The purpose of the study is to assess the efficacy and safety of XP21279/Carbidopa in comparison to Sinemet as well as evaluate the pharmacokinetics (PK) of levodopa after administration of XP21279/Carbidopa and Sinemet and to explore exposure-response relationships in a subset of subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
35
Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed XP21279 and Carbidopa
Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed Sinemet.
Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed placebo for XP21279 and carbidopa
XenoPort Clinical Site
Phoenix, Arizona, United States
XenoPort Clinical Site
Little Rock, Arkansas, United States
XenoPort Clinical Site
Long Beach, California, United States
Change from Baseline in mean daily "off" time at end of double-blind maintenance treatment periods.
Time frame: 2 weeks
Proportion of responders ("much improved" or "very much improved") on Investigator-rated and patient-rated CGI-I at end of double-blind Maintenance Treatment periods
Time frame: 2 weeks
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Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed placebo for Sinemet
XenoPort Clinical Site
Sunnyvale, California, United States
XenoPort Clinical Site
Naples, Florida, United States
XenoPort Clinical Site
Tampa, Florida, United States
XenoPort Clinical Site
Kansas City, Kansas, United States
XenoPort Clinical Site
Bingham Farms, Michigan, United States
XenoPort Clinical Site
West Bloomfield, Michigan, United States
XenoPort Clinical Site
New Brunswick, New Jersey, United States
...and 2 more locations