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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Oral capsules to be administered once daily at bedtime for 4 weeks
Oral capsules to be administered once daily at bedtime for 4 weeks
Unnamed facility
Phoenix, Arizona, United States
Unnamed facility
Aurora, Colorado, United States
Unnamed facility
Sarasota, Florida, United States
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Northbrook, Illinois, United States
Unnamed facility
Rochester, Minnesota, United States
Unnamed facility
Lincoln, Nebraska, United States
Unnamed facility
Albuquerque, New Mexico, United States
Unnamed facility
Patchogue, New York, United States
Unnamed facility
Raleigh, North Carolina, United States
...and 5 more locations
Safety of ADS-5102 assessed by adverse events, safety-related study drug discontinuations, vital signs, and safety laboratory test
Time frame: Up to 4 weeks
Timed 25 Foot Walk
Time frame: Up to 4 weeks
Timed Up and go
Time frame: Up to 4 weeks
2 Minute Walk Test
Time frame: Up to 4 weeks
MS Walking Scale-12
Time frame: Up to 4 weeks
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