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A Randomized, Double-Blind, Cross-Over Study to Compare IPX054 to Carbidopa-Levodopa Immediate-Release Tablets in Subjects 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.
Age
30 - No limit years
Sex
ALL
Healthy Volunteers
No
Site 1
Chicago, Illinois, United States
Site 2
Charleston, South Carolina, United States
Start Date
November 1, 2005
Primary Completion Date
December 1, 2007
Completion Date
December 1, 2007
Last Updated
October 29, 2019
12
ACTUAL participants
IPX054 200 mg
DRUG
CD-LD IR
DRUG
IPX054 Placebo
DRUG
CD-LD IR Placebo
DRUG
Lead Sponsor
Impax Laboratories, LLC
NCT07310264
NCT02119611
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07216976