Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's Disease

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective is to compare the pharmacokinetics and pharmacodynamics of IPX054 and carbidopa-levodopa immediate-release tablets in subjects with idiopathic Parkinson's disease who are currently being treated with a stable regimen of carbidopa-levodopa immediate-release tablets.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IMPAX Laboratories, Inc.; Impax Laboratories, LLC

Criteria

Inclusion Criteria:

• Clinical diagnosis of idiopathic Parkinson's disease

• Currently being treated with a stable dosage regimen of immediate-release carbidopa-levodopa for at least 3 months.

• Must experience at least 3 episodes of "wearing OFF" symptoms and an average of at least 2 hours of "OFF" time per day.

Exclusion Criteria:

• Diagnosed with atypical parkinsonism

• Prior surgical interventions for Parkinson's disease

• Glaucoma

• Undiagnosed skin lesion or history of melanoma

• Epilepsy or history of seizures