A randomized placebo controlled double-blind cross-over trial of Dalfampridine ER for effect on ambulatory activity in people with multiple sclerosis
This is a parallel-group, double-blind, randomized controlled crossover trial with a 1:1 randomization. There are two treatment periods of 4 weeks and a two-week off treatment washout period. Treatment periods are DER (dalfampridine ER) followed by placebo (group A) and placebo followed by DER (group B), respectively. All dosages will be administered twice a week. Purpose of the study is to see if using the study drug(dalfampridine Er) for a short period of time will improve the way subjects with multiple sclerosis (MS) walk.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
43
dalfampridine ER 10mg bid for 4 weeks
identical placebo tablet administered bid for four weeks
MS Center at Evergreen
Kirkland, Washington, United States
Peak Activity Index
peak activity index is a measure of the 30 fastest minutes of walking over a 24 hour period, averaged over one week of accelerometer wear. Measurement is change from baseline to 4 weeks on intervention
Time frame: 10 weeks
Stepcount
change in daily stepcount recorded by an accelerometer and averaged over 1 week of wear baseline vs 4 weeks
Time frame: 10 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.