Status:
COMPLETED
Comparison of IPX054 and Immediate-Release Carbidopa-Levodopa in Patients With Parkinson's Disease
Lead Sponsor:
Impax Laboratories, LLC
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE2
Brief 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 P...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00253084
Start Date
November 1 2005
End Date
December 1 2007
Last Update
October 29 2019
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Site 1
Chicago, Illinois, United States, 60612
2
Site 2
Charleston, South Carolina, United States, 29425