Dalfampridine to Improve Balance in Multiple Sclerosis: Substudy from a Randomized Placebo-Controlled Trial.

Dept. of Neurosciences, S. Camillo-Forlanini Hospital, C.ne Gianicolense 87, 00152, Rome, Italy. luca.prosperini@gmail.com. Istituto di Ricerca e Cura a Carattere Scientifico (IRCCS) Fondazione Don Carlo Gnocchi, -, Piazzale Morandi 6, 20121, Milano, Italy. Neurology Unit, S. Filippo Neri Hospital, Via G. Martinotti 20, 00135, Rome, Italy. S. Andrea Hospital, Sapienza University, Via di Grottarossa 1035, 00189, Rome, Italy. Dept. of Human Neuroscience, Sapienza University, Viale dell'Università 30, 00185, Rome, Italy. Dept. of Neurosciences, S. Camillo-Forlanini Hospital, C.ne Gianicolense 87, 00152, Rome, Italy.

Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics. 2020;(2):704-709

Abstract

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.

Methodological quality

Publication Type : Randomized Controlled Trial

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