Comparison of IPX054, IR Carbidopa-Levodopa, and CR Carbidopa-Levodopa in Subjects With Parkinson's Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Idiopathic Parkinson's Disease

In brief

The objective of this study is to compare the pharmacokinetics and pharmacodynamics of IPX054, carbidopa-levodopa immediate-release tablets, and carbidopa-levodopa controlled-release tablets in subjects with idiopathic Parkinson's disease.

Key facts

Study ID

NCT00279825

Run by

Impax Laboratories, LLC

People needed

16

Starts

2006-01-01

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…

• Diagnosed with idiopathic Parkinson's disease.
• Currently being treated with immediate-release or controlled-release carbidopa-levodopa and not requiring more than 200 mg levodopa per dose.
• Must experience "wearing OFF" between doses of medication.

You may not qualify if…

• Diagnosed with atypical parkinsonism.
• Allergic or non-responsive to previous carbidopa-levodopa therapy.
• Active or history of narrow-angle or wide-angle glaucoma.
• History of seizure or epilepsy, or is currently taking an anti-convulsant for treatment of seizures.
• Treatment with any neuroleptic agent, including atypical neuroleptics, within the previous 12 months.
• Treatment with any dopaminergic blocking agent within the previous 3 months.

Where it is running

• Quest Research Institute — Bingham Farms, Michigan, United States
• Oregon Health Sciences University - Parkinson's Center of Oregon — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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