From the MS Center Sant'Andrea Hospital (L.D.G., F.G., G.B., C.P.), Department of Human Neuroscience (L.D.G., F.D.L., F.G., I.F., C.P.), and Department of Psychology (F.D.L.), Sapienza University of Rome; Department of Neuroscience San Camillo-Forlanini Hospital (L.P., E.Q., C.G.); and Neurological Center of Latium (G.B.), IRCCS Neuromed, Rome, Italy.
Neurology. 2019 Aug 20;93(8):e733-e746. doi: 10.1212/WNL.0000000000007970. Epub 2019 Jul 22.
To test a possible benefit of dalfampridine on information processing speed (IPS), a key function for cognitive impairment (CogIm) in multiple sclerosis (MS).
In this randomized, double-blind, placebo-controlled trial, we included patients with a score on the Symbol Digit Modalities Test (SDMT) under the 10th percentile of the reference value. Patients were randomized in a 2:1 ratio to receive dalfampridine 10 mg or placebo twice daily for 12 weeks. They underwent a comprehensive neuropsychological evaluation at screening (T0), at the end of treatment (T1), and after a 4-week follow-up (T2). The primary endpoint was improvement in SDMT.
Out of 208 patients screened, 120 were randomized to receive either dalfampridine (n = 80) or placebo (n = 40). At T1, the dalfampridine group presented an increase of SDMT scores vs placebo group (mean change 9.9 [95% confidence interval (CI) 8.5-11.4] vs 5.2 [95% CI 2.8-7.6], = 0.0018; = 0.60 for raw score; and 0.8 [95% CI 0.6-1] vs 0.3 [95% CI 0.0-0.5], = 0.0013; = 0.61 for scores; by linear mixed model with robust standard error). The improvement was not sustained at T2. A beneficial effect of dalfampridine was observed in the Paced Auditory Serial Addition Test and in cognitive fatigue.
Dalfampridine could be considered as an effective treatment option for IPS impairment in MS.
2013-002558-64 EU Clinical Trials Register.
This study provides Class I evidence that for patients with MS with low scores on the SDMT, dalfampridine improves IPS.
测试地夫可特对多发性硬化症（MS）认知障碍（CogIm）患者信息处理速度（IPS）的可能益处。
在这项随机、双盲、安慰剂对照试验中，我们纳入了符号数字模态测验（SDMT）得分低于参考值第 10 百分位数的患者。患者以 2:1 的比例随机分为每日两次接受地夫可特 10mg 或安慰剂治疗 12 周。他们在筛选（T0）、治疗结束（T1）和 4 周随访（T2）时接受了全面的神经心理学评估。主要终点是 SDMT 的改善。
在 208 名筛选患者中，有 120 名被随机分为地夫可特组（n=80）或安慰剂组（n=40）。在 T1 时，地夫可特组的 SDMT 评分较安慰剂组升高（平均变化 9.9[95%置信区间（CI）8.5-11.4] vs 5.2[95%CI 2.8-7.6]，=0.0018；原始分数的 =0.60；9.0[95%CI 7.6-10.4] vs 5.4[95%CI 3.7-7.2]，=0.0025； 分数的 =0.61；线性混合模型稳健标准误差）。在 T2 时，这种改善并未持续。地夫可特在听觉连续加法测验和认知疲劳方面显示出有益的效果。
地夫可特可被视为治疗多发性硬化症患者 IPS 损伤的有效治疗选择。
2013-002558-64 EU 临床试验注册。
本研究提供了 I 级证据，表明对于 SDMT 得分较低的多发性硬化症患者，地夫可特可改善 IPS。
