Parkinson's Disease Clinical Trial
Official title:
Efficacy and Safety of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa Induced Dyskinesia in Parkinson's Disease Patients (EASE LID Study)
This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group
study to evaluate the efficacy and safety of ADS-5102 extended release (ER) capsules, an
investigational formulation of amantadine, dosed once nightly at bedtime 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) maximal concentrations in the
early morning through mid-day, when LID can be troublesome, and ii) lower concentrations in
the evening, potentially reducing the negative impact of amantadine on sleep. This
pharmacokinetic profile could enable higher doses to be tolerated with a once-nightly ER
formulation than can be tolerated with an immediate-release formulation. The once-nightly
dosing regimen may also provide enhanced convenience and compliance.
In a previous clinical study, ADS-5102 met its primary endpoint; LID was significantly
reduced as measured by the change in UDysRS score over 8 weeks vs. placebo.
n/a
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