No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
22 (estimated)
Sponsor
The Cleveland Clinic · Other
Who this trial is looking for
This trial is looking for people aged 40 and older with Parkinson's disease who are currently treated with a stable medication regimen. Participants will use a wearable device to help measure their symptoms while taking IPX-203.
Are You a Good Fit for This Trial?
Must be takingCD-LD
You may be able to join if
I am 40 years or older.
I have been diagnosed with Parkinson's disease.
I respond to levodopa treatment.
I have a baseline MDS-UPDRS score greater than 20.
I have been on a stable medication regimen for at least four weeks.
I experience at least 2 hours of off time each day.
I can use a wearable device.
You may not be able to join if
I have severe dyskinesia.
I am currently using device-aided therapies for advanced Parkinson's disease.
I use controlled-release levodopa except for a single bedtime dose.
I use on-demand therapy unless I can stop it during the trial.
I have a diagnosis of dopamine dysregulation syndrome.
I have a history of dementia or a MOCA score below 23.
I have significant medical issues that could interfere with the trial.
I am enrolled in other clinical trials with active medications.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 troubleso…
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. The change in the duration and quality of on-time will be measured by a wearable device placed on your wrist called KinesiaU.
Trial Locations
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Status
Eligibility Criteria
Inclusion 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 fre…
Inclusion 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 using Rytary
* 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.
Exclusion Criteria:
* \- 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.
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