Long-term effects of dalfampridine in patients with multiple sclerosis

Department of Neurology - University of Münster, Albert-Schweitzer-Campus 1, Building A 10, 48149 Münster, Germany.
Journal of the neurological sciences (Impact Factor: 2.47). 11/2013; 337(1-2). DOI: 10.1016/j.jns.2013.11.011
Source: PubMed


Dalfampridine is the extended-release formulation of 4-aminopyridine and is approved for the symptomatic treatment of impaired mobility in patients with multiple sclerosis. Our aim was to examine the short- and long-term effects of treatment with dalfampridine on motoric and cognitive assessment parameters of multiple sclerosis (MS) patients over 9-12months.
Fifty-two patients with MS with an EDSS between 4.0 and 7.0 and impaired mobility were evaluated for parameters of walking ability, MSFC, cognitive and motor fatigue and evoked potentials at treatment initiation with dalfampridine as well as 2weeks and after 9-12months later.
Thirty out of fifty-two patients (~60%) were still on treatment after 9-12months. Two weeks after treatment initiation, significant ameliorations could be found for T25FW, maximum walking distance as well as motoric and cognitive fatigue which still persisted after 9-12months. In contrast significant effects for velocity were observed only after 2weeks, for improvement in PASAT only after 9-12months. A tendency for improvement of somatosensory evoked potentials was found in a subset of patients.
Dalfampridine shows positive short- and long-term effects on motoric and cognitive assessment parameters in an open-label observational study in a cohort of patients with MS.

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    • "Prior to designing our study, little evidence existed to support the use of D-ER for improvement of dexterity. Since then, one study failed to find improvement on 9HPT after 2 weeks and after 9-12 months of treatment with D-ER [26]. Our study, however, supports other recent research [27] showing improvement in 9HPT performance and expands on these findings by also observing gross dexterity performance, lengthening the observation duration, and examining whether performance response varies based on traditional timed walk response. "
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    ABSTRACT: Dalfampridine extended release 10mg tablets (D-ER) have demonstrated improvement in walking for ambulatory persons with multiple sclerosis (pwMS), termed "responders." This study examined the extent additional aspects of gait and dexterity change for patients prescribed D-ER. Over 14-weeks, walking endurance, dynamic gait, self-report walking ability andfine and gross dexterity were examined in pwMS prescribed D-ER as a part of routine clinical care. The final results (n=39) validate that a subset of pwMS improve walking speed (Time 25-Foot Walk Test, p<0.0001). Significant improvements in gait and dexterity were observed even among participants who did not improve walking speed. Improvements were evident in gait and dexterity domains including Six Minute Walk Test, p=0.007, Six-Spot Step Test, p<0.0001, Multiple Sclerosis Walking Scale-12, p<0.0001, Nine Hole Peg Test, p<0.0001 dominant and non-dominant sides, and Box and Blocks Test, p=0.005 and 0.002, dominant and non-dominant sides, respectively. These findings suggest that D-ER may be a potential treatment for gait impairments, beyond walking speed and dexterity in pwMS. Further investigation regarding D-ER response is warranted. Copyright © 2015 Elsevier B.V. All rights reserved.
    Journal of the Neurological Sciences 06/2015; 356(1-2). DOI:10.1016/j.jns.2015.06.008 · 2.47 Impact Factor
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    ABSTRACT: We report a 14-week post-marketing experience on 20 patients with multiple sclerosis (MS) who started prolonged-release (PR) oral dalfampridine 10 mg twice daily according to European Medicine Agency criteria. They underwent serial static posturography assessments and the dizziness handicap inventory (DHI) to investigate whether PR dalfampridine could impact standing balance and self-reported perception of balance. The incidence of accidental falls per person per month was also recorded throughout the study. Eight (40%) patients, who had a relevant improvement in walking speed, were defined as treatment responders. They showed a significant improvement of standing balance (with respect to pretreatment assessment) when contrasted with 12 (60%) nonresponders (F [4,15] = 3.959, P = 0.027). No significant changes in DHI score, as well as in its functional, physical, and emotional subscales, were found in both responders and nonresponders at the end of study (all P values are ≥0.2). Treatment response did not affect the incidence of accidental falls. Future studies based on larger sample sizes, and with longer followup, are required to confirm the beneficial effect of PR dalfampridine on standing balance.
    03/2014; 2014(11):802307. DOI:10.1155/2014/802307
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    ABSTRACT: Walking impairment is a clinical hallmark of multiple sclerosis (MS). Dalfampridine-ER, an extended-release formulation of dalfampridine (also known by its chemical name, 4-aminopyridine, and its international nonproprietary name, fampridine), was developed to maintain drug plasma levels within a narrow therapeutic window, and assessed for its ability to improve walking in MS. The putative mechanism of action of dalfampridine-ER is restoration of axonal conduction via blockade of the potassium channels that become exposed during axonal demyelination. Two pivotal phase III clinical trials demonstrated that dalfampridine-ER 10-mg tablets administered twice daily improved walking speed and patient-reported perceptions of walking in some patients. Dalfampridine-ER was generally well tolerated, and, at the approved dose, risk of seizure was neither elevated relative to placebo nor higher than the rate in the MS population. Dalfampridine-ER (AMPYRA®) was approved in the United States for the treatment of walking in patients with MS as demonstrated by an increase in walking speed. The use of the dalfampridine-ER is contraindicated in patients with a history of seizure. It is the first pharmacologic therapy for this indication and has been incorporated into clinical management of MS.
    Annals of the New York Academy of Sciences 08/2014; 1329(1). DOI:10.1111/nyas.12512 · 4.38 Impact Factor
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