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

Primary Purpose

Ischemic Stroke

Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Neu2000KWL group
Placebo group
Sponsored by
GNT Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring Neu2000KWL, Neuroprotection, endovascular therapy, glutamate, free radical

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Inje University Busan Paik HospitalRecruiting
  • Dong-A University HospitalRecruiting
  • Gyeongsang National University HospitalRecruiting
  • Chungbuk National University HospitalRecruiting
  • Kyungpook National University HospitalRecruiting
  • Keimyung University Dongsan Medical CenterRecruiting
  • Daejeon Eulji Medical Center, Eulji UniversityRecruiting
  • Chosun University HospitalRecruiting
  • Chonnam National University HospitalRecruiting
  • Hallym University Dongtan Sacred Heart hospital
  • Wonkwang University Hospital
  • Gachon University Gil Medical CenterRecruiting
  • Inha University Hospital
  • Jeju National University HospitalRecruiting
  • Jeonbuk National University HospitalRecruiting
  • Seoul National University Bundang HospitalRecruiting
  • Kyunghee University Medical CenterRecruiting
  • Korea University Anam HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Asan Medical CenterRecruiting
  • Ewha womans University Seoul HospitalRecruiting
  • Samsung Medical CenterRecruiting
  • Ulsan University HospitalRecruiting
  • Yongin Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Neu2000KWL

Placebo

Arm Description

Outcomes

Primary Outcome Measures

mRS score evaluated at 12 week after the first dose of drug (Nelonemdaz or Placebo).

Secondary Outcome Measures

Proportion of mRS 0-2 evaluated at week 5 and week 12 after the first dose of drug (Nelonemdaz or Placebo).
mRS score evaluated at week 5 after the first dose of investigational drug (Nelonemdaz or Placebo).
Proportion of mRS 0 measured at week 5 and week 12 after the first dose of investigational drug (Nelonemdaz or Placebo).
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)
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.)
Proportion of Barthel Index≥95 evaluated at week 5 and week 12
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)

Full Information

First Posted
September 2, 2021
Last Updated
September 23, 2022
Sponsor
GNT Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT05041010
Brief Title
Rescues On Reperfusion Damage In Cerebral Infarction by Nelonemdaz
Acronym
RODIN
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 25, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GNT Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
Neu2000KWL, Neuroprotection, endovascular therapy, glutamate, free radical

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
496 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neu2000KWL
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Neu2000KWL group
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo group
Intervention Description
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
Primary Outcome Measure Information:
Title
mRS score evaluated at 12 week after the first dose of drug (Nelonemdaz or Placebo).
Time Frame
week12
Secondary Outcome Measure Information:
Title
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
Title
mRS score evaluated at week 5 after the first dose of investigational drug (Nelonemdaz or Placebo).
Time Frame
week5
Title
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
Title
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
Title
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
Title
Proportion of Barthel Index≥95 evaluated at week 5 and week 12
Time Frame
week5, week12
Title
Occurrence rate of Symptomatic intracranial hemorrhage (SICH) described and defined by this study occurring within 24 hours after the last injection
Description
[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)
Time Frame
24hour
Other Pre-specified Outcome Measures:
Title
Proportion of adverse events and serious adverse events
Time Frame
day0~week12
Title
All mortality rate until 12 weeks
Time Frame
day0~week12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chun San An
Phone
82-31-8005-9910
Email
csan@gntpharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sun Uck Kwon, MD, PhD
Organizational Affiliation
Department of Neurology Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inje University Busan Paik Hospital
City
Busan
ZIP/Postal Code
47392
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eung Gyu Kim
Facility Name
Dong-A University Hospital
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae Gwan Cha
Facility Name
Gyeongsang National University Hospital
City
Changwon
ZIP/Postal Code
52727
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soo Kyoung Kim
Facility Name
Chungbuk National University Hospital
City
Cheongju-si
ZIP/Postal Code
28644
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Ick Shin
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Ha Hwang
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
ZIP/Postal Code
42601
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung Il Sohn
Facility Name
Daejeon Eulji Medical Center, Eulji University
City
Daejeon
ZIP/Postal Code
35233
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae Kook Kim
Facility Name
Chosun University Hospital
City
Gwangju
ZIP/Postal Code
61453
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seong Hwan Ahn
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Man Seok Park
Facility Name
Hallym University Dongtan Sacred Heart hospital
City
Hwaseong
ZIP/Postal Code
18450
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hee Jung Mo
Facility Name
Wonkwang University Hospital
City
Iksan
ZIP/Postal Code
54538
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young Seo Kim
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young Bae Lee
Facility Name
Inha University Hospital
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hee Kwon Park
Facility Name
Jeju National University Hospital
City
Jeju
ZIP/Postal Code
63241
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae Chul Choi
Facility Name
Jeonbuk National University Hospital
City
Jeonju
ZIP/Postal Code
54907
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyun Gu Kang
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hee Jun Bae
Facility Name
Kyunghee University Medical Center
City
Seoul
ZIP/Postal Code
02447
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seong Hyuk Huh
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seong Wook Yoo
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keun Hwa Jung
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sun Uck Kwon
Facility Name
Ewha womans University Seoul Hospital
City
Seoul
ZIP/Postal Code
07804
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae Jin Song
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
16499
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Woo Keun Seo
Facility Name
Ulsan University Hospital
City
Ulsan
ZIP/Postal Code
44033
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji Hyun Kwon
Facility Name
Yongin Severance Hospital
City
Yongin
ZIP/Postal Code
16995
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Kwon Kim

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Rescues On Reperfusion Damage In Cerebral Infarction by Nelonemdaz

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