Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)
Status:
Completed
Trial end date:
2013-10-01
Target enrollment:
Participant gender:
Summary
This is a multi-center, randomized, double-blind, placebo-controlled, 4-arm parallel group
study to evaluate the tolerability and efficacy of each of three dose levels of ADS-5102 oral
capsules, an extended release formulation of amantadine, dosed once daily for the treatment
of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel
pharmacokinetic profile of ADS-5102 is expected to achieve i) higher amantadine plasma
concentrations during daytime hours when dyskinesia as well as motor and non-motor symptoms
of PD are most problematic, ii) low amantadine plasma concentrations overnight, which may
reduce the sleep disturbances and vivid dreams occasionally associated with amantadine, and
iii) a reduced initial rate of rise in plasma concentration, which is expected to improve
overall tolerability of amantadine.