[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603595":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":21,"centralContacts":25,"locations":36,"responsibleParty":51,"collaborators":54,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":30,"enrollmentInfo":68,"targetDuration":30,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":39,"whyStopped":30,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"The Cleveland Clinic","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Intervention Arm","The intervention arm will be patients converting to shorter dose intervals of Crexont (IPX203) and allowing for higher dosing frequency, as practiced in real-world settings, combined with objective monitoring of on-time periods and other parameters using the KinesiaU device, could reveal additional benefits of Crexont (IPX203) treatment.",[12],"Drug: CREXONT ER",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","CREXONT ER","exploring shorter dose intervals of Crexont (IPX203) and allowing for higher dosing frequency, as practiced in real-world settings, combined with objective monitoring of on-time periods",[9],[20],"IPX203",[22],{"name":23,"affiliation":5,"role":24},"Hubert Fernandez, MD","PRINCIPAL_INVESTIGATOR",[26,32],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Saar Anis, MD","CONTACT","216 678-8896",null,"ANISS2@ccf.org",{"name":33,"role":28,"phone":34,"phoneExt":30,"email":35},"Mary Carmell Beukemann","216-372-2867","beukemm@ccf.org",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":30},"Cleveland Clinic","RECRUITING","Cleveland","Ohio","44195","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-81.69541,41.4995,{"lat":49,"lon":48},{"type":24,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Hubert Fernandez","Center Director",[55],{"name":56,"class":57},"Amneal Pharmaceuticals, LLC","INDUSTRY","100603595","phase-4-boost-pd-a-naturalistic-study-on-ipx-203-for-parkinsons-disease-100603595",false,"NCT07138560","BOOST-PD A Naturalistic Study on IPX-203 for Parkinson's Disease","BOOST-PD - Better On-time Observations of Motor Fluctuations Using Wearable Sensor Technology: A Naturalistic Study on IPX-203 for Parkinson's Disease","BOOST-PD","Inclusion Criteria:\n\n* \\- Participant is 40 years or older\n* Diagnosed with idiopathic Parkinson's disease and is deemed to be levodopa responsive\n* Baseline MDS-UPDRS score in OFF-state is \\> 20\n* Patient is being treated with a stable regimen of CD-LD for at least four weeks\n* The minimum most frequent levodopa dosing is 100 mg if using IR CD-LD and 195mg if using Rytary; maximum levodopa dosing per day is 1200 mg if using IR CD-LD, 1000 mg if associated with a COMT inhibitor, and 2400 mg if using Rytary\n* Participant can be on stable doses of any levodopa adjunctive medications and\u002For psychotropic medications for at least 30 days\n* Participant experiences off time estimated at 2 hours or more per day; participant can comply with the wearable kinematic device.\n\nExclusion Criteria:\n\n* \\- Participants with severe dyskinesia as defined by a score of 4 on Question 4.1 (time spent with dyskinesia) of UPDRS IV\n* Currently on device-aided therapies for advanced PD\n* Using controlled-release CD-LD apart from a single daily bedtime dose\n* Using \"on demand\" therapy unless willing to stop it during the study period\n* Have a diagnosis hypothesis of dopamine dysregulation syndrome or evidence of significant levodopa-related complications including orthostatic hypotension or psychosis\n* History of dementia or MOCA score lower than 23\n* Significant medical history might interfere significantly with study participation\n* Being enrolled in other clinical trials involving active medication interventions.","ALL","40 Years",{"count":69,"type":70},22,"ESTIMATED","INTERVENTIONAL",[73],"PHASE4","The purpose of this study is to evaluate the effect of IPX203 (Crexont®) - the newest extended-release levodopa formulation - on the duration and quality of good on time, using a wearable device to monitor symptoms. 'Good on time' refers to a period (minutes to hours) when a patient experiences optimal symptom control due to effective medication and has better overall functioning without troublesome dyskinesias. The change in the duration and quality of on-time will be measured by a wearable device placed on your wrist called KinesiaU.",[76],"Parkinson Disease",[78,79],"Crexont","motor fluctuations","2026-06-18",{"date":82,"type":83},"2026-06-23","ACTUAL",{"date":85,"type":83},"2025-07-24",{"date":87,"type":70},"2027-05-15",{"name":5,"class":6},1]