Evidence map›Paper›PMID 39107097›Full record

Trial reportStroke and vascular neurology2025

Safety and efficacy of GD-11 in patients with ischaemic stroke: a multicentre, double-blind, randomised, placebo-controlled, phase 2 trial.

Runhua Zhang, Gaifen Liu, Xingquan Zhao, Yilong Wang, Zixiao Li, Guofang Chen, Bo Liu, Yun Ling, Yongjun Wang, Shuya Li

Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Stroke and vascular neurology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

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

1 citing paper in PubMed.

  1. Cytoprotection Concepts for Ischemic Stroke in the Recanalization Era.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026
    Review
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

10 authors.

Runhua ZhangDepartment of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.ORCID 0000-0003-4825-191X
Gaifen LiuDepartment of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Xingquan ZhaoDepartment of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.ORCID 0000-0001-8345-5147
Yilong WangChina National Clinical Research Center for Neurological Diseases, Beijing, China.ORCID 0000-0002-3267-0039
Zixiao LiDepartment of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.ORCID 0000-0002-4713-5418
Guofang ChenXuzhou Central Hospital, Xuzhou, Jiangsu, China.
Bo LiuInner Mongolia University of Science and Technology, Baotou, Inner Mongolia, China.
Yun LingNanshi Hospital of Nangyang, Nanyang, Henan, China.
Yongjun WangChina National Clinical Research Center for Neurological Diseases, Beijing, China shuyali85@163.com yongjunwang@ncrcnd.org.cn.ORCID 0000-0002-9976-2341
Shuya LiChina National Clinical Research Center for Neurological Diseases, Beijing, China shuyali85@163.com yongjunwang@ncrcnd.org.cn.ORCID 0000-0002-7263-0365

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGD-11, a novel brain cytoprotective drug, was designed to be actively taken up and transported across the blood-brain barrier via the glucose transporter. This study aimed to evaluate the safety and efficacy of GD-11 for improving the recovery of patients with acute ischaemic stroke (AIS).

methodsA double-blind, randomised, placebo-controlled, phase 2 trial was conducted at 15 clinical sites in China. Patients aged 18-80 years with AIS within 48 hours were randomly assigned (1:1:1) to receive 160 mg GD-11, 80 mg GD-11 and placebo, two times a day for 10 days. The primary endpoint was a modified Rankin Scale (mRS) score of 0-1 at 90 days after treatment. The safety outcome was any adverse events within 90 days.

resultsFrom 17 November 2022 to 22 March 2023, a total of 80 patients in the 160 mg GD-11 group, 79 patients in the 80 mg GD-11 group and 80 patients in the placebo group were included. The proportion of an mRS score of 0-1 at day 90 was 77.5% in the 160 mg GD-11 group, 72.2% in the 80 mg GD-11 group and 67.5% in the placebo group. Though no significant difference was found (p=0.3671), a numerically higher proportion was observed in the GD-11 group, especially in the 160 mg GD-11 group. The incidence of adverse events was similar across the three groups (p=0.1992).

conclusionGD-11 was safe and well-tolerated. A dosage of GD-11 160 mg two times a day was recommended for a large trial to investigate the efficacy.

Indexed as

Ischemic StrokeNeuroprotective AgentsAdolescentAdultAgedAged, 80 and overChinaDisability EvaluationDouble-Blind MethodFemaleFunctional StatusHumansMaleMiddle AgedRecovery of FunctionTime FactorsNeuroprotective AgentsClinical TrialIschemic Stroke

Identifiers

PMID39107097
PMCPMC12107471

What Socratic holds

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LicenceCC BY-NC
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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 Socratic graph.