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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03651557
Recruitment Status : Unknown
Verified August 2018 by GNT Pharma.
Recruitment status was:  Enrolling by invitation
First Posted : August 29, 2018
Last Update Posted : March 6, 2019
Sponsor:
Collaborators:
Samsung Medical Center
Chonnam National University Hospital
Gangnam Severance Hospital
Kyungpook National University Hospital
Pusan National University Hospital
Soonchunhyang University Hospital
Information provided by (Responsible Party):
GNT Pharma

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cardiac Arrest Drug: Neu2000KWL High-dose group Drug: Neu2000KWL Low-dose group Drug: Placebo Phase 2

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II, Double-blind, Randomized, Placebo-controlled, Multicenter Trial to Assess the Efficacy and Safety of Neu2000KWL in Patients Who Resuscitated After Out-of-hospital Cardiac Arrest Patient and Receiving Therapeutic Hypothermia
Actual Study Start Date : November 29, 2018
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Neu2000KWL high dose Drug: Neu2000KWL High-dose group
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.)
Experimental: Neu2000KWL low dose Drug: Neu2000KWL Low-dose group
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 Comparator: saline Drug: Placebo
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


Outcome Measures
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Primary Outcome Measures :
  1. Verification of difference between of Neuron specific enolase (NSE) value at after 4th infusion of Neu2000KWL. [ Time Frame: The 3rd day of study (which corresponds to finished 4th infusion of Neu2000KWL). ]
    Blood concentration of neuron specific enolase (NSE)


Secondary Outcome Measures :
  1. Verification of difference between the cumulative of neuron specific enolase (NSE) values at after 6th infusion of Neu2000KWL [ Time Frame: The 4th day of study (which corresponds to finished 6th infusion of Neu2000KWL). ]
    Cumulative Blood concentration of neuron specific enolase (NSE)

  2. Verification of the difference between groups of Change in NSE values at after the 2nd infusion of Neu2000KWL and after the 6th infusion [ Time Frame: At the 24 hours and 72 hours after the first infusion of Neu2000KWL. ]
    The difference of blood neuron specific enolase (NSE) between 24 hour (day 1) and 72 hour (day 3) after the first infusion of Neu2000KWL.

  3. 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 [ Time Frame: 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). ]
    The difference of blood neuron specific enolase (NSE) between day 4 and day 5

  4. 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 [ Time Frame: The 5th day of study (which corresponds to 48 hours after finished treatment using Neu2000KWL). ]
    Blood neuron specific enolase (NSE) at day 5

  5. 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. [ Time Frame: 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)

  6. Verification of difference between groups of Cumulative value of blood S100beta from 6th infusion after 1st infusion of Neu2000KWL. [ Time Frame: The 4th day of study (which corresponds to finished 6th infusion of Neu2000KWL). ]
    Cumulative blood concentration of S100beta .


Other Outcome Measures:
  1. Serious adverse event [ Time Frame: 90 days ]

    Safety Outcome Measure

    Number of participants with treatment-related adverse events assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0


  2. Mortality within 90 days [ Time Frame: 90 days ]
    Safety Outcome Measure


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 19 Years to 80 Years (Adult)
  2. Out-of-hospital cardiac arrest caused by non-perfusing cardiac rhythm
  3. Successful resuscitation accompanied by ROSC time of more than 20 min
  4. Therapeutic hypothermia is planned or initiated
  5. The first infusion is planned within 4 hours after ROSC
  6. Informed consent is obtained from patient or family member(s)
  7. No concern with previous cardiovascular surgery

Exclusion Criteria:

  1. Hypersensitivity to aspirin or sulfasalazine
  2. Unwitnessed cardiac arrest
  3. CPR time > 60 min
  4. Therapeutic hypothermia is not planned
  5. Use of extracorporeal membrane oxygenation (ECMO) at initiation of in-hospital resuscitation (E-CPR)
  6. 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
  7. Pregnant or lactating women
  8. Participated in other clinical studies within 90 days before randomization; or participating in other clinical trials at present
  9. Intracranial bleeding verified by first brain CT imaging
  10. The investigators consider the patients are not suitable for this trial
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03651557


Locations
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Korea, Republic of
Kyungpook National University Hospital
Daegu, Korea, Korea, Republic of, 41944
Soonchunhyang University Bucheon Hospital
Bucheon, Korea, Republic of, 14584
Pusan National University Hospital
Busan, Korea, Republic of, 49241
Chonnam National University Hospital
Gwangju, Korea, Republic of, 61469
Gangnam Severance Hospital
Seoul, Korea, Republic of, 06273
Samsung Medical Center
Seoul, Korea, Republic of, 06351
Sponsors and Collaborators
GNT Pharma
Samsung Medical Center
Chonnam National University Hospital
Gangnam Severance Hospital
Kyungpook National University Hospital
Pusan National University Hospital
Soonchunhyang University Hospital
Investigators
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Principal Investigator: Jin-Ho Choi, MD Professor, Department of Emergency Medicine, Samsung Medical Center
More Information
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Responsible Party: GNT Pharma
ClinicalTrials.gov Identifier: NCT03651557    
Other Study ID Numbers: Neu2000KWL-P02
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GNT Pharma:
Neu2000KWL
cerebral performance category
out-of-hospital cardiac arrest
neuroprotection
 glutamate
N-Methyl-D-aspartate (NMDA) receptor antagonist
Anti-oxidant
free radical
Additional relevant MeSH terms:
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Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases
Salicylates
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action