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

Impax Laboratories, LLC12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Parkinson's Disease

Interventions

IPX054 200 mgDRUG

IPX054 containing 50 mg carbidopa and 200 mg levodopa

CD-LD IRDRUG

CD-LD IR containing 25 mg carbidopa and 100 mg levodopa

IPX054 PlaceboDRUG

Placebo to match IPX054 200 mg

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

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.

Locations (2)

Site 1

Chicago, Illinois, United States

Site 2

Charleston, South Carolina, United States

Outcomes

Primary Outcomes

"ON" time without disabling dyskinesias

Time frame: 2 weeks

Secondary Outcomes

UPDRS analysis

Time frame: 2 weeks

Mean time to "ON"

Time frame: 2 weeks

Mean time to "wearing OFF"

Time frame: 2 weeks

Data from ClinicalTrials.gov

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