BOOST-PD A Naturalistic Study on IPX-203 for Parkinson's Disease

Launched by THE CLEVELAND CLINIC · Aug 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new extended-release form of a Parkinson’s medication called IPX203 (brand name Crexont®). The main goal is to see if this medicine can help people with Parkinson’s have longer and better “good on time,” which means periods when their symptoms are well controlled, and they can move and function more easily without troublesome side effects like involuntary movements. To track this, participants will wear a special device on their wrist called KinesiaU that monitors their symptoms throughout the day.

People who might be eligible for this study are adults aged 40 or older who have been diagnosed with Parkinson’s disease and respond well to levodopa, a common Parkinson’s medication. They should be on a stable medication routine and experience at least two hours a day when their medication isn’t working well (“off time”). Participants should not have severe side effects from their current treatment or certain other medical issues. During the study, participants will wear the monitoring device and continue their treatment so researchers can see how well IPX203 works in real-life settings. This study is currently recruiting, so if you or a family member fit these criteria and are interested, you may want to talk to your doctor about joining.

Gender

ALL

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.