BridgeMD
New treatment option for Parkinson Disease
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 ER?
CREXONT ER is an investigational medicine, given as an once-daily, being studied as a potential treatment for parkinson disease.
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 purpose of this study is to evaluate the effect of IPX203 (Crexont®) - the newest extended-release levodopa formulation - on the duration and quality of good on time, using a wearable device to monitor symptoms. 'Good on time' refers to a period (minutes to hours) when a patient experiences optimal symptom control due to effective medication and has better overall functioning without troublesome dyskinesias.
- 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; maximum levodopa dosing per day is 1200 mg if using...
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's taking place
- 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 - 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?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.