Evaluation of Dalfampridine Extended Release 5 and 10 mg in Multiple Sclerosis

Abstract

Background: Dalfampridine extended-release (ER) tablets, 10 mg twice daily, have been shown to improve walking in people with multiple sclerosis. We evaluated the safety and efficacy of dalfampridine-ER 5 mg compared with 10 mg.

Assessment of confirmed urinary tract infection in patients treated with dalfampridine for multiple sclerosis

“…Because of the clinical implications of UTIs in people with MS, an objective of this study was to examine the increased risk of confirmed UTI as part of a postmarketing commitment. measures and the overall tolerability have previously been described [15]. Briefly, the study included a 1-week screening and 4-week treatment period (visit 1: randomization and baseline safety and efficacy assessments; visit 2: week-2 interim assessments; and visit 3: week-4 assessments and study completion).…”

Effects of Dalfampridine Extended-release Tablets on 6-minute Walk Distance in Patients With Multiple Sclerosis: A Post Hoc Analysis of a Double-blind, Placebo-controlled Trial

“…A detailed description of the patient selection and methodology in this study has been previously published. 6 In brief, in this randomized, double-blind, placebo-controlled, parallel-group study, after a 1-week screening period, participants were randomly assigned, in a 1:1:1 ratio, to receive dalfampridine ER 5 or 10 mg or placebo, BID for 4 weeks. The study was performed in accordance with the revised Declaration of Helsinki.…”

“…4 Dalfampridine ER is a broad-spectrum inhibitor of voltage-gated potassium channels, with a putative mechanism of action of improving actionpotential conduction in the demyelinated axons that are characteristic of MS. 5 To fulfill a postmarketing regulatory commitment, a study was performed to evaluate the efficacy and safety profile of dalfampridine ER 5 mg BID, relative to the approved dose of 10 mg BID, to those of placebo was performed. 6 The primary efficacy end point of the original study, change from baseline on the timed 25-foot walk (T25FW) test at 4 weeks after the start of treatment, was not significantly different between either of the active treatment groups and the placebo group. However, in a post hoc analysis of mean data from all study visits, walking speed was significantly increased in the 10-mg BID dose group compared with that in the placebo group (nominal P ¼ 0.014).…”

“…However, in a post hoc analysis of mean data from all study visits, walking speed was significantly increased in the 10-mg BID dose group compared with that in the placebo group (nominal P ¼ 0.014). 6 Additionally, in a subgroup analysis, the change from baseline in walking distance, as assessed using the 6-minute walk (6MW) test, 7 was a prespecified secondary end point. A significant improvement in 6MW distance occurred in the 10-mg BID dose group, but not in the 5-mg BID dose group, versus the placebo group (nominal P values, 0.014 and 0.308, respectively).…”

Rehabilitation bei Multipler Sklerose: multimodal, interdisziplinär, wirksam

“…In einer nachfolgenden Dosisvergleichsstudie mit 2 × 5 mg versus 2 × 10 mg Fampridin über 4 Wochen war die über alle verfügbaren Messungen gemittelte Ganggeschwindigkeit nur mit 2 × 10 mg Fampridin gegenüber Placebo signifikant gesteigert. Allerdings scheint die Verbesserung der Ganggeschwindigkeit unter Fampridin nicht derjenigen eines Gangtrainings überlegen zu sein [27]. In weiteren Studien waren auch Aufstehen (Timed-Get-up-and-Go-Test), Gleichgewicht (Berg Balance Scale) und die MSWS-12 nach 6 Monaten Fampridin im Vergleich zu Placebo signifikant verbessert [6].…”