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

Completed · Phase 1/Phase 2

Conditions studied: Idiopathic Parkinson's Disease

In brief

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.

Key facts

Study ID

NCT00239564

Run by

Impax Laboratories, LLC

People needed

12

Starts

2005-10-01

Expected to finish

2007-12-01

Last updated by the study team

2019-10-29

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Diagnosed with atypical parkinsonism
• Prior surgical interventions for Parkinson's disease
• Glaucoma
• Undiagnosed skin lesion or history of melanoma
• Epilepsy or history of seizures

Where it is running

• Site 101 — Sunnyvale, California, United States
• Site 102 — Lawrence, Kansas, United States

Full record on ClinicalTrials.gov

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