BOOST-PD: Crexont (IPX203) to lengthen and improve 'good on' time in Parkinson's

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

BOOST-PD is a phase 4 interventional study testing IPX203 (Crexont®), a recently FDA‑approved extended‑release levodopa, in a real‑world, tailored dosing setting. Participants who meet entry criteria will be converted to IPX203 and monitored with a wrist‑worn wearable (KinesiaU) to obtain objective measures of duration and quality of good on‑time. The study will compare changes in on‑time as measured by the wearable and will record tremor scores, medication conversions (for example from Rytary or COMT inhibitors), and changes in final IPX203 dose. The design aims to capture real‑world outcomes beyond prior diary‑based pivotal trials.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cleveland Clinic
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Hubert Fernandez, MD — The Cleveland Clinic
• Study coordinator: Saar Anis, MD
• Email: ANISS2@ccf.org
• Phone: 216 678-8896

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.