NCT05041010: RODIN

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

Status unknown Phase 3 Last updated 23 September 2022

What this trial tests

Phase 3 trial testing Neu2000KWL group in Ischemic Stroke in 496 participants. Status unknown.

Timeline

25 December 2021

Primary endpoint
1 June 2024

1 January 2025

Quick facts

Lead sponsor	GNT Pharma
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	496
Start date	25 December 2021
Primary completion	1 June 2024
Estimated completion	1 January 2025
Sites	24 locations across South Korea

Drugs / interventions tested

• Neu2000KWL group — full drug profile →
• Placebo group

Conditions studied

• Ischemic Stroke — all drugs for Ischemic Stroke →

Sponsor

GNT Pharma — full company profile →

Who can join

19 and older, any sex, with Ischemic Stroke. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• mRS score evaluated at 12 week after the first dose of drug (Nelonemdaz or Placebo).
  Time frame: week12

Sponsor's own description

Efficacy and safety of Neu2000, a multi-target drug designed to prevent both NMDA receptor-mediated excitotoxicity and free radical toxicity, will be investigated in acute ischemic stroke patients receiving endovascular treatment to remove clot within 12 hours following stroke onset. Neu2000KWL will be administered before endovascular treatment.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Neuroprotective Strategies for Ischemic Stroke-Future Perspectives.
   Haupt M, Gerner ST, Bähr M, Doeppner TR. · · 2023 · cited 112× · PMID 36901765 · DOI 10.3390/ijms24054334
2. Iron promotes both ferroptosis and necroptosis in the early stage of reperfusion in ischemic stroke.
   Du B, Deng Z, Chen K, Yang Z, et al · · 2024 · cited 26× · PMID 39286656 · DOI 10.1016/j.gendis.2024.101262
3. Targeting NMDA Receptors at the Neurovascular Unit: Past and Future Treatments for Central Nervous System Diseases.
   Seillier C, Lesept F, Toutirais O, Potzeha F, et al · · 2022 · cited 26× · PMID 36142247 · DOI 10.3390/ijms231810336
4. 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.
   Lee JS, Lee JS, Gwag BJ, Choi DW, et al · · 2023 · cited 14× · PMID 36746385 · DOI 10.5853/jos.2022.02453
5. Nelonemdaz and Patients With Acute Ischemic Stroke and Mechanical Reperfusion: The RODIN Randomized Clinical Trial.
   Lee JS, Kang HG, Ahn SH, Song TJ, et al · · 2025 · cited 7× · PMID 39874036 · DOI 10.1001/jamanetworkopen.2024.56535
6. Ischemic stroke and intervention strategies based on the timeline of stroke progression: Review and prospects.
   Xu A, Zhang H, Zhang Y, Wu J, et al · · 2025 · cited 5× · PMID 41049732 · DOI 10.1016/j.apsb.2025.07.026
7. Rationale and methods of the Antioxidant and NMDA receptor blocker Weans Anoxic brain damage of KorEa OHCA patients (AWAKE) trial.
   Choi JH, Chun BJ, Yeom SR, Chung SP, et al · · 2022 · cited 4× · PMID 35871083 · DOI 10.1186/s13063-022-06452-0
8. A Review on Adjunctive Therapies for Endovascular Treatment in Acute Ischemic Stroke.
   Goyal M, Rinkel LA, Ospel JM. · · 2023 · cited 2× · PMID 38025256 · DOI 10.5797/jnet.ra.2023-0035