Evidence map›Paper›PMID 36746385›Full record

ArticleJournal of stroke2023

The Rescue on Reperfusion Damage in Cerebral Infarction by Nelonemdaz (RODIN) Trial: Protocol for a Double-Blinded Clinical Trial of Nelonemdaz in Patients with Hyperacute Ischemic Stroke and Endovascular Thrombectomy.

Jin Soo Lee, Ji Sung Lee, Byoung Joo Gwag, Dennis W Choi, Chun San An, Hyun Goo Kang, Tae-Jin Song, Seong Hwan Ahn, Chang Hun Kim, Dong-Ick Shin and 1 more

Registry-linked trialOpen access · diamondAbstract read
In one paragraph

Article in Journal of stroke, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05041010 (A Phase III, Double-blind, Randomized, Placebo-controlled, Multi-center Study to Assess the Efficacy and Safety of Nelonemdaz in Patients With Acute Ischemic Stroke), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
3.4field-weighted citation impact, top 7% 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.

NCT05041010 phase3unknown statusnot on this map

A Phase III, Double-blind, Randomized, Placebo-controlled, Multi-center Study to Assess the Efficacy and Safety of Nelonemdaz in Patients With Acute Ischemic Stroke

TypeinterventionalSponsorGNT PharmaRan2021 to 2025Enrolled496ConditionsIschemic StrokeArmsNeu2000KWL group, Placebo group
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 16 citations in OpenAlex.

  1. Trial
  2. Observational
  3. Review
  4. Article
  5. Review
  6. In search of real-world cerebroprotection: An institutional perspective and review of the literature.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2025
    Article
  7. Article
  8. Article
  9. Review
  10. Review
  11. Review
  12. Review
  13. Neuroprotective Strategies for Ischemic Stroke-Future Perspectives.International journal of molecular sciences · 2023
    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

11 authors at 7 institutions in 2 countries.

Jin Soo LeeDepartment of Neurology, Ajou University School of Medicine, Ajou University Medical Center, Suwon, Korea.
Ji Sung LeeClinical Research Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Byoung Joo GwagGNT Pharma Co., Ltd., Yongin, Korea.
Dennis W ChoiDepartment of Neurology, Stony Brook University School of Medicine, New York, NY, USA.
Chun San AnGNT Pharma Co., Ltd., Yongin, Korea.
Hyun Goo KangDepartment of Neurology and Research Institute of Clinical Medicine of Jeonbuk National University, Jeonju, Korea.
Tae-Jin SongDepartment of Neurology, Seoul Hospital, Ewha University College of Medicine, Seoul, Korea.
Seong Hwan AhnDepartment of Neurology, Chosun University College of Medicine, Gwangju, Korea.
Chang Hun KimDepartment of Neurology, Gyoungsang National University Hospital School of Medicine, Jinju, Korea.
Dong-Ick Shinpartment of Neurology, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea.
Sun U KwonDepartment of Neurology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Ulsan College · KRChosun University · KRChungbuk National University Hospital · KREwha Womans University · KRGyeongsang National University Hospital · KRJeonbuk National University · KRStony Brook University · US

Funding

GNT pharma
6 · The paper itself

Abstract

background and purposeNelonemdaz (Neu2000) has both selective antagonism against 2B subunit of N-methyl-D-aspartate receptor and antioxidant activity. This drug provides sufficient evidence of neuroprotection in acute cerebral ischemia/reperfusion models. This phase III trial aims to determine this effect in patients.

designThe Rescue on Reperfusion Damage in Cerebral Infarction by Nelonemdaz is a multicenter, double-blinded clinical trial. A total of 496 patients will be randomly assigned into the nelonemdaz (a total of 5,250 mg divided by 10 times for 5 days) and placebo groups. Patients will be included if they have an acute ischemic stroke (National Institutes of Health Stroke Scale score ≥8) caused by intracranial large vessel occlusion in the anterior circulation (Alberta Stroke Program Early CT Score ≥4), and if they are expected to undergo endovascular thrombectomy within 12 hours after stroke onset. ENDPOINTS: The primary endpoint is a favorable shift in the modified Rankin Scale (mRS) score at 90 days after the first dose of drug. The data will be analyzed by the Cochran-Mantel-Haenszel shift test. The secondary endpoints include functional independence (mRS 0-2) at 35 and 90 days, the favorable shift of mRS at 35 days, the proportion of mRS 0 at 35 and 90 days, and the occurrence rates of symptomatic intracranial hemorrhage within 7 days.

conclusionThis trial will clarify the efficacy and safety of nelonemdaz in patients with acute ischemic stroke and endovascular thrombectomy. This study has been registered at ClinicalTrials. gov (NCT05041010).

Indexed as

Cerebral infarctionClinical trialIschemic strokeNelonemdazProtocolsReperfusion injury

Identifiers

PMID36746385
PMCPMC9911845
OpenAlexW4318685191

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.