NCT00253084

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

A Randomized, Double-Blind, Cross-Over Study to Compare IPX054 to Carbidopa-Levodopa Immediate-Release Tablets in Subjects With Parkinson's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Impax Laboratories, LLC · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	IPX054 200 mg	IPX054 containing 50 mg carbidopa and 200 mg levodopa
DRUG	CD-LD IR	CD-LD IR containing 25 mg carbidopa and 100 mg levodopa
DRUG	IPX054 Placebo	Placebo to match IPX054 200 mg
DRUG	CD-LD IR Placebo	Placebo to match CD-LD IR

Timeline

• Start date: 2005-11-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2005-11-15
• Last updated: 2019-10-29

Locations

2 sites across 1 country: United States