BOOST-PD A Naturalistic Study on IPX-203 for Parkinson's Disease
Recruiting
Phase 4
Interventional Study
Parkinson Disease
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.
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
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About This Trial
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…
Trial Locations
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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…
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