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Recruiting
NCT07138560
BOOST-PD A Naturalistic Study on IPX-203 for Parkinson's Disease
Conditions: Parkinson Disease
Sex: All
Ages: 40 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 22
Sponsor: The Cleveland Clinic
Location: Cleveland Clinic Cleveland Ohio
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* \- Participant is 40 years or older
* Diagnosed with idiopathic Parkinson's disease and is deemed to be levodopa responsive
* Baseline MDS-UPDRS score in OFF-state is \> 20
* Patient is being treated with a stable regimen of CD-LD for at least four weeks
* 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
* Participant can be on stable doses of any levodopa adjunctive medications and/or psychotropic medications for at least 30 days
* Participant experiences off time estimated at 2 hours or more per day; participant can comply with the wearable kinematic device.
Exclusion Criteria:
* \- Participants with severe dyskinesia as defined by a score of 4 on Question 4.1 (time spent with dyskinesia) of UPDRS IV
* Currently on device-aided therapies for advanced PD
* Using controlled-release CD-LD apart from a single daily bedtime dose
* Using "on demand" therapy unless willing to stop it during the study period
* Have a diagnosis hypothesis of dopamine dysregulation syndrome or evidence of significant levodopa-related complications including orthostatic hypotension or psychosis
* History of dementia or MOCA score lower than 23
* Significant medical history might interfere significantly with study participation
* Being enrolled in other clinical trials involving active medication interventions.
Source: ClinicalTrials.gov (NCT07138560). StuddyBuddy aggregates publicly available trial information.