Conditions: Dyskinesia Levodopa Induced Dyskinesia Parkinson's Disease
Keywords: Levodopa-induced dyskinesia Parkinsonism
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 83
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: Low dose ADS-5102 (amantadine extended release) arm 3: A mid-dose ADS-5102 (amantadine extended release) arm 4: High dose ADS-5102 (amantadine extended release)

Interventions: intervention 1: ADS-5102 (extended release amantadine HCl)
Intervention descriptions: intervention 1: Oral capsules to be administered once daily at bedtime, for 8 weeks

Protocol document: