rial Design
The Phase 2 study (CVT
-
301
-
002) was a multicenter, randomized, double blind, placebo
-
controlled,
single dose, cross
-
over design with three arms (placebo, 25mg and 50mg) and included an “open label”
oral Sinemet arm. The twenty four (24) patients treated i
n this study underwent serial evaluations of L
-
dopa plasma levels, motor response, and safety at each visit. The patients were administered the study
drug in the OFF state with the serial evaluations starting prior to dosing and continuing for up to 180
m
inutes post
-
dose. Motor function was measured using a tapping test, the Unified Parkinson’s Disease
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used small doses, appears to be intended to be used as a rescue drug kind of like apomorphine(?) injections? more gets to the brain since bypasses digestive system.
i imagine a lot of advanced pd'ers need something like this, i know i could use it just to give me more confidence to get out and about and not have to worry as much about wearing off since i'm not taking a longer acting agonist. i doubt anyone could afford it as a primary treatment.
http://civitastherapeutics.com/cms/s...3%200419_1.pdf