Comparison of IPX054 and Immediate-Release Carbidopa-Levodopa in Patients With Parkinson's Disease
Comparison of IPX054 and Immediate-Release Carbidopa-Levodopa in Patients With Parkinson's Disease
The purpose of this study is to compare the clinical efficacy of IPX054 to immediate-release
 carbidopa-levodopa in subjects with Parkinson's disease.
IPX054 contains two different drugs called levodopa and carbidopa in one tablet.

 -  levodopa turns into a material called 'dopamine' in your brain. The dopamine helps to
 improve the symptoms of your Parkinson's disease.

 -  carbidopa belongs to a group of medicines called 'aromatic amino acid decarboxylase
 inhibitors'. It helps levodopa work more effectively by slowing the speed at which
 levodopa is broken down in your body.
Inclusion Criteria:

 -  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.

 Exclusion Criteria:

 -  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.