Comparison of IPX054, IR Carbidopa-Levodopa, and CR Carbidopa-Levodopa in Subjects With Parkinson's Disease
Idiopathic Parkinson's Disease
About this trial
This is an interventional treatment trial for Idiopathic Parkinson's Disease
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Sites / Locations
- Quest Research Institute
- Oregon Health Sciences University - Parkinson's Center of Oregon
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Other
Other
Other
Other
Sequence 1
Sequence 2
Sequence 3
Sequence 4
Subjects take 1 tablet of IPX054 200 mg, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Second treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Third treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR and 1 tablet of CD-LD CR Placebo. In Fourth treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR.
Subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Second treatment, subjects take 1 tablet of IPX054 200 mg, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Third treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR. In Fourth treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR and 1 tablet of CD-LD CR Placebo.
Subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR and 1 tablet of CD-LD CR Placebo. In Second treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR. In Third treatment, subjects take 1 tablet of IPX054 200 mg, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Fourth treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo.
Subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR. In Second treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR and 1 tablet of CD-LD CR Placebo. In Third treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Fourth treatment, subjects take 1 tablet of IPX054 200 mg, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo.