medical Center \u002FID# 276212","6423906",{"type":102,"coordinates":132},[133,134],34.78057,32.08088,{"lat":134,"lon":133},{"facility":137,"status":95,"city":109,"state":74,"zip":138,"country":111,"countryCode":112,"cosmosGeoPoint":139,"geoPoint":141,"contacts":74},"Hadassah Medical Center-Hebrew University \u002FID# 276211","91120",{"type":102,"coordinates":140},[115,116],{"lat":116,"lon":115},{"facility":143,"status":95,"city":144,"state":144,"zip":145,"country":146,"countryCode":147,"cosmosGeoPoint":148,"geoPoint":152,"contacts":74},"Fundeni Clinical Institute \u002FID# 277490","Bucharest","022328","Romania","RO",{"type":102,"coordinates":149},[150,151],26.10626,44.43225,{"lat":151,"lon":150},{"facility":154,"status":95,"city":155,"state":156,"zip":157,"country":146,"countryCode":147,"cosmosGeoPoint":158,"geoPoint":162,"contacts":74},"Arcadia Spitale Si Centre Medicale \u002FId# 277525","Iași","Iaşi","700620",{"type":102,"coordinates":159},[160,161],27.6,47.16667,{"lat":161,"lon":160},{"facility":164,"status":95,"city":165,"state":166,"zip":167,"country":146,"countryCode":147,"cosmosGeoPoint":168,"geoPoint":172,"contacts":74},"Neurotim Med \u002FID# 277500","Timișoara","Timiș County","300724",{"type":102,"coordinates":169},[170,171],21.22571,45.75372,{"lat":171,"lon":170},{"facility":174,"status":175,"city":176,"state":74,"zip":177,"country":146,"countryCode":147,"cosmosGeoPoint":178,"geoPoint":182,"contacts":74},"Spitalul Clinic Judetean De Urgenta Brasov \u002FID# 277499","NOT_YET_RECRUITING","Brasov","500326",{"type":102,"coordinates":179},[180,181],25.60613,45.64861,{"lat":181,"lon":180},{"facility":184,"status":95,"city":185,"state":186,"zip":187,"country":188,"countryCode":189,"cosmosGeoPoint":190,"geoPoint":194,"contacts":74},"University Hospitals Plymouth NHS Trust \u002FID# 284977","Plymouth","Devon","PL6 8DH","United Kingdom","UK",{"type":102,"coordinates":191},[192,193],-4.14305,50.37153,{"lat":193,"lon":192},{"type":196,"investigatorFullName":74,"investigatorTitle":74,"investigatorAffiliation":74,"oldNameTitle":74,"oldOrganization":74},"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","P25-758 PUCCIN","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":209,"type":210},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",[214],"Parkinson's Disease",[214,80],"2026-08-28",{"date":218,"type":219},"2026-09-01","ACTUAL",{"date":221,"type":219},"2026-08-03",{"date":223,"type":210},"2027-10",{"name":5,"class":6},10]