A Study to Assess the PK and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease
Condition: Advanced Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Sinemet; IPX203
Intervention description: Immediate Release Tablet containing carbidopa-levodopa flexible dosing; Extended Release capsules containing carbidopa-levodopa flexible dosing
Intervention MeSH terms: Carbidopa, levodopa drug combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 28.0
Sex: All
Minimum age: 40 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: IPX203 (carbidopa-levodopa) Extended-Release capsules

Summary:

      Primary Objective:

      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).

      Secondary Objectives:

      To compare the pharmacodynamics of single and multiple doses of IPX203 with IR CD-LD.

      To compare the efficacy of IPX203 with IR CD-LD following multiple doses.

      To evaluate the safety of IPX203.
    

Eligibility criteria:

        Eligibility will be determined at screening and Visit 1 of the study.

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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.