A Study to Assess the PK and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease

• Status: Completed
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IMPAX Laboratories, Inc.; Impax Laboratories, LLC
• Treatments: Carbidopa; Carbidopa, levodopa drug combination; Levodopa

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.