Evidence map›Paper›PMID 41871187›Full record

ArticleJournal of diabetes research2026

Long-Term Safety and Efficacy of Crisugabalin for Diabetic Peripheral Neuropathic Pain: A 52-Week, Multicenter, Single-Arm Trial.

Xiaohui Guo, Kailiang Wang, Tingting Zhang, Jianhua Ma, Yukun Li, Chengxia Jiang, Jie Liu, Yawei Zhang, Fang Bian, Fang Zhang and 18 more

Registry-linked trialAbstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of diabetes research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05890053 (A 52-week, Open Phase III Study Evaluating the Long-term Safety and Efficacy of HSK16149 Capsules in Chinese Patients With Peripheral Neuralgia), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

NCT05890053 phase3completednot on this map

A 52-week, Open Phase III Study Evaluating the Long-term Safety and Efficacy of HSK16149 Capsules in Chinese Patients With Peripheral Neuralgia

TypeinterventionalSponsorHaisco Pharmaceutical Group Co., Ltd.Ran2022 to 2023Enrolled301ConditionsPeripheral Neuropathic PainArmsHSK16149 40mg BID
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

28 authors.

Xiaohui GuoDepartment of Endocrinology, Peking University First Hospital, Beijing, China, pkufh.com.ORCID https://orcid.org/0000-0002-5588-0995
Kailiang WangDepartment of Endocrinology, Emergency General Hospital, Beijing, China.
Tingting ZhangDepartment of Endocrinology, Peking University First Hospital, Beijing, China, pkufh.com.
Jianhua MaDepartment of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu Province, China, njmu.edu.cn.
Yukun LiDepartment of Endocrinology, The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei Province, China, hebmu.edu.cn.
Chengxia JiangDepartment of Endocrinology, The Second People's Hospital of Yibin, Yibin, Sichuan Province, China.
Jie LiuDepartment of Endocrinology, The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, Henan Province, China, haust.edu.cn.
Yawei ZhangDepartment of Endocrinology, Pingxiang People's Hospital, Pingxiang, Jiangxi Province, China, pxsrmyy.cn.
Fang BianDepartment of Endocrinology, Cangzhou People's Hospital, Cangzhou, Hebei Province, China, czrmyy.com.
Fang ZhangDepartment of Endocrinology, Kaifeng Hospital of Traditional Chinese Medicine, Kaifeng, Henan Province, China, kfszyy.cn.
Weijuan LiuDepartment of Endocrinology, Chongqing University Three Gorges Hospital, Chongqing, China, cqu.edu.cn.
Xiaohong WuDepartment of Endocrinology, Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang Province, China, hospitalstar.com.ORCID https://orcid.org/0000-0001-5984-3342
Xulei TangDepartment of Endocrinology, The First Hospital of Lanzhou University, Lanzhou, Gansu Province, China, lzu.edu.cn.ORCID https://orcid.org/0000-0003-0921-450X
Yihua WangDepartment of Endocrinology, Nanyang First People's Hospital, Nanyang, Henan Province, China.
Tao NingDepartment of Endocrinology, Baotou Central Hospital, Baotou, Inner Mongolia Autonomous Region, China, btzxyy.com.
Shuguang PangDepartment of Endocrinology, Jinan Central Hospital Affiliated to Shandong University, Jinan, Shandong Province, China, sdu.edu.cn.ORCID https://orcid.org/0000-0002-9742-8219
Ya LiDepartment of Endocrinology, First Affiliated Hospital of Xi'an Medical College, Xi'an, Shaanxi Province, China.
Lijun WangDepartment of Endocrinology, Taizhou First People's Hospital, Taizhou, Zhejiang Province, China.
Jia SunDepartment of Endocrinology, Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong Province, China, zjyy.com.cn.ORCID https://orcid.org/0000-0001-9617-5865
Honglin HuDepartment of Endocrinology, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui Province, China, ahmu.edu.cn.
Hong MaoDepartment of Endocrinology, The Central Hospital of Wuhan, Wuhan, Hubei Province, China, zxhospital.com.
Tianrong PanDepartment of Endocrinology, The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui Province, China, ahmu.edu.cn.ORCID https://orcid.org/0000-0002-4293-4579
Yufeng LiDepartment of Endocrinology, Beijing Pinggu District Hospital, Beijing, China.
Xin SunDepartment of Neurology, The First Hospital of Jilin University, Changchun, Jilin Province, China, jlu.edu.cn.
Ping LiDepartment of Endocrinology, Yuncheng Central Hospital, Yuncheng, Shanxi Province, China, ycch.cn.
Fangqiong LiMedical Department, Haisco Pharmaceutical Group Co., Ltd., Chengdu, Sichuan Province, China.
Qin HuangMedical Department, Haisco Pharmaceutical Group Co., Ltd., Chengdu, Sichuan Province, China.
Yaming LiMedical Department, Haisco Pharmaceutical Group Co., Ltd., Chengdu, Sichuan Province, China.

Funding

Haisco Pharmaceutical Group Co., Ltd
6 · The paper itself

Abstract

introductionThe HSK16149-201/301 trial demonstrated short-term efficacy of the GABA analog crisugabalin for diabetic neuropathic pain.

methodsIn the current study, patients in both the crisugabalin and placebo control groups of the HSK16149-201/301 trial were invited to receive 80 mg/day crisugabalin for an additional 52 weeks. The primary end point was safety. The secondary end point was pain control as measured using the Short-Form McGill Pain Questionnaire (SF-MPQ). A total of 301 patients (mean age 59.7 years and males 58.1%) were enrolled.

resultsThe rate of treatment-related adverse events (TRAEs) was 38.9% (117/301). The most frequent TRAEs were dizziness (27.2%), somnolence (8.3%), and peripheral edema (3.0%). The rate of Grade 3 or higher TRAEs was 1.7%. TRAEs led to dose reduction in 41 patients (13.6%), treatment interruption and discontinuation each in three patients (1.0%). At week 52, the mean difference in SF-MPQ pain rating index (PRI) and visual analog scale pain score from baseline was -2.5 (95% CI -2.9 to -2.0; paired t-test p < 0.0001) and -23.4 (95% CI -25.6 to -21.2; paired t-test p < 0.0001), respectively. The proportion of patients with SF-MPQ PPI score ≤ 1 increased by 19.0% over baseline (p < 0.0001).

conclusionsIn summary, crisugabalin at 80 mg/day was well tolerated and demonstrated sustained analgesic activities.

trial registrationClinicalTrials.gov identifier: NCT05890053.

Indexed as

AnalgesicsDiabetic NeuropathiesNeuralgiaAdultAgedFemaleHumansMaleMiddle AgedPain MeasurementTreatment OutcomeAnalgesics

Identifiers

PMID41871187
PMCPMC13140441

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Registered trials

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.