Status:
RECRUITING
BOOST-PD A Naturalistic Study on IPX-203 for Parkinson's Disease
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
Amneal Pharmaceuticals, LLC
Conditions:
Parkinson Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief 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 mo...
Detailed Description
This research is being done because a new, longer-duration formulation of levodopa named IPX203 (brand name: Crexont®) has been recently approved by the FDA. The pivotal study on this drug demonstrate...
Eligibility Criteria
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
- \- 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.
Key Trial Info
Start Date :
July 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 15 2027
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT07138560
Start Date
July 24 2025
End Date
May 15 2027
Last Update
August 24 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cleveland Clinic
Cleveland, Ohio, United States, 44195