CREXONT ER for Parkinson's (NCT07138560)
Increase daily good 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 good 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 study is testing Crexont, a newer, longer-acting form of levodopa, to see if it increases the amount and quality of "good on" time, meaning periods when symptoms are well controlled without troublesome involuntary movements, using a wrist-worn device to track symptoms. Participants will be switched to Crexont and have their dose adjusted in a real-world way while the KinesiaU wrist sensor measures on-time, tremor changes, and whether people move from other levodopa products like Rytary or from drugs called COMT inhibitors. This builds on earlier results showing Crexont increased daily good on-time compared with immediate-release levodopa, and now seeks objective, device-measured data after tailored dose adjustments. The study is looking for people aged 40 or older with Parkinson's who respond to levodopa, are on a stable levodopa schedule, have at least two hours of off time per day, and can wear the wrist sensor.
Locations
- Cleveland Clinic, Cleveland, Ohio, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying CREXONT ER. The study is testing Crexont, a newer, longer-acting form of levodopa, to see if it increases the amount and quality of "good on" time, meaning periods when symptoms are well controlled without troublesome involuntary movements, using a wrist-worn device to track symptoms. Participants will be switched to Crexont and have their dose adjusted in a real-world way while the KinesiaU wrist sensor measures on-time, tremor changes, and whether people move from other levodopa products like Rytary or from drugs called COMT inhibitors. This builds on earlier results showing Crexont increased daily good on-time compared with immediate-release levodopa, and now seeks objective, device-measured data after tailored dose adjustments. The study is looking for people aged 40 or older with Parkinson's who respond to levodopa, are on a stable levodopa schedule, have at least two hours of off time per day, and can wear the wrist sensor.
- 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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 4 trial is estimated to last approximately 1 year and 5 months.
- 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.
- 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.
- Will I get a placebo in this trial?
- Everyone in this trial receives the experimental treatment. There is no placebo group.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Wearable / at-home monitoring (non-invasive). Confirm the full schedule with the study coordinator.