Efficacy and safety of Dimdazenil in adults with insomnia disorder: results from a multicenter, randomized, double-blind, placebo-controlled phase III trials
Author:
Huang Zhaoyang12, Zhan Shuqin12, Chen Chunyan3, Zhang Ruoxi3, Zhou Yanling3, He Jingjing3, Lin Zhaocun3, Bao Cungang3, Zhu Shuangpeng4, Zhao Jianjun3, Zhang Shengan3, Jiang Yu3, Wang Yuping12
Affiliation:
1. Neurology Department, Xuanwu Hospital Capital Medical University , Beijing , China 2. Beijing Key Laboratory of Neuromodulation, Capital Medical University , Beijing , China 3. Shanghai Research Institute, Zhejiang Jingxin Pharmaceutical Co., Ltd , Shanghai , China 4. Research and Development Management Department, Zhejiang Jingxin Pharmaceutical Co., Ltd , Zhejiang , China
Abstract
Abstract
Study Objectives
To evaluate the efficacy and safety of Dimdazenil, a novel partial positive allosteric modulator for GABAA receptor in adults with insomnia disorder.
Methods
This was a 2-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group phase III study of Dimdazenil. The primary efficacy outcome was total sleep time (TST) analyzed by polysomnography (PSG) on day 13/14. Latency to persistent sleep (LPS), sleep efficiency (SE), and wake after sleep onset (WASO) were analyzed in the same way by polysomnography (PSG). The other secondary outcomes including the average subjective sleep latency (sSL), subjective TST (sTST), subjective SE (sSE), subjective WASO (sWASO), and subjective number of awakenings (sNAW) were analyzed from sleep diary data, and the insomnia severity index (ISI) was also assessed. Treatment-emergent adverse events (TEAEs) were monitored throughout the study.
Results
A total of 546 participants with insomnia (age ≥18 years) were randomized (2:1), received treatment with an oral dose of Dimdazenil (2.5 mg) or placebo, and analyzed. Compared to baseline and placebo, Dimdazenil demonstrated significant improvements in PSG measures, increased TST (71.09, 31.68 minutes, respectively; both p < 0.001), increased SE (13.26%, 5.55%, respectively; both < 0.001), reduced WASO (49.67, 20.16 minutes, respectively; both p < 0.001), and reduced LPS (21.65 minutes, p < 0.001; 6.46 minutes, p = 0.023). Compared to placebo, Dimdazenil also improved key self-reported measures of sTST (18.33 minutes, p < 0.001), sWASO (14.60 minutes, p < 0.001), sSL (4.23 minutes, p < 0.001), sSE (2.97%, p < 0.001), and sNAW (0.29, p < 0.001). Participants treated with Dimdazenil reported a significant improvement in ISI. Dimdazenil was well tolerated. The majority of TEAEs were mild or moderate. There were no clinically relevant treatment-related serious AEs and no deaths.
Conclusions
Dimdazenil of 2.5 mg provided significant benefit on sleep maintenance and sleep onset in individuals with insomnia disorder versus placebo, with a favorable safety profile and was well tolerated.
Clinical Trial Information
A multicenter, randomized, double-blind phase III clinical study evaluating the efficacy and safety of EVT201 capsules compared to placebo in patients with insomnia disorders (http://www.chinadrugtrials.org), with the number of CTR20201068.
Funder
Zhejiang Jingxin Pharmaceutical Co., Ltd.
Publisher
Oxford University Press (OUP)
Subject
Physiology (medical),Neurology (clinical)
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