Antioxidant and NMDA Receptor Blocker Wins Anoxic Brain Damage of KorEa OHCA Patients

NCT03651557 | Unknown Phase 2 DMC

• 1 other identifier: Neu2000KWL-P02
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 6

Brief Summary

This study aims to investigate the efficacy and safety of Neu2000KWL, a neuroprotectant, in patients resuscitated from out-of-hospital cardiac arrest and receiving therapeutic hypothermia.

Conditions

Cardiac Arrest

Keywords

Neu2000KWL; cerebral performance category; out-of-hospital cardiac arrest; neuroprotection; glutamate; N-Methyl-D-aspartate (NMDA) receptor antagonist; Anti-oxidant; free radical

Outcome Measures

Primary Outcomes (1)

• Verification of difference between of Neuron specific enolase (NSE) value at after 4th infusion of Neu2000KWL.

  Blood concentration of neuron specific enolase (NSE)

  The 3rd day of study (which corresponds to finished 4th infusion of Neu2000KWL).

Secondary Outcomes (6)

• Verification of difference between the cumulative of neuron specific enolase (NSE) values at after 6th infusion of Neu2000KWL

  The 4th day of study (which corresponds to finished 6th infusion of Neu2000KWL).

• Verification of the difference between groups of Change in NSE values at after the 2nd infusion of Neu2000KWL and after the 6th infusion

  At the 24 hours and 72 hours after the first infusion of Neu2000KWL.

• Verification of difference between each group of NSE values at after 6th infusion after 1st infusion of Neu2000KWL and 24 hours after end of last infusion

  The 4th and 5th day of study (which corresponds to the timepoint of finished treatment using Neu2000KWL and 24 hour after finished treatment using Neu2000KWL).

• Verification of difference between the cerebral infarction at analysis of brain MRI's Apparent Diffusion Coefficient(ADC) images within 48 hours of the last infusion of Neu2000KWL

  The 5th day of study (which corresponds to 48 hours after finished treatment using Neu2000KWL).

• Verification of difference between groups of Neurological function evaluated by cerebral performance category (CPC) and modified Rankin Scale (mRS) at 5 day, 14 day, or discharge within 14 days, and 90 days after 1st infusion of Neu2000KWL.

  5 day, 14 day, or discharge within 14 days, and 90 days after 1st infusion of Neu2000KWL

Other Outcomes (2)

• Serious adverse event

  90 days

• Mortality within 90 days

  90 days

Study Arms (3)

Neu2000KWL high dose

EXPERIMENTAL

Drug: Neu2000KWL High-dose group

Neu2000KWL low dose

EXPERIMENTAL

Drug: Neu2000KWL Low-dose group

saline

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Neu2000KWL High-dose group DRUG

1st infusion of 1500mg in patients within 4 hours following sudden cardiac arrest onset followed by 5 consecutive infusions of 750 mg at intervals of 12 hours(Total drug dosage is 5250mg.)

Neu2000KWL high dose

Neu2000KWL Low-dose group DRUG

1st infusion of 750mg in patients within 4 hours following sudden cardiac arrest onset followed by 5 consecutive infusions of 500 mg at intervals of 12 hours (Total drug dosage is 3250mg.)

Neu2000KWL low dose

Placebo DRUG

1st infusion of the same volume of saline in patients within 4 hours following sudden cardiac arrest onset followed by 5 consecutive infusions of the same volume of saline at intervals of 12 hours

saline

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Years to 80 Years (Adult)
• Out-of-hospital cardiac arrest caused by non-perfusing cardiac rhythm
• Successful resuscitation accompanied by ROSC time of more than 20 min
• Therapeutic hypothermia is planned or initiated
• The first infusion is planned within 4 hours after ROSC
• Informed consent is obtained from patient or family member(s)
• No concern with previous cardiovascular surgery

You may not qualify if:

• Hypersensitivity to aspirin or sulfasalazine
• Unwitnessed cardiac arrest
• CPR time \> 60 min
• Therapeutic hypothermia is not planned
• Use of extracorporeal membrane oxygenation (ECMO) at initiation of in-hospital resuscitation (E-CPR)
• Very poor prognosis is expected: patients with (A) non-cardiac or respiratory arrest, (B) poor basal neurological status (C) secondary cardiac arrest caused by trauma, major bleeding, acute neurologic disease including stroke or tumor, (D) multiorgan failure or advanced malignancy
• Pregnant or lactating women
• Participated in other clinical studies within 90 days before randomization; or participating in other clinical trials at present
• Intracranial bleeding verified by first brain CT imaging
• The investigators consider the patients are not suitable for this trial

Sponsors & Collaborators

• GNT Pharma: lead
• Samsung Medical Center: collaborator
• Chonnam National University Hospital: collaborator
• Gangnam Severance Hospital: collaborator
• Kyungpook National University Hospital: collaborator
• Pusan National University Hospital: collaborator
• Soonchunhyang University Hospital: collaborator

Study Sites (6)

Kyungpook National University Hospital

Daegu, Korea, 41944, South Korea

Location

Soonchunhyang University Bucheon Hospital

Bucheon-si, 14584, South Korea

Location

Pusan National University Hospital

Busan, 49241, South Korea

Location

Chonnam National University Hospital

Gwangju, 61469, South Korea

Location

Gangnam Severance Hospital

Seoul, 06273, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Related Publications (2)

• Chun BJ, Yeom SR, Chung SP, Lee YH, Lee J, Kim YH, Lee JS, Lee JS, An CS, Gwag BJ, Choi JH. Nelonemdaz Treatment for Patients With Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial. Crit Care Med. 2025 Apr 1;53(4):e772-e782. doi: 10.1097/CCM.0000000000006579. Epub 2025 Jan 14.

  PMID: 39899673 DERIVED

• Choi JH, Chun BJ, Yeom SR, Chung SP, Lee YH, Kim YH, Lee JS, Lee JH, Lee HG, Jin JY, An CS, Gwag BJ. Rationale and methods of the Antioxidant and NMDA receptor blocker Weans Anoxic brain damage of KorEa OHCA patients (AWAKE) trial. Trials. 2022 Jul 23;23(1):587. doi: 10.1186/s13063-022-06452-0.

  PMID: 35871083 DERIVED

MeSH Terms

Conditions

Heart Arrest; Out-of-Hospital Cardiac Arrest

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Jin-Ho Choi, MD

  Professor, Department of Emergency Medicine, Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double Blind (Subject, Caregiver, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 29, 2018
• Study Start: November 29, 2018
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: March 6, 2019

Record last verified: 2018-08

Locations

KR (6)