Status:
COMPLETED
Comparison of IPX054, IR Carbidopa-Levodopa, and CR Carbidopa-Levodopa in Subjects With Parkinson's Disease
Lead Sponsor:
Impax Laboratories, LLC
Conditions:
Idiopathic Parkinson's Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE2
Brief Summary
The objective of this study is to compare the pharmacokinetics and pharmacodynamics of IPX054, carbidopa-levodopa immediate-release tablets, and carbidopa-levodopa controlled-release tablets in subjec...
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.
- Currently being treated with immediate-release or controlled-release carbidopa-levodopa and not requiring more than 200 mg levodopa per dose.
- Must experience "wearing OFF" between doses of medication.
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 seizures.
- Treatment with any neuroleptic agent, including atypical neuroleptics, within the previous 12 months.
- Treatment with any dopaminergic blocking agent within the previous 3 months.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00279825
Start Date
January 1 2006
End Date
December 1 2007
Last Update
October 29 2019
Active Locations (2)
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1
Quest Research Institute
Bingham Farms, Michigan, United States, 48025
2
Oregon Health Sciences University - Parkinson's Center of Oregon
Portland, Oregon, United States, 97239