[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609849":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":40,"studyPopulation":41,"armGroups":36,"interventions":42,"overallOfficials":47,"centralContacts":51,"locations":58,"responsibleParty":132,"collaborators":36,"id":134,"slug":36,"hasResults":135,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":36,"eligibilityCriteria":139,"healthyVolunteers":135,"sex":140,"minAge":141,"maxAge":36,"enrollmentInfo":142,"targetDuration":36,"studyType":145,"phases":36,"briefSummary":146,"conditions":147,"keywords":149,"overallStatus":61,"whyStopped":36,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},{"fullName":5,"class":6},"Supernus Pharmaceuticals, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":36},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Titration Duration and Time to Optimized Dose","The time from the date of ONAPGO™ initiation to the date of Dose Optimization Confirmation, as documented by the HCP\u002FInvestigator Unit of Measure: days","Approximately 52-60 weeks",{"measure":14,"description":15,"timeFrame":16},"Concomitant Parkinson's Disease (PD) Medication Adjustments","Percentage of participants requiring ≥1 adjustment to their concomitant PD medications, as documented by the HCP\u002FInvestigator. \"Percentage of participants\"","Approximately 52-60 week",{"measure":18,"description":19,"timeFrame":12},"The number of titration visits or dose adjustments required to reach the final optimized dose. This is a count of a specific event","Number of titration visits or infusion adjustments to reach final optimized dose; Unit of Measure: count per participant",[21,24,27,30,33],{"measure":22,"description":23,"timeFrame":12},"Perception of Patient Global Health Improvement","Change from baseline in the Patient Global Impression of Change (PGI-C) scale, with scores ranging from 1 (\"very much improved\") to 7 (\"very much worse\"); lower scores indicate better outcomes. Unit of Measure: PGI-C score (range 1-7)",{"measure":25,"description":26,"timeFrame":12},"Caregiver Burden","Change from baseline in caregiver quality of life (QoL) as determined by scores on the European Quality of Life 5 Dimensions (EQ-5D) scale. This scale measures health-related QoL, with scores ranging from 0 (death) to 1 (full health). A higher score indicates a better outcome.",{"measure":28,"description":29,"timeFrame":12},"HCP\u002FInvestigator burden for ONAPGO providers","Change from baseline to each time point in scores over time on the modified 8-item HCP Burden Scale to assess the HCP perceived burden of managing patients on ONAPGO treatment",{"measure":31,"description":32,"timeFrame":12},"Evaluation of ONAPGO usage during the maintenance period","Hourly modal infusion rate (mg\u002Fhour) during the maintenance period Daily modal dose (mg\u002Fday) during the maintenance period Daily modal duration (hour) during the maintenance period",{"measure":34,"description":35,"timeFrame":12},"Safety by monitoring adverse events (AEs)","Safety is measured by AE evaluation according to the standard of care and the percentage of participants who discontinue ONAPGO™ treatment due to AEs",null,{"allocation":36,"interventionModel":36,"interventionModelDescription":36,"primaryPurpose":36,"observationalModel":38,"timePerspective":39,"maskingInfo":36},"COHORT","PROSPECTIVE","This observational study includes an Enrollment Day (participants enrolled any time between their prescription for the infusion and ONAPGO initiation); a Baseline Period (prior to ONAPGO initiation which includes in-home education on the use of ONAPGO by the Clinical Nurse Navigator \\[CNN\\] according to standard practice for patients with PD-prescribed ONAPGO); Dose Initiation, Titration, and Optimization per Prescription Periods; a Maintenance Period; Maintenance CNN standard of care visits; and an End-of-Study (EOS)\u002FDiscontinuation Visit.","Participants are eligible for participation in this study after they have received a prescription for Onapgo",[43],{"type":44,"name":45,"description":46,"armGroupLabels":36,"otherNames":36},"OTHER","Observational study","Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM)",[48],{"name":49,"affiliation":5,"role":50},"Mindy Grall, PhD ANP-BC","STUDY_CHAIR",[52,56],{"name":49,"role":53,"phone":54,"phoneExt":36,"email":55},"CONTACT","18663980833","mgrall@supernus.com",{"name":57,"role":53,"phone":54,"phoneExt":36,"email":36},"Supernus Supernus",[59,78,91,104,118],{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Parkinson's Disease and Movement Disorders Center - Orange County (South)","RECRUITING","Aliso Viejo","California","92656","United States","US",{"type":68,"coordinates":69},"Point",[70,71],-117.72712,33.56504,{"lat":71,"lon":70},[74,76],{"name":75,"role":53,"phone":36,"phoneExt":36,"email":36},"Mindy Bixby, D.O.",{"name":75,"role":77,"phone":36,"phoneExt":36,"email":36},"PRINCIPAL_INVESTIGATOR",{"facility":79,"status":61,"city":80,"state":63,"zip":81,"country":65,"countryCode":66,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Parkinson's Disease and Movement Disorders Center - Orange County (North)","Irvine","92618",{"type":68,"coordinates":83},[84,85],-117.82311,33.66946,{"lat":85,"lon":84},[88,90],{"name":89,"role":53,"phone":36,"phoneExt":36,"email":36},"Sandeep Thakkar, D.O.",{"name":89,"role":77,"phone":36,"phoneExt":36,"email":36},{"facility":92,"status":61,"city":93,"state":63,"zip":94,"country":65,"countryCode":66,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Parkinson's Research Centers of America - Palo Alto","Palo Alto","94301",{"type":68,"coordinates":96},[97,98],-122.14302,37.44188,{"lat":98,"lon":97},[101,103],{"name":102,"role":53,"phone":36,"phoneExt":36,"email":36},"Salima Brillman, MD",{"name":102,"role":77,"phone":36,"phoneExt":36,"email":36},{"facility":105,"status":61,"city":106,"state":107,"zip":108,"country":65,"countryCode":66,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Parkinson's Disease & Movement Disorders Center of Boca Raton","Boca Raton","Florida","33486",{"type":68,"coordinates":110},[111,112],-80.0831,26.35869,{"lat":112,"lon":111},[115,117],{"name":116,"role":53,"phone":36,"phoneExt":36,"email":36},"Stuart Isaacson, MD",{"name":116,"role":77,"phone":36,"phoneExt":36,"email":36},{"facility":119,"status":61,"city":120,"state":121,"zip":122,"country":65,"countryCode":66,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Parkinson's Disease and Movement Disorders Center - Long Island","Commack","New York","11725",{"type":68,"coordinates":124},[125,126],-73.29289,40.84288,{"lat":126,"lon":125},[129,131],{"name":130,"role":53,"phone":36,"phoneExt":36,"email":36},"David Kreitzman, M.D.",{"name":130,"role":77,"phone":36,"phoneExt":36,"email":36},{"type":133,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100609849",false,"NCT07219927","Real-World Patient Experiences Using Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM) in the United States:","Real-World Patient Experiences Using Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM) in the United States: A Prospective, Phase 4, Multicenter, Observational Study in Parkinson's Disease","Inclusion Criteria:\n\nParticipant has received a prescription for ONAPGO™ according to the standard of care.\n\nParticipant has opted into receiving support services from the Clinical Nurse Navigator (CNN), a registered nurse specially trained to work with persons with Parkinson's disease, as noted on the Prescription Enrollment Form.\n\nThe HCP\u002FInvestigator determines the participant is an appropriate study participant.\n\nParticipant is able and willing to provide informed consent (or informed assent form \\[IAF\\], as applicable) and signs the consent form on the Enrollment Day.\n\nExclusion Criteria:\n\nDid not receive a prescription for ONAPGO™.\n\nPrescribed ONAPGO™, but the HCP\u002FInvestigator determines the participant should not participate in this observational study.\n\nConcomitant use of ONAPGO™ with 5-HT3 antagonists, including antiemetics (e.g., ondansetron, granisetron, dolasetron, palonosetron) or alosetron.\n\nKnown hypersensitivity to apomorphine or to excipients of ONAPGO™, including sulfite (e.g., sodium metabisulfite).","ALL","18 Years",{"count":143,"type":144},120,"ESTIMATED","OBSERVATIONAL","Real-World Participants Experiences Using Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM) in the United States: A Prospective, Phase 4, Multicenter, Observational Study in Parkinson's Disease",[148],"Parkinson Disease",[150],"ONAPGO","2025-10-21",{"date":153,"type":154},"2025-10-22","ACTUAL",{"date":156,"type":154},"2025-03-31",{"date":158,"type":144},"2027-08-01",{"name":5,"class":6},5]