Rescues On Reperfusion Damage In Cerebral Infarction by Nelonemdaz

Last updated: September 23, 2022
Sponsor: GNT Pharma
Overall Status: Active - Recruiting

Phase

3

Condition

Stroke

Thrombosis

Cerebral Ischemia

Treatment

N/A

Clinical Study ID

NCT05041010
Neu2000KWL-P03
  • Ages > 19
  • All Genders

Study 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. Neu2000KWL will be administered before endovascular treatment.

Eligibility Criteria

Inclusion

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 symptomaticonset of Ischemic stroke.
  3. NIHSS on screening time point ≥ 8 points
  4. Patients whose general condition was favorable enough to perform daily activitieswithout the help of others one day prior to the ischemic stroke onset (a person withmRS 0 or 1)
  5. Patients whose CTA or MRA confirmed internal carotid artery occlusion and M1 or M2occlusion of the middle cerebral artery, that are the types of major cerebral arteryocclusion that can cause acute cerebral infarction and are subject to endovasculartherapy.
  6. Patients with early ASPECTS point≥4 (Noncontrast brain cross-section CT or Braincross-section MRI diffusion weighted imaging)
  7. Patients who spontaneously submitted a written informed consent to participation onthis clinical study.

Exclusion

Exclusion Criteria: A patient who meets any one of the conditions below cannot participate in the Clinicaltrial.

  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 bilaterallarge 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 orterminal nephropathy at screening point.
  4. Patients who were diagnosed with cancer or received cancer therapy within 6 months atscreening or have recurrent or transitional cancer.
  5. Patients have high body temperature of 38oC or more and need antibiotic therapy due tomedical opinion of infectious disease at screening.
  6. Patients who are having pharmacotherapy due to liver diseases such as hepaticcirrhosis, etc. at screening point.
  7. Patients who are pregnant or lactating. However, only a woman who has no possibilityof pregnancy can participate in this clinical research. Woman with child-bearing potential can be defined as the woman who has not had theclear 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 thescreening 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 toother reasons

Study Design

Total Participants: 496
Study Start date:
December 25, 2021
Estimated Completion Date:
January 31, 2025

Study 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.

Connect with a study center

  • Dong-A University Hospital

    Busan, 49201
    Korea, Republic of

    Active - Recruiting

  • Inje University Busan Paik Hospital

    Busan, 47392
    Korea, Republic of

    Active - Recruiting

  • Gyeongsang National University Hospital

    Changwon, 52727
    Korea, Republic of

    Active - Recruiting

  • Chungbuk National University Hospital

    Cheongju-si, 28644
    Korea, Republic of

    Active - Recruiting

  • Keimyung University Dongsan Medical Center

    Daegu, 42601
    Korea, Republic of

    Active - Recruiting

  • Kyungpook National University Hospital

    Daegu, 41944
    Korea, Republic of

    Active - Recruiting

  • Daejeon Eulji Medical Center, Eulji University

    Daejeon, 35233
    Korea, Republic of

    Active - Recruiting

  • Chonnam National University Hospital

    Gwangju, 61469
    Korea, Republic of

    Active - Recruiting

  • Chosun University Hospital

    Gwangju, 61453
    Korea, Republic of

    Active - Recruiting

  • Hallym University Dongtan Sacred Heart hospital

    Hwaseong, 18450
    Korea, Republic of

    Site Not Available

  • Wonkwang University Hospital

    Iksan, 54538
    Korea, Republic of

    Site Not Available

  • Gachon University Gil Medical Center

    Incheon, 21565
    Korea, Republic of

    Active - Recruiting

  • Inha University Hospital

    Incheon, 22332
    Korea, Republic of

    Site Not Available

  • Jeju National University Hospital

    Jeju, 63241
    Korea, Republic of

    Active - Recruiting

  • Jeonbuk National University Hospital

    Jeonju, 54907
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Bundang Hospital

    Seongnam, 13620
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Ewha womans University Seoul Hospital

    Seoul, 07804
    Korea, Republic of

    Active - Recruiting

  • Korea University Anam Hospital

    Seoul, 02841
    Korea, Republic of

    Active - Recruiting

  • Kyunghee University Medical Center

    Seoul, 02447
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 16499
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Ajou University Hospital

    Suwon, 16499
    Korea, Republic of

    Site Not Available

  • Ulsan University Hospital

    Ulsan, 44033
    Korea, Republic of

    Active - Recruiting

  • Yongin Severance Hospital

    Yongin, 16995
    Korea, Republic of

    Active - Recruiting

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