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Cardiac ArrestPhase 2AWAKENCT03651557

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

A Phase 2 study testing Neu2000KWL High-dose group and Neu2000KWL Low-dose group in people with Cardiac Arrest, run by GNT Pharma at 6 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 80 years
Conditions the study is for
Cardiac Arrest
What is being tested?
Neu2000KWL High-dose group and Neu2000KWL Low-dose group
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
6 sitesSouth Korea
Study dates
29 Nov 2018to May 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 19 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

South Korea6 sites

  • Soonchunhyang University Bucheon Hospital

    Bucheon-si, 14584

  • Pusan National University Hospital

    Busan, 49241

  • Kyungpook National University Hospital

    Daegu, Korea, 41944

  • Chonnam National University Hospital

    Gwangju, 61469

  • Gangnam Severance Hospital

    Seoul, 06273

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

About this study

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

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.

Read the 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.

Conditions
Cardiac Arrest
Being tested
Neu2000KWL High-dose group, Neu2000KWL Low-dose group, Placebo
Keywords
Neu2000KWL, cerebral performance category, out-of-hospital cardiac arrest, neuroprotection, glutamate, N-Methyl-D-aspartate (NMDA) receptor antagonist, Anti-oxidant, free radical
Medical subject headings
Heart Arrest, Out-of-Hospital Cardiac Arrest

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neu2000KWL High-dose groupDrug

    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 Low-dose groupDrug

    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.)

  • PlaceboDrug

    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

Study groups in NCT03651557
Study groupRoleWhat they receive
Neu2000KWL high doseExperimentalNot described
Receives: Drug: Neu2000KWL High-dose group
Neu2000KWL low doseExperimentalNot described
Receives: Drug: Neu2000KWL Low-dose group
salinePlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Blood concentration of neuron specific enolase (NSE)

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

Secondary outcomes (6)

  1. 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)

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

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

    The difference of blood neuron specific enolase (NSE) between 24 hour (day 1) and 72 hour (day 3) after the first infusion of Neu2000KWL.

    Measured: At the 24 hours and 72 hours 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

    The difference of blood neuron specific enolase (NSE) between day 4 and day 5

    Measured: 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).

  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

    Blood neuron specific enolase (NSE) at day 5

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

  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.

    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)

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

  6. Verification of difference between groups of Cumulative value of blood S100beta from 6th infusion after 1st infusion of Neu2000KWL.

    Cumulative blood concentration of S100beta .

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2018
  2. Study start29 Nov 2018
  3. Primary completionMay 2021 (estimated)
  4. Study completionMay 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03651557
Sponsor's protocol ID
Neu2000KWL-P02
Acronym
AWAKE
Status last verified
Aug 2018
First submitted
26 Jul 2018
Last updated
6 Mar 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 39899673

  • 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.

    PubMed 35871083

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Neu2000KWL High-dose group and Neu2000KWL Low-dose group in people with Cardiac Arrest, run by GNT Pharma at 6 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03651557, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2019.

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