Rescues On Reperfusion Damage In Cerebral Infarction by Nelonemdaz (RODIN)

September 23, 2022 updated by: GNT Pharma

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
496

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 49201
        • Recruiting
        • Dong-A University Hospital
        • Principal Investigator:
          • Jae Gwan Cha
      • Busan, Korea, Republic of, 47392
        • Recruiting
        • Inje University Busan Paik Hospital
        • Principal Investigator:
          • Eung Gyu Kim
      • Changwon, Korea, Republic of, 52727
        • Recruiting
        • GyeongSang National University Hospital
        • Principal Investigator:
          • Soo Kyoung Kim
      • Cheongju-si, Korea, Republic of, 28644
        • Recruiting
        • Chungbuk National University Hospital
        • Principal Investigator:
          • Dong Ick Shin
      • Daegu, Korea, Republic of, 42601
        • Recruiting
        • Keimyung University Dongsan Medical Center
        • Principal Investigator:
          • Sung Il Sohn
      • Daegu, Korea, Republic of, 41944
        • Recruiting
        • Kyungpook National University Hospital
        • Principal Investigator:
          • Yang Ha Hwang
      • Daejeon, Korea, Republic of, 35233
        • Recruiting
        • Daejeon Eulji Medical Center, Eulji University
        • Principal Investigator:
          • Jae Kook Kim
      • Gwangju, Korea, Republic of, 61469
        • Recruiting
        • Chonnam National University Hospital
        • Principal Investigator:
          • Man Seok Park
      • Gwangju, Korea, Republic of, 61453
        • Recruiting
        • Chosun university hospital
        • Principal Investigator:
          • Seong Hwan Ahn
      • Hwaseong, Korea, Republic of, 18450
        • Not yet recruiting
        • Hallym University Dongtan Sacred Heart Hospital
        • Principal Investigator:
          • Hee Jung Mo
      • Iksan, Korea, Republic of, 54538
        • Not yet recruiting
        • Wonkwang University Hospital
        • Principal Investigator:
          • Young Seo Kim
      • Incheon, Korea, Republic of, 21565
        • Recruiting
        • Gachon University Gil Medical Center
        • Principal Investigator:
          • Young Bae Lee
      • Incheon, Korea, Republic of, 22332
        • Not yet recruiting
        • Inha University Hospital
        • Principal Investigator:
          • Hee Kwon Park
      • Jeju, Korea, Republic of, 63241
        • Recruiting
        • Jeju National University Hospital
        • Principal Investigator:
          • Jae Chul Choi
      • Jeonju, Korea, Republic of, 54907
        • Recruiting
        • Jeonbuk National University Hospital
        • Principal Investigator:
          • Hyun Gu Kang
      • Seongnam, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Principal Investigator:
          • Hee Jun Bae
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
        • Principal Investigator:
          • Keun Hwa Jung
      • Seoul, Korea, Republic of, 05505
        • Recruiting
        • Asan Medical Center
        • Principal Investigator:
          • Sun Uck Kwon
      • Seoul, Korea, Republic of, 02447
        • Recruiting
        • Kyunghee University Medical Center
        • Principal Investigator:
          • Seong Hyuk Huh
      • Seoul, Korea, Republic of, 02841
        • Recruiting
        • Korea University Anam Hospital
        • Principal Investigator:
          • Seong Wook Yoo
      • Seoul, Korea, Republic of, 07804
        • Recruiting
        • Ewha Womans University Seoul Hospital
        • Principal Investigator:
          • Tae Jin Song
      • Seoul, Korea, Republic of, 16499
        • Recruiting
        • Samsung Medical Center
        • Principal Investigator:
          • Woo Keun Seo
      • Ulsan, Korea, Republic of, 44033
        • Recruiting
        • Ulsan University Hospital
        • Principal Investigator:
          • Ji Hyun Kwon
      • Yongin, Korea, Republic of, 16995
        • Recruiting
        • Yongin Severance Hospital
        • Principal Investigator:
          • Jin Kwon Kim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

The trial subjects should satisfy all the following criteria.

  1. Adults≥19 years
  2. Patients who can start endovascular therapy within 12 hours after the symptomatic onset of Ischemic stroke.
  3. NIHSS on screening time point ≥ 8 points
  4. 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)
  5. 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.
  6. Patients with early ASPECTS point≥4 (Noncontrast brain cross-section CT or Brain cross-section MRI diffusion weighted imaging)
  7. Patients who spontaneously submitted a written informed consent to participation on this clinical study.

Exclusion Criteria:

A patient who meets any one of the conditions below cannot participate in the Clinical trial.

  1. 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

  2. Patients who have contraindication to contrast media for brain imaging.
  3. Patients who are receiving renal replacement therapy such as dialysis due to acute or terminal nephropathy at screening point.
  4. Patients who were diagnosed with cancer or received cancer therapy within 6 months at screening or have recurrent or transitional cancer.
  5. Patients have high body temperature of 38oC or more and need antibiotic therapy due to medical opinion of infectious disease at screening.
  6. Patients who are having pharmacotherapy due to liver diseases such as hepatic cirrhosis, etc. at screening point.

  7. 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.

  8. 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.
  9. Patients who are determined unsuitable for participation in this clinical trial due to other reasons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo group
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
Experimental: Neu2000KWL
Drug: Neu2000KWL group
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
mRS score evaluated at 12 week after the first dose of drug (Nelonemdaz or Placebo).
Time Frame: week12
week12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
week5, week12
mRS score evaluated at week 5 after the first dose of investigational drug (Nelonemdaz or Placebo).
Time Frame: week5
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
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
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
24hour, week12
Proportion of Barthel Index≥95 evaluated at week 5 and week 12
Time Frame: week5, week12
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
[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)
24hour

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Proportion of adverse events and serious adverse events
Time Frame: day0~week12
day0~week12
All mortality rate until 12 weeks
Time Frame: day0~week12
day0~week12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GNT Pharma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sun Uck Kwon, MD, PhD, Department of Neurology Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 25, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Neu2000KWL-P03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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