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Efficacy and Safety of Modafinil in Patients with Idiopathic Hypersomnia Without Long Sleep Time

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Efficacy and Safety of Modafinil in Patients with Idiopathic Hypersomnia Without Long Sleep Time Sleep Medicine 80 (2021) 315e321 Contents lists available at ScienceDirect Sleep Medicine journal homepage: www.elsevier.com/locate/sleep Original Article Efficacy and safety of modafinil in patients with idiopathic hypersomnia without long sleep time: a multicenter, randomized, double-blind, placebo-controlled, parallel-group comparison study Yuichi Inoue a, b, *, Toshiyuki Tabata c, Naoji Tsukimori d a Japan Somnology Center, Institute of Neuropsychiatry, 5-10-10 Yoyogi, Shibuya-ku, Tokyo, 151-0053, Japan b Department of Somnology, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan c Research and Development Headquarters, Alfresa Pharma Corporation, 2-2-9 Koku-machi, Chuo-ku, Osaka, 540-8575, Japan d Medical Affairs Headquarters, Alfresa Pharma Corporation, 2-2-9 Koku-machi, Chuo-ku, Osaka, 540-8575, Japan article info abstract Article history: Background: Few treatments are available for patients with idiopathic hypersomnia (IH). Modafinil, an Received 11 September 2020 established treatment for narcolepsy, was tested for efficacy and safety in Japanese patients with IH Received in revised form without long sleep time. 9 December 2020 Methods: This multicenter, randomized, double-blind, placebo-controlled, parallel-group comparison Accepted 14 January 2021 study was conducted at 20 institutions in Japan. Patients who met the diagnostic criteria of IH in the Available online 20 January 2021 International Classification of Sleep Disorders (second edition) were included. The study comprised a 17-day observation period and a 3-week treatment period during which modafinil (200 mg) or placebo Keywords: fi Modafinil was administered orally once daily (in the morning). The primary ef cacy endpoint was change in mean Idiopathic hypersomnia without long sleep sleep latency on the Maintenance of Wakefulness Test (MWT). Adverse events (AEs) were also recorded time to evaluate safety. Randomized controlled trial Results: In total, 123 patients were screened and 71 were randomized to receive modafinil (N ¼ 34) or Maintenance of Wakefulness Test placebo (N ¼ 37). Patients treated with modafinil experienced a significantly prolonged mean sleep Japanese version of the Epworth Sleepiness latency on the MWT at the end of the study compared with placebo (5.02 min, 95% confidence interval: Scale 3.26e6.77 min; p < 0.001). AEs occurred in 58.8% (20/34) and 27.0% (10/37) of patients in the modafinil and placebo groups, respectively. Frequent AEs in the modafinil group were headache (n ¼ 6), dry mouth (n ¼ 3), and nausea (n ¼ 3); no clinically significant AEs occurred. Conclusion: Modafinil was shown to be an effective and safe treatment for excessive daytime sleepiness in patients with IH without long sleep time. Clinical trial registration: JapicCTI; 142539. © 2021 Elsevier B.V. All rights reserved. 1. Introduction ICSD-3 unified IH into a single category, defining it as central hypersomnia without an increased propensity for rapid eye A syndrome characterized by excessive daytime sleepiness movement (REM) sleep and with no distinction of whether it is (EDS), prolonged sleep, and sleep drunkenness with the absence of accompanied by long sleep [4]. cataplexy was named idiopathic hypersomnia (IH) in 1976 [1]. The IH manifests as EDS, and typical IH is characterized by long sleep disease characteristics of IH were put forward in the first edition of and severe prolonged sleep inertia consisting of irritability, the International Classification of Sleep Disorders (ICSD; 1990) [2]. automatism, and confusion known as “sleep drunkenness” [4]. In In 2005, the ICSD-2 further classified IH into “IH with long sleep central hypersomnias, including IH, a remarkable reduction in time” and “IH without long sleep time” [3]. However, in 2014 the quality of life has been reported, owing to the psychosocial and environmental changes that occur along with the symptoms [5]. Detailed information about the prevalence of IH has not been ob- * Corresponding author. Department of Somnology, Tokyo Medical University, 6- tained, but it has been reported that the typical IH is 10 times less 7-1 Nishishinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan. Fax: þ81 3 3460-3033. frequent than narcolepsy [6]. E-mail address: [email protected] (Y. Inoue). https://doi.org/10.1016/j.sleep.2021.01.018 1389-9457/© 2021 Elsevier B.V. All rights reserved. Y. Inoue, T. Tabata and N. Tsukimori Sleep Medicine 80 (2021) 315e321 patients provided written informed consent prior to inclusion in Abbreviations the study. AEs Adverse events 2.1. Patients ANCOVA Analysis of covariance CGI-C Clinical Global Impression of Change Patients who were diagnosed as having IH (with or without fi CI Con dence interval long sleep time) according to the ICSD-2 [3], were aged 16e64 EDS Excessive daytime sleepiness years, had a Japanese version of the Epworth Sleepiness Scale ESS Epworth Sleepiness Scale (JESS) total score of 11 [17], had a total sleep time of 6hon FAS Full analysis set nocturnal polysomnography (NPSG) [18], had an average sleep fi ICSD International Classi cation of Sleep Disorders latency of <8 min and sleep onset REM periods of 1timeas IH Idiopathic hypersomnia measured using the Multiple Sleep Latency Test (MSLT) [19], were JESS Japanese version of the Epworth Sleepiness Scale eligible for the study. Patients were excluded if they had 2sleep LS Least squares onset REM periods on the MSLT, an apnea-hypopnea index >10/h MSLT Multiple Sleep Latency Test on the NPSG, Periodic Limb Movement Index of >15/h on the MWT Maintenance of Wakefulness Test NPSG; chronic sleep deprivation or significantly irregular NPSG Nocturnal polysomnography bedtime, including shift- or night-shift workers, and patients who REM Rapid eye movement had less than 12 days with a sleep duration of 6 h in the 14 days prior to patient enrollment (based on sleep diary records); concomitant mental disorders such as depression or schizo- phrenia; concomitant brain organic disorders or epilepsy, cere- So far, there has been no established treatment for IH; most brovascular complications, or a history of cerebrovascular patients have received off-label treatment with drugs approved for disorder; or had been previously treated with modafinil. narcolepsy [7]. Modafinil [8,9] is a selective dopamine reuptake inhibitor that primarily works by promoting the function of the dopamine transporter, and has been frequently used as an off-label 2.2. Study schedule treatment for IH [7]. In the United States, although the American Society of Sleep Medicine guidelines mentioned the effectiveness of Prior to initiating the 3-week treatment period, there was an modafinil for the treatment of IH [10], it has not been approved by observation period of 17 days which included the screening the United States Food and Drug Administration. In Europe, mod- period and recording of baseline characteristics. Patients were afinil was initially approved by the European Medicines Agency for randomly assigned to receive two tablets of either modafinil the treatment of IH, but the indication was removed in 2011 (100 mg per tablet, 200 mg total) or placebo, which were to be because there was a paucity of data from appropriately controlled taken orally once daily in the morning for 3 weeks. A 3-week clinical trials of modafinil for this use [11]. The studies demon- treatment period of once daily modafinil was chosen based on strating the efficacy of modafinil for IH, on which approval was two previous studies in patients with narcolepsy where 3 weeks based, were uncontrolled [12] or were reported retrospectively was the shortest time point that significant improvements in effi- [13]. After 2011, a randomized controlled trial of modafinil for the cacy measures were reported [15,16]. Confirmation of the masking treatment of IH was conducted with a relatively small number of (the placebo and modafinil tablets were made indistinguishable patients; the trial did not report superiority in the reduction of from one another) and assignment of placebo/modafinil were mean sleep latency on the Maintenance of Wakefulness Test performed by a third party (Bell Medical Solutions Co., Ltd., Tokyo, (MWT), the primary outcome measure, for modafinil versus pla- Japan). The permuted block randomization method was used for cebo [14]. This result showed that appropriately powered clinical drug assignment. trials, with a similar number of patients as trials evaluating mod- Assessments of sleep logs, JESS records, NPSG, MSLT, MWT, and afinil in patients with narcolepsy [15,16], are warranted to examine Clinical Global Impression of Change (CGI-C) scale [20] were per- the effectiveness and safety of modafinil treatment for patients formed according to the study schedule. Concomitant use of the with IH. following drugs was prohibited from 15 days before NPSG admin- Considering this, we conducted a multicenter, randomized, istration (during the observation period) or 7 days before the start double-blind, placebo-controlled, parallel-group comparison study of sleep diary recording, whichever occurred first: central nervous to evaluate the efficacy and safety of modafinil treatment in Japa- system stimulants (methylphenidate, pemoline, methamphet- nese patients with IH without long sleep time, using previous amine, caffeine), antipsychotics, antidepressants, antiepileptics, clinical trials on narcolepsy as a reference for trial design [15,16]. To anxiolytics, sedative-hypnotics, antihistamines, warfarin, vaso- our knowledge, this was the first clinical trial to evaluate modafinil pressors, monoamine oxidase
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