Evidence map›Paper›PMID 39508107›Full record

Trial reportStroke2024

Anti-Inflammatory Thrombolytic JX10 (TMS-007) in Late Presentation of Acute Ischemic Stroke.

Kuniyasu Niizuma, Naoko Nishimura, Keiko Hasegawa, Takashi Moritoyo, Kohsuke Kudo, Josh Bell, Michael Wald, Yoshifumi Umeda, Kazuhiko Kuribayashi, Yasuo Toda and 2 more

Abstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase II
In one paragraph

Trial report in Stroke, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–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

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. 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

12 authors.

Kuniyasu Niizuma *Department of Neurosurgery (K.N., T.T.),Tohoku University Graduate School of Medicine, Sendai, Japan.ORCID 0000-0001-9282-6499
Naoko Nishimura *Department of Research and Development, TMS Co, Ltd, Fuchu, Japan (N.N., K. Hasegawa, K. Hasumi).
Keiko HasegawaDepartment of Research and Development, TMS Co, Ltd, Fuchu, Japan (N.N., K. Hasegawa, K. Hasumi).
Takashi MoritoyoClinical Research Promotion Center, The University of Tokyo Hospital, Japan (T.M.).ORCID 0009-0001-2086-5103
Kohsuke KudoDepartment of Diagnostic Imaging, Faculty of Medicine, Hokkaido University, Sapporo, Japan (K. Kudo).ORCID 0000-0001-5351-9242
Josh BellBiogen Inc, Cambridge, MA (J.B., M.W.).
Michael WaldBiogen Inc, Cambridge, MA (J.B., M.W.).ORCID 0000-0003-3349-7415
Yoshifumi UmedaPPD-SNBL, Kagoshima, Japan (Y.U.).
Kazuhiko KuribayashiBiogen Japan Ltd, Tokyo (K. Kuribayashi, Y.T.).ORCID 0000-0001-5253-8783
Yasuo TodaBiogen Japan Ltd, Tokyo (K. Kuribayashi, Y.T.).ORCID 0000-0002-8737-5256
Teiji TominagaDepartment of Neurosurgery (K.N., T.T.),Tohoku University Graduate School of Medicine, Sendai, Japan.ORCID 0000-0003-3411-2900
Keiji HasumiDepartment of Research and Development, TMS Co, Ltd, Fuchu, Japan (N.N., K. Hasegawa, K. Hasumi).ORCID 0000-0002-3340-7312

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundContemporary thrombolytics in acute ischemic stroke are limited to administration within 4.5 hours of last known normal. JX10 (formerly TMS-007), a

methodsIn this multicenter, randomized, double-blind, placebo-controlled, dose-escalation phase 2a study, JX10 or placebo was administered as a single intravenous infusion to Japanese patients with acute ischemic stroke who were unable to receive tissue-type plasminogen activator or thrombectomy within 12 hours of last known normal. Primary end point was incidence of symptomatic intracranial hemorrhage with a worsening National Institutes of Health Stroke Scale score of ≥4 points within 24 hours of drug administration (symptomatic intracranial hemorrhage incidence).

resultsNinety patients received either placebo (n=38; female 26.3%) or JX10 at 1, 3, or 6 mg/kg (n=6, 18, 28; female 0%, 33.3%, and 42.9%, respectively). Median age (range) and baseline median (range) National Institutes of Health Stroke Scale scores were respectively 76.5 (42-87) and 8 (6-21) for the combined JX10 cohort (JX10 Cohorts) and 75.0 (34-85) and 8 (6-22) for placebo. Median (range) dosing time since last known normal was 9.5 (5.0-12.1) and 10.0 (3.7-12.0) hours for JX10 Cohorts and placebo, respectively. Symptomatic intracranial hemorrhage incidence was 0% (0/52 [95% CI, 0.0-5.6]) for JX10 Cohorts versus 2.6% (1/38 [95% CI, 0.1-13.8]) for placebo (

conclusionsJX10 was well tolerated and may expand the acute ischemic stroke therapeutic window as a novel thrombolytic agent. REGISTRATION: URL: https://rctportal.niph.go.jp/en; Unique identifier: jRCT2080223786.

Indexed as

Fibrinolytic AgentsIschemic StrokeAdultAgedAged, 80 and overAnti-Inflammatory AgentsBrain IschemiaDouble-Blind MethodFemaleHumansIntracranial HemorrhagesMaleMiddle AgedTreatment OutcomeAnti-Inflammatory AgentsFibrinolytic Agentsfibrinolytic agentsinfusions, intravenousintracranial hemorrhagesischemic strokeStachybotrys

Identifiers

PMID39508107
PMCPMC11593998

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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 Socratic graph.