NCT03007888

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Impax Laboratories, LLC · Industry
• Sex: All
• Age: 40 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed description

IPX203 is an investigational product containing CD-LD. IPX203-B16-01 Study Design: A randomized, open-label, rater-blinded, multicenter, 2-treatment, 2-period, multiple-dose crossover study. Approximately 30 qualified IR CD-LD-experienced advanced PD subjects will be randomized. The study duration will be approximately 8 weeks, including the screening period.

Conditions

• Advanced Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Sinemet	Immediate Release Tablet containing carbidopa-levodopa flexible dosing
DRUG	IPX203	Extended Release capsules containing carbidopa-levodopa flexible dosing

Timeline

• Start date: 2016-11-14
• Primary completion: 2017-08-01
• Completion: 2017-08-01
• First posted: 2017-01-02
• Last updated: 2022-06-06
• Results posted: 2022-06-06

Locations

11 sites across 1 country: United States