Parkinson Disease study: CREXONT ER
Official title BOOST-PD A Naturalistic Study on IPX-203 for Parkinson's Disease
ClinicalTrials.gov ID: NCT07138560
What this study is testing
What is Crexont?
an investigational extended-release levodopa drug being studied for Parkinson disease is designed to release levodopa slowly over time to provide longer periods of symptom control
Also referred to as IPX203.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out whether IPX203 changes how long and how well patients experience good on‑time, using a wrist‑worn device to track symptoms.
- Who it's for
- People who have Parkinson’s disease.
- What's involved
- Participants will take the study medication IPX203 and wear a small wrist device (KinesiaU) that records movement and symptom data.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- \- 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
You likely can't join if
- \- 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...
- History of dementia or MOCA score lower than 23
See the full eligibility 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...
- 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.
- \- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Cleveland, Ohio, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.