Stankoff B, Waubant E, Confavreux C, Edan G, Debouverie M, Rumbach L, Moreau T, Pelletier J, Lubetzki C, Clanet M
Fédération de Neurologie, Hôpital de la Salpêtrière, AP-HP, Paris, France.
Neurology. 2005 Apr 12;64(7):1139-43. doi: 10.1212/01.WNL.0000158272.27070.6A.
To assess whether modafinil, a wakefulness-promoting agent, is useful for fatigue in patients with multiple sclerosis (MS).
Patients with MS with stable disability, and a baseline score of 45 or more on the Modified Fatigue Impact Scale (MFIS), were eligible for the 5-week randomized, double-blind, placebo-controlled, parallel group study. The initial daily dose of modafinil was 200 mg for 1 week. Depending on tolerance, the dose was increased by 100 mg every week up to 400 mg/day and remained unchanged between day 21 and day 35. The primary outcome variable was the change of MFIS score at day 35.
A total of 115 patients with MS were enrolled in the study and in the intention to treat analysis. The mean MFIS score at baseline was 63 +/- 9 in the placebo group and 63 +/- 10 in the modafinil group. MFIS scores improved between day 0 and day 35 in both placebo-treated and modafinil-treated groups, but no significant difference was detected between the two groups. There was no major safety concern.
There was no improvement of fatigue in patients with multiple sclerosis treated with modafinil vs placebo according to the Modified Fatigue Impact Scale.
评估促醒药物莫达非尼对多发性硬化症（MS）患者疲劳是否有效。
残疾状况稳定、改良疲劳影响量表（MFIS）基线评分45分及以上的MS患者符合这项为期5周的随机、双盲、安慰剂对照、平行组研究的条件。莫达非尼初始日剂量为200毫克，持续1周。根据耐受性，每周剂量增加100毫克，直至400毫克/天，并在第21天至第35天保持不变。主要结局变量是第35天MFIS评分的变化。
共有115例MS患者纳入研究并进行意向性分析。安慰剂组基线时MFIS平均评分为63±9，莫达非尼组为63±10。安慰剂治疗组和莫达非尼治疗组在第0天至第35天MFIS评分均有改善，但两组间未检测到显著差异。未发现重大安全问题。
根据改良疲劳影响量表，与安慰剂相比，莫达非尼治疗多发性硬化症患者的疲劳无改善。
