Safety and Efficacy of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment
Status:
Completed
Trial end date:
2016-06-01
Target enrollment:
Participant gender:
Summary
This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group
study of ADS-5102 extended release (ER) capsules, an investigational formulation of
amantadine, dosed once daily at bedtime for the treatment of walking impairment in MS.
ADS-5102 is designed to be administered once daily at bed time, ADS-5102 achieves higher
plasma amantadine concentrations in the early morning, sustained throughout the afternoon,
and lower concentrations in the evening when patients are sleeping. ADS-5102 is designed to
deliver its primary treatment effect during the day, and potentially reduce the adverse
events of immediate-release amantadine when the patient is asleep.