NCT07138560

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

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 demonstrated that IPX203 significantly increased the daily good on-time compared to immediate release carbidopa-levodopa (IR CD-LD), where good on-time is the time when the Parkinson's symptoms are improved without troublesome dyskinesias. In that study, the participants were taking IPX203 a mean of 3 times per day which still left a mean of 4.18 hours of off-time per day (when symptoms returned). These data were based on diaries filled out by the participants. The aim of the study is to expand the current knowledge on IPX203, analyzing the changes in good on-time after careful and tailored adjustments, as in the real-world setting. This will be done with the assistance of a wearable device to obtain objective data. Additional variables such as changes in the tremor scores, conversion from other drugs such as Rytary and COMT inhibitors, and the difference between starting and final IPX203 doses will be evaluated.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	CREXONT ER	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

Timeline

• Start date: 2025-07-24
• Primary completion: 2026-05-15
• Completion: 2027-05-15
• First posted: 2025-08-24
• Last updated: 2025-08-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study