Yuichi Inoue1, Toshiyuki Tabata2, Naoji Tsukimori3. 1. Japan Somnology Center, Institute of Neuropsychiatry, 5-10-10 Yoyogi, Shibuya-ku, Tokyo, 151-0053, Japan; Department of Somnology, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan. Electronic address: inoue@somnology.com. 2. Research and Development Headquarters, Alfresa Pharma Corporation, 2-2-9 Koku-machi, Chuo-ku, Osaka, 540-8575, Japan. 3. Medical Affairs Headquarters, Alfresa Pharma Corporation, 2-2-9 Koku-machi, Chuo-ku, Osaka, 540-8575, Japan.
Abstract
BACKGROUND: Few treatments are available for patients with idiopathic hypersomnia (IH). Modafinil, an established treatment for narcolepsy, was tested for efficacy and safety in Japanese patients with IH without long sleep time. METHODS: This multicenter, randomized, double-blind, placebo-controlled, parallel-group comparison study was conducted at 20 institutions in Japan. Patients who met the diagnostic criteria of IH in the 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 was administered orally once daily (in the morning). The primary efficacy endpoint was change in mean sleep latency on the Maintenance of Wakefulness Test (MWT). Adverse events (AEs) were also recorded to evaluate safety. RESULTS: In total, 123 patients were screened and 71 were randomized to receive modafinil (N = 34) or placebo (N = 37). Patients treated with modafinil experienced a significantly prolonged mean sleep latency on the MWT at the end of the study compared with placebo (5.02 min, 95% confidence interval: 3.26-6.77 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 = 6), dry mouth (n = 3), and nausea (n = 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.
RCT Entities:
BACKGROUND: Few treatments are available for patients with idiopathic hypersomnia (IH). Modafinil, an established treatment for narcolepsy, was tested for efficacy and safety in Japanese patients with IH without long sleep time. METHODS: This multicenter, randomized, double-blind, placebo-controlled, parallel-group comparison study was conducted at 20 institutions in Japan. Patients who met the diagnostic criteria of IH in the 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 was administered orally once daily (in the morning). The primary efficacy endpoint was change in mean sleep latency on the Maintenance of Wakefulness Test (MWT). Adverse events (AEs) were also recorded to evaluate safety. RESULTS: In total, 123 patients were screened and 71 were randomized to receive modafinil (N = 34) or placebo (N = 37). Patients treated with modafinil experienced a significantly prolonged mean sleep latency on the MWT at the end of the study compared with placebo (5.02 min, 95% confidence interval: 3.26-6.77 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 = 6), dry mouth (n = 3), and nausea (n = 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.
Keywords:
Idiopathic hypersomnia without long sleep time; Japanese version of the Epworth Sleepiness Scale; Maintenance of Wakefulness Test; Modafinil; Randomized controlled trial