Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's Disease
Idiopathic Parkinson's Disease
About this trial
This is an interventional treatment trial for Idiopathic Parkinson's Disease focused on measuring IPX054, Parkinson disease, Levodopa
Eligibility Criteria
Inclusion Criteria: 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 Criteria: Diagnosed with atypical parkinsonism Prior surgical interventions for Parkinson's disease Glaucoma Undiagnosed skin lesion or history of melanoma Epilepsy or history of seizures
Sites / Locations
- Site 101
- Site 102
Arms of the Study
Arm 1
Experimental
Experimental: carbidopa and levodopa
Subjects receive IPX054 100 mg, IPX054 150 mg, IPX054 200 mg, IPX054 250 mg, or IPX054 300 mg to achieve optimum dosage and dosing frequency as directed by the Investigator for 5 weeks.