Dalfampridine to Improve Balance in Multiple Sclerosis: Substudy from a Randomized Placebo-Controlled Trial.
Luca ProsperiniLetizia CastelliLaura De GiglioValeria BonannoClaudio GasperiniCarlo PozzilliPublished in: Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics (2021)
This was a substudy of a randomized, double-blind, placebo-controlled trial originally designed to explore the effect of dalfampridine on information processing speed (2013-002558-64 EU Clinical Trials Register) in patients with multiple sclerosis (MS). A total of 120 patients were originally randomized in a 2:1 ratio to receive dalfampridine 10 mg or placebo twice daily for 12 weeks. Here, we sought to explore the effect of dalfampridine on static balance in single-task and dual-task conditions in a subgroup of 41 patients. They underwent static posturography in quiet standing (single-task) and while performing the Stroop test (dual-task) at randomization (baseline), after 12 weeks and after a 4-week wash-out period. Baseline characteristics of active group (n = 27) did not differ from those of placebo group (n = 14). Dalfampridine treatment was associated with better balance control than placebo in both single-task (F = 4.80, p = 0.034) and dual-task (F = 6.42, p = 0.015) conditions, with small-to-moderate effect sizes (Cohen's f2 = 0.122-0.162). The beneficial effect of dalfampridine was not retained 4 weeks after its discontinuation. The rate of accidental falls per month did not differ between the two groups (p = 0.12). Our preliminary findings suggest that dalfampridine can be considered a potential option to treat balance impairment due to MS. Larger sample sizes are needed to verify if the beneficial effect of dalfampridine on balance can be translated into a reduced risk of accidental falls.
Keyphrases
- double blind
- placebo controlled
- clinical trial
- multiple sclerosis
- phase iii
- end stage renal disease
- phase ii
- chronic kidney disease
- ejection fraction
- newly diagnosed
- prognostic factors
- ms ms
- open label
- peritoneal dialysis
- patient reported outcomes
- climate change
- randomized controlled trial
- white matter
- health information
- replacement therapy
- patient reported