Harsh John R, Hayduk Roza, Rosenberg Russell, Wesnes Keith A, Walsh James K, Arora Sanjay, Niebler Gwendolyn E, Roth Thomas
The University of Southern Mississippi, Hattiesburg, MS 39406, USA.
Curr Med Res Opin. 2006 Apr;22(4):761-74. doi: 10.1185/030079906X100050.
This study assessed the efficacy and safety of armodafinil, the longer half-life enantiomer of modafinil, for the treatment of excessive sleepiness in patients with narcolepsy.
This was a multicenter double-blind study with 196 patients (aged 18-65 years) randomized to receive armodafinil 150 mg (n = 65), armodafinil 250 mg (n = 67), or placebo (n = 64) once daily for 12 weeks.
Efficacy was assessed using the Maintenance of Wakefulness Test (MWT) (six 20-min subtests across the day), the Clinical Global Impression of Change (CGI-C), subjective measures of sleepiness (Epworth Sleepiness Scale), patient diaries, and evaluations of cognitive performance (Cognitive Drug Research) and fatigue (Brief Fatigue Inventory).
Armodafinil significantly increased MWT mean sleep latency (at 0900-1500) compared with placebo. The mean change from baseline at final visit for armodafinil was an increase of 1.3, 2.6, and 1.9 min in the 150-mg, 250-mg, and combined groups, respectively, compared with a decrease of 1.9 min for placebo (p < 0.01 for all three comparisons). Mean late-day MWT latency (1500-1900) was also significantly improved (difference of armodafinil combined group relative to placebo at final visit: 2.8 min, p = 0.0358). The proportions of patients who showed at least minimal improvement in the CGIC rating from baseline to final visit in the armodafinil 150-mg, 250-mg, and combined groups were 69%, 73%, and 71%, respectively, compared with 33% for placebo (p < 0.0001). Both doses were associated with statistically significant improvements in memory, attention, and fatigue (p < 0.05). The most common adverse events in patients receiving armodafinil were headache, nausea, and dizziness.
Armodafinil significantly improved ability to sustain wakefulness throughout the day in patients with narcolepsy. Armodafinil also significantly improved overall clinical condition, memory, attention, and fatigue when compared with placebo.
本研究评估了莫达非尼的半衰期更长的对映体阿莫达非尼治疗发作性睡病患者过度嗜睡的疗效和安全性。
这是一项多中心双盲研究，196例年龄在18至65岁之间的患者被随机分为三组，分别每日一次接受150毫克阿莫达非尼（n = 65）、250毫克阿莫达非尼（n = 67）或安慰剂（n = 64）治疗，为期12周。
使用清醒维持测试（MWT）（全天6个20分钟的子测试）、临床总体印象变化（CGI-C）、嗜睡主观测量指标（爱泼沃斯嗜睡量表）、患者日记以及认知表现评估（认知药物研究）和疲劳评估（简明疲劳量表）来评估疗效。
与安慰剂相比，阿莫达非尼显著增加了MWT的平均睡眠潜伏期（09:00 - 15:00）。在最后一次访视时，阿莫达非尼150毫克组、250毫克组和合并组相对于基线的平均变化分别增加了1.3分钟、2.6分钟和1.9分钟，而安慰剂组减少了1.9分钟（所有三项比较p < 0.01）。傍晚MWT潜伏期（15:00 - 19:00）也有显著改善（阿莫达非尼合并组在最后一次访视时相对于安慰剂的差异：2.8分钟，p = 0.0358）。在阿莫达非尼150毫克组、250毫克组和合并组中，从基线到最后一次访视CGIC评分至少有最小改善的患者比例分别为69%、73%和71%，而安慰剂组为33%（p < 0.0001）。两种剂量均与记忆、注意力和疲劳方面的统计学显著改善相关（p < 0.
