Clinical Trial Details

Overview

Research Study Summary

A Randomized, Multiple Dose Study to Assess the Pharmacokinetics and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease

Purpose
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:

Clinical Trial Snapshot

Phase
2
Gender
Both Male and Female
Age
40 to 100 Years
Overall Status
Recruiting
Lead Sponsor
IMPAX Laboratories, Inc.
Facility Type
N/A

Eligibility

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.

Contact

Leigh Donharl
University of South Florida - USF Health Byrd Alzheimer's Institute
4001 E. Fletcher Ave
Tampa, FL 33613
Phone: (813) 396-0763

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