Research Study Summary
A Randomized, Multiple Dose Study to Assess the Pharmacokinetics and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease
- To compare the pharmacokinetics (PK) of single and multiple doses of IPX203 with Immediate release carbidopa-levodopa (IR CD-LD) in subjects with advanced Parkinson's disease (PD).
Clinical Trial Snapshot
- Both Male and Female
- 40 to 100 Years
- Overall Status
- IMPAX Laboratories, Inc.
- Facility Type
Eligibility will be determined at screening and Visit 1 of the study.
- Diagnosed with idiopathic PD at age = 40 years who are being chronically treated with stable regimens of CD-LD but experiencing motor complications.
- Hoehn and Yahr Stages 2, 3, or 4
- Montreal Cognitive Assessment (MoCA) score = 24 at Screening Visit in "on" state.
- For the 4 weeks prior to the Screening, the subject experiences daily "wearing-off" episodes with periods of bradykinesia and rigidity and experiences an "off" state upon awakening on most mornings by history.
- Responsive to CD-LD therapy and currently being treated on a stable regimen with CD-LD for at least 4 weeks prior to Visit 1
- Typically experiences an "on" response with the first dose of IR CD-LD of the day (by subject history).
- By history, efficacy of the first morning dose of IR CD-LD lasts less than 4 hours
- History of medical conditions or of a prior surgical procedure that would interfere with LD absorption, such as gastrectomy or proximal small-bowel resection.
- Liver enzyme values = 2.5 x the upper limit of normal; or history of severe hepatic impairment.
- History of drug or alcohol abuse within the 12 months prior to Screening.
- Received within 4 weeks of Visit 1 or planning to take during participation in the clinical study: any doses of a controlled-release (CR) LD apart from a single daily bedtime dose or any doses of Rytary, additional CD (eg, Lodosyn) or benserazide (eg, Serazide), or catechol-O-methyl transferase inhibitors (entacapone or tolcapone) or medications containing these inhibitors (Stalevo). Received within 4 weeks of Visit 1 or planning to take during participation in the clinical study: nonselective monoamine oxidase (MAO) inhibitors, apomorphine, or dopaminergic blocking agents including antiemetics.
- History of psychosis within the past 10 years.
- Treatment with any dopamine antagonist antipsychotics for the purposes of psychosis or bipolar disorder within the last 2 years.
- Based on clinical assessment, subject does not adequately comprehend the terminology needed to complete the PD Diary.
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