Status:
COMPLETED
Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's Disease
Lead Sponsor:
Impax Laboratories, LLC
Conditions:
Idiopathic Parkinson's Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE1
PHASE2
Brief Summary
The objective is to compare the pharmacokinetics and pharmacodynamics of IPX054 and carbidopa-levodopa immediate-release tablets in subjects with idiopathic Parkinson's disease who are currently being...
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
- Clinical diagnosis of idiopathic Parkinson's disease
- Currently being treated with a stable dosage regimen of immediate-release carbidopa-levodopa for at least 3 months.
- Must experience at least 3 episodes of "wearing OFF" symptoms and an average of at least 2 hours of "OFF" time per day.
Exclusion
- Diagnosed with atypical parkinsonism
- Prior surgical interventions for Parkinson's disease
- Glaucoma
- Undiagnosed skin lesion or history of melanoma
- Epilepsy or history of seizures
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00239564
Start Date
October 1 2005
End Date
December 1 2007
Last Update
October 29 2019
Active Locations (2)
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1
Site 101
Sunnyvale, California, United States, 94089
2
Site 102
Lawrence, Kansas, United States, 66045