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| Name | Class |
|---|---|
| Samsung Medical Center | OTHER |
| Chonnam National University Hospital | OTHER |
| Gangnam Severance Hospital | OTHER |
| Kyungpook National University Hospital |
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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.
Lack of good neurological recovery is the biggest hurdle in the treatment of out-of-hospital cardia arrest. Neu2000KWL, a N-Methyl-D-aspartate (NMDA) receptor antagonist and an antioxidant, attenuated cerebral neuronal death and reduced hypoxic injury of brain in preclinical studies. Phase I clinical study has revealed that Neu2000KWL is very safe for treating human. In current study, the investigators will assess the efficacy of Neu2000KWL to compare the neurological biomarker, brain imaging, and clinical outcomes of patients successfully resuscitated from out-of-cardiac arrest treated by 3-day infusion of Neu2000KWL with patients assigned to placebo arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neu2000KWL high dose | Experimental |
| |
| Neu2000KWL low dose | Experimental |
| |
| saline | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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.) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Verification of difference between the cumulative of neuron specific enolase (NSE) values at after 6th infusion of Neu2000KWL | Cumulative Blood concentration of neuron specific enolase (NSE) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Serious adverse event | Safety Outcome Measure Number of participants with treatment-related adverse events assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 | 90 days |
| Mortality within 90 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jin-Ho Choi, MD | Professor, Department of Emergency Medicine, Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook National University Hospital | Daegu | Korea | 41944 | South Korea | ||
| Soonchunhyang University Bucheon Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39899673 | Derived | 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. | |
| 35871083 | 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. |
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D058687 | Out-of-Hospital Cardiac Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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| OTHER |
| Pusan National University Hospital | OTHER |
| Soonchunhyang University Hospital | OTHER |
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Double Blind (Subject, Caregiver, Investigator)
| 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.) |
|
| 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 |
|
The difference of blood neuron specific enolase (NSE) between 24 hour (day 1) and 72 hour (day 3) after the first infusion of Neu2000KWL. |
| 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 difference of blood neuron specific enolase (NSE) between day 4 and day 5 | 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 | Blood neuron specific enolase (NSE) at day 5 | 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. | Neurological function evaluated by cerebral performance category (CPC), which ranges 1 to 5 (1: best, 5: worst), and neurological function evaluated by modified Rankin Scale (mRS), which ranges 0 to 6 (0:best, 6: worst) | 5 day, 14 day, or discharge within 14 days, and 90 days after 1st infusion of Neu2000KWL |
| Verification of difference between groups of Cumulative value of blood S100beta from 6th infusion after 1st infusion of Neu2000KWL. | Cumulative blood concentration of S100beta . | The 4th day of study (which corresponds to finished 6th infusion of Neu2000KWL). |
Safety Outcome Measure
| 90 days |
| Bucheon-si |
| 14584 |
| South Korea |
| Pusan National University Hospital | Busan | 49241 | South Korea |
| Chonnam National University Hospital | Gwangju | 61469 | South Korea |
| Gangnam Severance Hospital | Seoul | 06273 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |