Tests Crexont in people with Parkinson's disease using a wrist sensor
Tests Crexont, a levodopa medicine, in adults with Parkinson's disease over time.
Plain-language title generated from the registry record
Registry title: BOOST-PD A Naturalistic Study on IPX-203 for Parkinson's Disease
Key facts
- Where
- Cleveland, United StatesSee the site
- Phase
- Phase 4
Where in United States
- Cleveland ClinicCleveland, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The Cleveland Clinic
- Trial code
- NCT07138560
- Record updated
- 15 October 2026
- Original description
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.Read full original descriptionShow less
BOOST-PD - Better On-time Observations of Motor Fluctuations Using Wearable Sensor Technology: A Naturalistic Study on IPX-203 for Parkinson's Disease
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.
Inclusion: - 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: Currently on device-aided therapies for advanced PD; Using "on demand" therapy unless willing to stop it during the study period; Being enrolled in other clinical trials involving active medication interventions; 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; - Participants with severe dyskinesia as defined by a score of 4 on Question 4.1 (time spent with dyskinesia) of UPDRS IV; Using controlled-release CD-LD apart from a single daily bedtime dose; Significant medical history might interfere significantly with study participation.