Increase daily steady on time
- Trial ID
- NCT07138560
- Official Title
- BOOST-PD - Better On-time Observations of Motor Fluctuations Using Wearable Sensor Technology: A Naturalistic Study on IPX-203 for Parkinson's Disease
- Goal
- Increase daily steady on time
- Phase
- PHASE4
- Status
- RECRUITING
- Sponsor
- The Cleveland Clinic
- Study Type
- INTERVENTIONAL
- Enrollment
- 22 participants
- Conditions
- Parkinson Disease
- Interventions
- CREXONT ER
Plain-Language Summary
The goal is to find out whether CREXONT ER (IPX-203), an extended-release carbidopa‑levodopa, can give longer, steadier on time and reduce daily motor fluctuations for people with Parkinson's in their usual lives. CREXONT ER slowly releases levodopa to keep brain dopamine levels more stable than immediate-release pills, and the study uses a wearable motion sensor to track real-world on/off periods while people remain on compatible Parkinson's medications. The study is looking for adults 40 and older with idiopathic, levodopa-responsive Parkinson's who have at least 2 hours of off time per day and are on a stable carbidopa‑levodopa regimen; it excludes those with severe dyskinesia, device-based therapies, significant cognitive impairment, major levodopa complications, or current participation in other active drug trials.
Locations
- Cleveland Clinic, Cleveland, Ohio, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying CREXONT ER. The goal is to find out whether CREXONT ER (IPX-203), an extended-release carbidopa‑levodopa, can give longer, steadier on time and reduce daily motor fluctuations for people with Parkinson's in their usual lives. CREXONT ER slowly releases levodopa to keep brain dopamine levels more stable than immediate-release pills, and the study uses a wearable motion sensor to track real-world on/off periods while people remain on compatible Parkinson's medications. The study is looking for adults 40 and older with idiopathic, levodopa-responsive Parkinson's who have at least 2 hours of off time per day and are on a stable carbidopa‑levodopa regimen; it excludes those with severe dyskinesia, device-based therapies, significant cognitive impairment, major levodopa complications, or current participation in other active drug trials.
- Who can participate?
- Participants must be at least 40 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 4 trial is estimated to last approximately 10 months.