BOOST-PD Study of IPX-203 for Parkinson's Disease

This study is looking at IPX-203 (Crexont®), a new extended-release levodopa medication for Parkinson's disease. Researchers want to see how this medication affects your "good on time" – the period when your Parkinson's symptoms are well-controlled without bothersome involuntary movements (dyskinesias). A wearable device on your wrist will help monitor these changes. You may be able to join if you are 40 or older, have Parkinson's that responds to levodopa, and are currently on a stable levodopa regimen. The main goal is to measure the change in your good on time over 8 weeks. The current recruitment status is unclear, and the study plans to enroll 22 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 22 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 8 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07138560

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

Recruiting
PHASE4Ages 40+InterventionalTreatment
The Cleveland Clinic
~22 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:CREXONT ER

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Endpoint
Measured over 8 weeks
Parkinson Disease

NCT07138560

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cleveland Clinic

    Cleveland, Ohiono site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Hubert Fernandez, MD · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic

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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.
  • Primary Endpoint8 weeks

    Mean change in the average duration of good on-time from baseline to end of study