This is a randomized, open-label, rater-blinded, multicenter, 3-treatment, 3 period, single-dose crossover study. Approximately 51 qualified immediate-release (IR) CD-LD-experienced advanced Parkinson's disease patients will be randomized to 1 of 3 dosing sequences. Objectives: * Assess the pharmacodynamics and pharmacokinetics (PK) of IPX203 (carbidopa and levodopa) in subjects with advanced Parkinson's disease. * Characterize the safety of IPX203 in subjects with advanced Parkinson's disease.
IPX203 contains two different drugs called levodopa and carbidopa in one capsule. * 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
26
CD-LD IR containing 25 mg carbidopa and 100 mg levodopa
IPX203 containing 45 mg carbidopa and180 mg levodopa
IPX203 containing 67.5 mg carbidopa and 270 mg levodopa
Muhammad Ali Movement Disorder Center (MAMDC)
Phoenix, Arizona, United States
Clinical Trials, Inc.
Little Rock, Arkansas, United States
The Parkinson's and Movement Disorder Institute
Fountain Valley, California, United States
"Off" time per the Assessment of Subject's Motor State
Time frame: Up to 10 hours
Duration of effect estimated using the timepoint at which an improvement of at least 4 points in the MDS-UPDRS Part III score from predose is first observed and continuing until the timepoint at which the improvement is no longer observed
Time frame: Up to 10 hours
Change from predose value in the number of finger-taps at each timepoint
Time frame: Up to 10 hours
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Rytary 48.75Mg-195Mg Extended-Release Capsule
Rytary 36.25Mg-145Mg Extended-Release Capsule
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States
Collier Neurologic Specialists
Naples, Florida, United States
University of South Florida Parkinson's Disease and Movement Disorder Center
Tampa, Florida, United States
Georgia Regents University
Augusta, Georgia, United States
QUEST Research Institute
Farmington Hills, Michigan, United States
Duke University Movement Disorders Clinic
Durham, North Carolina, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
...and 1 more locations