Evidence map›Paper›PMID 37875349›Full record

Trial reportSleep2024

Efficacy and safety of Dimdazenil in adults with insomnia disorder: results from a multicenter, randomized, double-blind, placebo-controlled phase III trials.

Zhaoyang Huang, Shuqin Zhan, Chunyan Chen, Ruoxi Zhang, Yanling Zhou, Jingjing He, Zhaocun Lin, Cungang Bao, Shuangpeng Zhu, Jianjun Zhao and 3 more

Open access · hybridAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Sleep, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.8field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 10 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 2 institutions in 1 country.

Zhaoyang HuangNeurology Department, Xuanwu Hospital Capital Medical University, Beijing, China.
Shuqin ZhanNeurology Department, Xuanwu Hospital Capital Medical University, Beijing, China.
Chunyan ChenShanghai Research Institute, Zhejiang Jingxin Pharmaceutical Co., Ltd, Shanghai, China.
Ruoxi ZhangShanghai Research Institute, Zhejiang Jingxin Pharmaceutical Co., Ltd, Shanghai, China.
Yanling ZhouShanghai Research Institute, Zhejiang Jingxin Pharmaceutical Co., Ltd, Shanghai, China.
Jingjing HeShanghai Research Institute, Zhejiang Jingxin Pharmaceutical Co., Ltd, Shanghai, China.
Zhaocun LinShanghai Research Institute, Zhejiang Jingxin Pharmaceutical Co., Ltd, Shanghai, China.
Cungang BaoShanghai Research Institute, Zhejiang Jingxin Pharmaceutical Co., Ltd, Shanghai, China.
Shuangpeng ZhuResearch and Development Management Department, Zhejiang Jingxin Pharmaceutical Co., Ltd, Zhejiang, China.
Jianjun ZhaoShanghai Research Institute, Zhejiang Jingxin Pharmaceutical Co., Ltd, Shanghai, China.
Shengan ZhangShanghai Research Institute, Zhejiang Jingxin Pharmaceutical Co., Ltd, Shanghai, China.
Yu JiangShanghai Research Institute, Zhejiang Jingxin Pharmaceutical Co., Ltd, Shanghai, China.
Yuping WangNeurology Department, Xuanwu Hospital Capital Medical University, Beijing, China.
Zhejiang Medicine (China) · CNCapital Medical University · CN

Funding

Zhejiang Jingxin Pharmaceutical Co., Ltd.
6 · The paper itself

Abstract

STUDY

objectivesTo evaluate the efficacy and safety of Dimdazenil, a novel partial positive allosteric modulator for GABAA receptor in adults with insomnia disorder.

methodsThis 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.

resultsA 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.

conclusionsDimdazenil 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.

Indexed as

Sleep Initiation and Maintenance DisordersAdultDouble-Blind MethodHumansLipopolysaccharidesPolysomnographySleepTreatment OutcomeLipopolysaccharidesDimdazenilGABAA receptorsinsomnia disorderpartial positive allosteric modulatorpolysomnography

Identifiers

PMID37875349
PMCPMC10851846
OpenAlexW4387931334

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.