Clinical Trial TitleA randomized controlled study to compare the safety and efficacy of IPX203 with immediate-release carbidopa-levodopa in Parkinson’s disease patients with motor fluctuations. (Protocol No.: IPX203-B16-02)
National Clinical Trial Number:NCT03670953
Clinical Trial Protocol Description:
To evaluate the safety and efficacy of IPX203 in comparison to immediate-release carbidopa-levodopa (IR CD-LD) in the treatment of CD-LD-experienced subjects with Parkinson’s disease (PD) who have motor fluctuations. Nationwide, 510 participants will be enrolled for this study and Rush University Medical Center expects to enroll up to 5 participants. The treatment will be assigned randomly.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are male or female, diagnosed at age ≥ 40 years with Parkinson's diseae.
- Are currently treated with a stable regimen of CD-LD but experiencing motor fluctuations.
- Have a history, for the 4 weeks prior to trial screening, of experiencing daily “wearing-off” episodes with periods of bradykinesia in combination with at least one of rest tremor or rigidity, experiences an “Off” state upon awakening on most mornings, and reports an average of at least 2.5 cumulative hours per day of “Off” time during the waking hours.
- Are able to differentiate “On” state from “Off” state.
You will be excluded from the study if any of the following criteria apply to you:
- Have used any doses of controlled-release (CR) CD-LD apart from a single daily bedtime dose within 4 weeks prior to trial visit 1.
- Have used any dose of rytary for the past 4 weeks prior to trial visit 1 or were considered IPX066 or rytary failures for reasons of efficacy or safety.
- Had prior neurosurgical treatment for PD, or if such procedure is planned or anticipated during the study period.
This is a partial list of inclusion and exclusion criteria.
For more information about participation in the study please contact us by phone, (312) 563-2900, press 4; code name IPX203, or email, firstname.lastname@example.org.