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
Summary For Families
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.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.