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
The Cleveland Clinic
22 participants
Jul 24, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- \- 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 Criteria8
- \- 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.
Interventions
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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07138560