NCT07138560RecruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 22 (estimated)
- First submitted
- 15 May 2025
- Start date
- 24 Jul 2025
- Primary completion date
- 15 Feb 2027
- Lead sponsor
- The Cleveland Clinic
- Diseases
- Parkinson disease
- NCT number
- NCT07138560
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 22
- From 24 Jul 2025 to the primary completion date, 15 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
Other
- \- 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
Who the study is looking for
- \- 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.
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.