BOOST-PD: Crexont (IPX203) to lengthen and improve 'good on' time in Parkinson's
BOOST-PD - Better On-time Observations of Motor Fluctuations Using Wearable Sensor Technology: A Naturalistic Study on IPX-203 for Parkinson's Disease
This study will see if switching to IPX203 (Crexont), a longer‑acting levodopa formulation, can increase and improve periods of 'good on' time for people with Parkinson's who still have at least two hours of off time each day.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT07138560 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are people aged 40 or older with idiopathic, levodopa‑responsive Parkinson's, a baseline MDS‑UPDRS OFF score >20, at least two hours of off time per day, and a stable carbidopa‑levodopa regimen who can wear the KinesiaU device.
Not a fit: Patients with severe dyskinesia (UPDRS IV Q4 = 4), those on device‑aided advanced therapies, users of controlled‑release levodopa, or anyone not levodopa‑responsive or unable to comply with the wearable are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could increase daily good on‑time, reduce off‑time, and improve day‑to‑day functioning for people with Parkinson's.
How similar studies have performed: A prior pivotal trial showed IPX203 increased daily good on‑time versus immediate‑release carbidopa‑levodopa using patient diaries, but using a wrist wearable to objectively measure on‑time and applying tailored real‑world dose adjustments is a more novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cleveland, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.