Sleep medicine · 2025
A phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial of lemborexant in adults with insomnia disorder.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеКлиническое исследование III фазыПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Mi Wei-Feng, Wen Dan, Xu Lijun, Pan Jiyang, Gu Ping, Wang Changhong, Tang Jiyou, Zhang Li, Liu Chun-Feng, Yuan Chengmei, Wang Hanqiao, Yamakawa Naoto, Takase Takao, Moline Margaret, Lu Lin
Аннотация
INTRODUCTION: This study evaluated the efficacy and safety of lemborexant (LEM), a dual orexin-receptor antagonist, in participants with insomnia disorder in China.
METHODS: E2006-J086-311 (Study 311; NCT04549168), a 1-month, multicenter, randomized, double-blind, placebo (PBO)-controlled, parallel-group study, enrolled adults (≥18 years) with insomnia disorder in China. Pairs of polysomnograms were conducted during a 7-day PBO run-in period (baseline), after the first 2 doses of LEM 10 mg (LEM10) or PBO, and after the last 2 doses at the end of 1 month of treatment. Objective sleep parameter assessments included latency to persistent sleep (LPS; primary endpoint) and secondary endpoints of sleep efficiency, wake after sleep onset (WASO), and total sleep time (TST; exploratory endpoint). Safety data were collected.
RESULTS: Among 194 participants randomized (PBO, n = 100; LEM10, n = 94), the median age was approximately 42 years; most participants were female (PBO: 74.0 %; LEM10: 61.3 %). Following 1 month of treatment, mean (standard deviation [SD]) decreases from baseline in LPS were larger (improved) for the LEM10 treatment group (-39.47 min [46.147 min]) versus PBO (-21.71 min [42.809 min]; post hoc Box-Cox transformation, p = 0.0096). LEM10 demonstrated larger and statistically significant increases from baseline (improvements) in sleep efficiency (p < 0.0001) and TST (p < 0.0001) and significant decreases from baseline (improvement) in WASO (p = 0.0002) versus PBO and was well-tolerated. No new safety signals with LEM were observed in the current study compared with the known safety profile.
CONCLUSIONS: LEM may be an important potential treatment option for patients with insomnia in China.
TRIAL REGISTRATION: ClinicalTrials.gov identifier (first submitted on 09-09-2020): NCT04549168; Study protocol and statistical analysis plan may be accessed at: https://clinicaltrials.gov/study/NCT04549168.
METHODS: E2006-J086-311 (Study 311; NCT04549168), a 1-month, multicenter, randomized, double-blind, placebo (PBO)-controlled, parallel-group study, enrolled adults (≥18 years) with insomnia disorder in China. Pairs of polysomnograms were conducted during a 7-day PBO run-in period (baseline), after the first 2 doses of LEM 10 mg (LEM10) or PBO, and after the last 2 doses at the end of 1 month of treatment. Objective sleep parameter assessments included latency to persistent sleep (LPS; primary endpoint) and secondary endpoints of sleep efficiency, wake after sleep onset (WASO), and total sleep time (TST; exploratory endpoint). Safety data were collected.
RESULTS: Among 194 participants randomized (PBO, n = 100; LEM10, n = 94), the median age was approximately 42 years; most participants were female (PBO: 74.0 %; LEM10: 61.3 %). Following 1 month of treatment, mean (standard deviation [SD]) decreases from baseline in LPS were larger (improved) for the LEM10 treatment group (-39.47 min [46.147 min]) versus PBO (-21.71 min [42.809 min]; post hoc Box-Cox transformation, p = 0.0096). LEM10 demonstrated larger and statistically significant increases from baseline (improvements) in sleep efficiency (p < 0.0001) and TST (p < 0.0001) and significant decreases from baseline (improvement) in WASO (p = 0.0002) versus PBO and was well-tolerated. No new safety signals with LEM were observed in the current study compared with the known safety profile.
CONCLUSIONS: LEM may be an important potential treatment option for patients with insomnia in China.
TRIAL REGISTRATION: ClinicalTrials.gov identifier (first submitted on 09-09-2020): NCT04549168; Study protocol and statistical analysis plan may be accessed at: https://clinicaltrials.gov/study/NCT04549168.