Comparison of IPX054 and Immediate-Release Carbidopa-Levodopa in Patients With Parkinson's Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Parkinson's Disease

In brief

The purpose of this study is to compare the clinical efficacy of IPX054 to immediate-release carbidopa-levodopa in subjects with Parkinson's disease.

Key facts

Study ID

NCT00253084

Run by

Impax Laboratories, LLC

People needed

12

Starts

2005-11-01

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 based on CAPIT (Core Assessment Program for Intracerebral Transplantations) criteria.
• Currently being treated with immediate-release carbidopa-levodopa with a stable dosing regimen over the past 4 weeks.

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 seizure.
• Requires concomitant therapy with tricyclic antidepressants, MAO-B inhibitors, COMT inhibitors or anticholinergics.
• Treatment with any neuroleptic agent, including atypical neuroleptics, within the previous 6 months.
• Treatment with any dopaminergic blocking agent within the previous 6 months.

Where it is running

• Site 1 — Chicago, Illinois, United States
• Site 2 — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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