RecruitingPhase 4NCT07138560

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

Sponsor

The Cleveland Clinic

Enrollment

22 participants

Start Date

Jul 24, 2025

Study Type

INTERVENTIONAL

Conditions

Parkinson Disease

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.

Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is tracking how people with Parkinson's disease respond in the real world when switching to or starting IPX-203 (Rytary extended release), a longer-acting form of levodopa — the main medication used to treat Parkinson's. It is an observational study, meaning it follows patients as they receive their normal care rather than assigning them a specific treatment. **You may be eligible if...** - You are 40 years or older - You have been diagnosed with Parkinson's disease that responds to levodopa - You experience at least 2 hours per day of "off time" — periods when your medication is not working well and symptoms like tremor or stiffness return - You are currently on a stable levodopa regimen - Your Parkinson's motor symptoms are moderate to severe when medication wears off **You may NOT be eligible if...** - You are unable to use the wearable movement-tracking device required by the study - Your Parkinson's diagnosis is atypical or secondary - You are not suitable for levodopa therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCREXONT 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