Ischemic StrokePhase 3RODINNCT05041010
Rescues On Reperfusion Damage In Cerebral Infarction by Nelonemdaz
A Phase 3 study testing Neu2000KWL group in people with Ischemic Stroke, run by GNT Pharma at 24 sites in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Neu2000KWL group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 496 participants
- Where
- 24 sitesSouth Korea
- Study dates
- 25 Dec 2021to Jan 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The trial subjects should satisfy all the following criteria.
- Adults≥19 years
- Patients who can start endovascular therapy within 12 hours after the symptomatic onset of Ischemic stroke.
- NIHSS on screening time point ≥ 8 points
- Patients whose general condition was favorable enough to perform daily activities without the help of others one day prior to the ischemic stroke onset (a person with mRS 0 or 1)
- Patients whose CTA or MRA confirmed internal carotid artery occlusion and M1 or M2 occlusion of the middle cerebral artery, that are the types of major cerebral artery occlusion that can cause acute cerebral infarction and are subject to endovascular therapy.
- Patients with early ASPECTS point≥4 (Noncontrast brain cross-section CT or Brain cross-section MRI diffusion weighted imaging)
- Patients who spontaneously submitted a written informed consent to participation on this clinical study.
Who cannot join
- A patient who meets any one of the conditions below cannot participate in the Clinical trial.
- Patients who meet the following exclusion criteria on imaging of endovascular therapy
- ① Patients whose occlusion location that can cause an acute ischemic stroke in the CTA (CT angiography) image meets under the following conditions: A. Occlusion of bilateral large artery B. Simultaneous infiltration of anterior and posterior circulation
- Patients who have contraindication to contrast media for brain imaging.
- Patients who are receiving renal replacement therapy such as dialysis due to acute or terminal nephropathy at screening point.
- Patients who were diagnosed with cancer or received cancer therapy within 6 months at screening or have recurrent or transitional cancer.
Show all 12Show fewer
- Patients have high body temperature of 38oC or more and need antibiotic therapy due to medical opinion of infectious disease at screening.
- Patients who are having pharmacotherapy due to liver diseases such as hepatic cirrhosis, etc. at screening point.
- Patients who are pregnant or lactating. However, only a woman who has no possibility of pregnancy can participate in this clinical research.
- Woman with child-bearing potential can be defined as the woman who has not had the clear menopause or who has not had surgical treatment that makes pregnancy impossible.
- Patients who have participated in other clinical trial within past 6 months at the screening time as a base. However, in case of participation of observatory experiment, the patient can participate in this clinical trial.
- Patients who are determined unsuitable for participation in this clinical trial due to other reasons
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
South Korea24 sites, 24 recruiting
- Recruiting
Inje University Busan Paik Hospital
Busan, 47392
Eung Gyu Kim
- Recruiting
Dong-A University Hospital
Busan, 49201
Jae Gwan Cha
- Recruiting
Gyeongsang National University Hospital
Changwon, 52727
Soo Kyoung Kim
- Recruiting
Chungbuk National University Hospital
Cheongju-si, 28644
Dong Ick Shin
- Recruiting
Kyungpook National University Hospital
Daegu, 41944
Yang Ha Hwang
- Recruiting
Keimyung University Dongsan Medical Center
Daegu, 42601
Sung Il Sohn
- Recruiting
Daejeon Eulji Medical Center, Eulji University
Daejeon, 35233
Jae Kook Kim
- Recruiting
Chosun University Hospital
Gwangju, 61453
Seong Hwan Ahn
- Recruiting
Chonnam National University Hospital
Gwangju, 61469
Man Seok Park
- Not yet recruiting
Hallym University Dongtan Sacred Heart hospital
Hwaseong, 18450
Hee Jung Mo
- Not yet recruiting
Wonkwang University Hospital
Iksan, 54538
Young Seo Kim
- Recruiting
Gachon University Gil Medical Center
Incheon, 21565
Young Bae Lee
- Not yet recruiting
Inha University Hospital
Incheon, 22332
Hee Kwon Park
- Recruiting
Jeju National University Hospital
Jeju City, 63241
Jae Chul Choi
- Recruiting
Jeonbuk National University Hospital
Jeonju, 54907
Hyun Gu Kang
- Recruiting
Seoul National University Bundang Hospital
Seongnam, 13620
Hee Jun Bae
- Recruiting
Kyunghee University Medical Center
Seoul, 02447
Seong Hyuk Huh
- Recruiting
Korea University Anam Hospital
Seoul, 02841
Seong Wook Yoo
- Recruiting
Seoul National University Hospital
Seoul, 03080
Keun Hwa Jung
- Recruiting
Asan Medical Center
Seoul, 05505
Sun Uck Kwon
- Recruiting
Ewha womans University Seoul Hospital
Seoul, 07804
Tae Jin Song
- Recruiting
Samsung Medical Center
Seoul, 16499
Woo Keun Seo
- Recruiting
Ulsan University Hospital
Ulsan, 44033
Ji Hyun Kwon
- Recruiting
Yongin Severance Hospital
Yŏngin, 16995
Jin Kwon Kim
About this study
Official title: 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
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.
Read the detailed description
Neu2000 was designed as a multi-target neuroprotectant preventing both the NMDA receptor, a Ca2+ -permeable glutamate receptor, and free radicals, two major routes of brain cell death in stroke. Neu2000 is a moderate NR2B-selective NMDA receptor antagonist and spin trapping molecule (=free radical scavenger or antioxidant). Therapeutic potential of Neu2000 has been well demonstrated in four animal models of stroke with better efficacy and therapeutic time windows than either NMDA receptor antagonist or anti-oxidant advanced to clinical trials. In human phase I studies of 165 healthy subjects conducted in the United States and China, Neu2000KWL showed promising safety profiles without any serious adverse events up to a single intravenous infusion of 6000 mg that is far beyond the therapeutic target dose determined in animal models of transient ischemic stroke. Very recently, acute endovascular recanalization therapy has been introduced as the new standard care of care in acute ischemic stroke. The present study is aimed to examine efficacy and safety of Neu2000KWL in acute ischemic stroke patients receiving endovascular thrombectomy within 12 hours of stroke onset. This is a randomized trial, with placebo comparison, of comparing functional outcome at week 12 after 10 times of administration for five days.
- Conditions
- Ischemic Stroke
- Being tested
- Neu2000KWL group, Placebo group
- Keywords
- Neu2000KWL, Neuroprotection, endovascular therapy, glutamate, free radical
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neu2000KWL groupDrug
1st infusion of 750mg in patients receiving endovascular therapy within 12 hours following ischemic stroke onset followed by 9 consecutive infusions of 500 mg at intervals of 12 ± 1 hours, twice a day.
Placebo groupDrug
1st infusion of the same volume of saline in patients receiving endovascular therapy within 12 hours following ischemic stroke onset followed by 9 consecutive infusions of same volume of saline at intervals of 12 ± 1 hours, twice a day
| Study group | Role | What they receive |
|---|---|---|
| Neu2000KWL | Experimental | Not described Receives: Drug: Neu2000KWL group |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
mRS score evaluated at 12 week after the first dose of drug (Nelonemdaz or Placebo).
Measured: week12
Secondary outcomes (7)
Proportion of mRS 0-2 evaluated at week 5 and week 12 after the first dose of drug (Nelonemdaz or Placebo).
Measured: week5, week12
mRS score evaluated at week 5 after the first dose of investigational drug (Nelonemdaz or Placebo).
Measured: week5
Proportion of mRS 0 measured at week 5 and week 12 after the first dose of investigational drug (Nelonemdaz or Placebo).
Measured: week5, week12
Proportion of NIHSS 0-4 evaluated within 24 hours (Within 72 hours if weekend is included), 5 week, 12 week after the last injection of drug. (Evaluating 43 points for deaths)
Measured: 24hour(or 72hour), week5, week12
Volume of Ischemic stroke based on brain MRI diffusion weighted imaging within 24 hours and at week 12. (If MRI is not available, reading will be performed based on CT scan.)
Measured: 24hour, week12
Proportion of Barthel Index≥95 evaluated at week 5 and week 12
Measured: week5, week12
Occurrence rate of Symptomatic intracranial hemorrhage (SICH) described and defined by this study occurring within 24 hours after the last injection
[Definition of Symptomatic intracranial hemorrhage (SICH)] In the case that brain imaging confirms intracranial hemorrhage with neurological deterioration. (NIHSS score≥4 points) neurological deterioration. (NIHSS score≥4 points)
Measured: 24hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start25 Dec 2021
- Primary completionJun 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 496 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GNT Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sun Uck Kwon, MD, PhD, Principal investigator, Department of Neurology Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041010
- Sponsor's protocol ID
- Neu2000KWL-P03
- Acronym
- RODIN
- Status last verified
- Sep 2021
- First submitted
- 2 Sep 2021
- Last updated
- 26 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee JS, Kang HG, Ahn SH, Song TJ, Shin DI, Bae HJ, Kim CH, Heo SH, Cha JK, Lee YB, Kim EG, Park MS, Park HK, Kim J, Yu S, Mo H, Sohn SI, Kwon JH, Kim JG, Kim YS, Choi JC, Hwang YH, Jung KH, Kim SK, Seo WK, Seo JH, Yoo J, Chang JY, Park M, Lee JS, San An C, Gwag BJ, Choi DW, Kwon SU. Nelonemdaz and Patients With Acute Ischemic Stroke and Mechanical Reperfusion: The RODIN Randomized Clinical Trial. JAMA Netw Open. 2025 Jan 2;8(1):e2456535. doi: 10.1001/jamanetworkopen.2024.56535.
PubMed 39874036Lee JS, Lee JS, Gwag BJ, Choi DW, An CS, Kang HG, Song TJ, Ahn SH, Kim CH, Shin DI, Kwon SU. 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. J Stroke. 2023 Jan;25(1):160-168. doi: 10.5853/jos.2022.02453. Epub 2023 Jan 31.
PubMed 36746385
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05041010
- Acronym / sponsor ID
- RODIN / Neu2000KWL-P03
- Conditions
- Ischemic Stroke
- Keywords
- Neu2000KWL, Neuroprotection, endovascular therapy, glutamate, free radical
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 496 participants (estimated)
- Lead sponsor
- GNT PharmaIndustry (pharma, biotech, devices)
- Study start
- 25 Dec 2021 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 10 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Neu2000 was designed as a multi-target neuroprotectant preventing both the NMDA receptor, a Ca2+ -permeable glutamate receptor, and free radicals, two major routes of brain cell death in stroke. Neu2000 is a moderate NR2B-selective NMDA receptor antagonist and spin trapping molecule (=free radical scavenger or antioxidant). Therapeutic potential of Neu2000 has been well demonstrated in four animal models of stroke with better efficacy and therapeutic time windows than either NMDA receptor antagonist or anti-oxidant advanced to clinical trials. In human phase I studies of 165 healthy subjects conducted in the United States and China, Neu2000KWL showed promising safety profiles without any serious adverse events up to a single intravenous infusion of 6000 mg that is far beyond the therapeutic target dose determined in animal models of transient ischemic stroke. Very recently, acute endovascular recanalization therapy has been introduced as the new standard care of care in acute ischemic stroke. The present study is aimed to examine efficacy and safety of Neu2000KWL in acute ischemic stroke patients receiving endovascular thrombectomy within 12 hours of stroke onset. This is a randomized trial, with placebo comparison, of comparing functional outcome at week 12 after 10 times of administration for five days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neu2000KWL | Experimental | Drug: Neu2000KWL group |
| Placebo | Placebo comparator | Drug: Placebo group |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The trial subjects should satisfy all the following criteria.
- Adults≥19 years
- Patients who can start endovascular therapy within 12 hours after the symptomatic onset of Ischemic stroke.
- NIHSS on screening time point ≥ 8 points
- Patients whose general condition was favorable enough to perform daily activities without the help of others one day prior to the ischemic stroke onset (a person with mRS 0 or 1)
Key exclusion criteria (12 listed)
- A patient who meets any one of the conditions below cannot participate in the Clinical trial.
- Patients who meet the following exclusion criteria on imaging of endovascular therapy
- ① Patients whose occlusion location that can cause an acute ischemic stroke in the CTA (CT angiography) image meets under the following conditions: A. Occlusion of bilateral large artery B. Simultaneous infiltration of anterior and posterior circulation
- Patients who have contraindication to contrast media for brain imaging.
- Patients who are receiving renal replacement therapy such as dialysis due to acute or terminal nephropathy at screening point.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neu2000KWL group1st infusion of 750mg in patients receiving endovascular therapy within 12 hours following ischemic stroke onset followed by 9 consecutive infusions of 500 mg at intervals of 12 ± 1 hours, twice a day. | Drug | Neu2000KWL |
| Placebo group1st infusion of the same volume of saline in patients receiving endovascular therapy within 12 hours following ischemic stroke onset followed by 9 consecutive infusions of same volume of saline at intervals of 12 ± 1 hours, twice a day | Drug | Placebo |
Primary outcome
mRS score evaluated at 12 week after the first dose of drug (Nelonemdaz or Placebo).
Time frame: week12
7 secondary outcomes
Proportion of mRS 0-2 evaluated at week 5 and week 12 after the first dose of drug (Nelonemdaz or Placebo).
Time frame: week5, week12
mRS score evaluated at week 5 after the first dose of investigational drug (Nelonemdaz or Placebo).
Time frame: week5
Proportion of mRS 0 measured at week 5 and week 12 after the first dose of investigational drug (Nelonemdaz or Placebo).
Time frame: week5, week12
Proportion of NIHSS 0-4 evaluated within 24 hours (Within 72 hours if weekend is included), 5 week, 12 week after the last injection of drug. (Evaluating 43 points for deaths)
Time frame: 24hour(or 72hour), week5, week12
Volume of Ischemic stroke based on brain MRI diffusion weighted imaging within 24 hours and at week 12. (If MRI is not available, reading will be performed based on CT scan.)
Time frame: 24hour, week12
Proportion of Barthel Index≥95 evaluated at week 5 and week 12
Time frame: week5, week12
Occurrence rate of Symptomatic intracranial hemorrhage (SICH) described and defined by this study occurring within 24 hours after the last injection
Time frame: 24hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
- Derived from this study: PubMed 39874036Lee JS, Kang HG, Ahn SH, Song TJ, Shin DI, Bae HJ, Kim CH, Heo SH, Cha JK, Lee YB, Kim EG, Park MS, Park HK, Kim J, Yu S, Mo H, Sohn SI, Kwon JH, Kim JG, Kim YS, Choi JC, Hwang YH, Jung KH, Kim SK, Seo WK, Seo JH, Yoo J, Chang JY, Park M, Lee JS, San An C, Gwag BJ, Choi DW, Kwon SU. Nelonemdaz and Patients With Acute Ischemic Stroke and Mechanical Reperfusion: The RODIN Randomized Clinical Trial. JAMA Netw Open. 2025 Jan 2;8(1):e2456535. doi: 10.1001/jamanetworkopen.2024.56535.
- Derived from this study: PubMed 36746385Lee JS, Lee JS, Gwag BJ, Choi DW, An CS, Kang HG, Song TJ, Ahn SH, Kim CH, Shin DI, Kwon SU. 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. J Stroke. 2023 Jan;25(1):160-168. doi: 10.5853/jos.2022.02453. Epub 2023 Jan 31.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sun Uck Kwon, MD, PhD principal investigator
Department of Neurology Asan Medical Center
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Neu2000KWL group in people with Ischemic Stroke, run by GNT Pharma at 24 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chun San An (82-31-8005-9910, csan@gntpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mRS score evaluated at 12 week after the first dose of drug (Nelonemdaz or Placebo). (time frame: week12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05041010, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2022.