NCT02831088

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 8 hours following stroke onset. Neu2000KWL will be administered before endovascular treatment.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 13, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

July 13, 2017

Status Verified

December 1, 2016

Enrollment Period

2.5 years

First QC Date

July 3, 2016

Last Update Submit

July 11, 2017

Conditions

Ischemic Stroke

Keywords

Neu2000KWLNeuroprotectionendovascular therapyglutamatefree radical

Outcome Measures

Primary Outcomes (2)

  • Proportional Ratios of study subjects with mRS 0-2 scores at 12 weeks after Neu2000KWL treatment

    12weeks

  • Occurrence rate of cerebral hemorrhagic transformation occurring within 48 hours based on parenchymal hematoma (PH) criteria by ECASS (European Co-operative Acute Stroke Study)-I and II

    12weeks

Secondary Outcomes (5)

  • Distribution changes of mRS scores at 1, 4 and 12 weeks vs baseline (shift analysis)

    1week, 4weeks, 12weeks

  • Ratios of NIHSS 0-2 scores at 1, 4 and 12 weeks vs baseline

    1week, 4weeks, 12weeks

  • Ratios of Barthel index >90 (≥ 95) at 1, 4 and 12 weeks vs baseline

    1week, 4weeks, 12weeks

  • Occurrence rate of cerebral hemorrhagic transformation occurring within Day 4 or Day 5 (Day of the last treatment of the study drug)

    4-5days

  • Occurrence rate of symptomatic intracranial hemorrhage (SICH) described and defined by this study protocol occurring within Day 4 or Day 5 (Day of the last treatment of the study drug)

    4-5days

Study Arms (3)

Neu2000KWL High-dose group

EXPERIMENTAL
Drug: Neu2000KWL High-does group

Neu2000KWL Low-dose group

EXPERIMENTAL
Drug: Neu2000KWL Low-does group

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Neu2000KWL High-does groupDRUG

1st infusion of 750mg in patients receiving endovascular therapy within 8 hours following ischemic stroke onset followed by 9 consecutive infusions of 500 mg at intervals of 12 hours

Also known as: Neu2000KWL is produced by GNT Pharma Pharmaceutical company
Neu2000KWL High-dose group
Neu2000KWL Low-does groupDRUG

1st infusion of 500mg in patients receiving endovascular therapy within 8 hours following ischemic stroke onset followed by 9 consecutive infusions of 250 mg at intervals of 12 hours

Also known as: Neu2000KWL is produced by GNT Pharma Pharmaceutical company
Neu2000KWL Low-dose group
PlaceboDRUG

1st infusion of the same volume of saline in patients receiving endovascular therapy within 8 hours following ischemic stroke onset followed by 9 consecutive infusions of same volume of saline at intervals of 12 hours

Placebo

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults ≥19 years
  • Patients who were presented to hospitals after onset of brain ischemic symptoms from the base of last normal state and can start Endovascular therapy in accordance with standard practice guidelines within 8 hours after the symptom onset.
  • NIHSS scores on screening time point (admission) ≥ 8 points
  • Patients whose activity is possible without the help of others in the gen-eral condition one day before the ischemic stroke onset. and whose Barthel index scores exceed 90 points
  • Patients whose brain CT and CT angiography imaging confirmed acute ischemic stroke and symptomatic intracranial occlusion at screening and whose occlusion site considered the cause of acute ischemic stroke meets the following conditions:
  • ① Carotid T or L type occlusion
  • ② M1 MCA
  • ③ M1-MCA equivalent (two or more M2-MCAs) However, anterior temporal artery is not regarded M2
  • Patients with ASPECTS on Brain CT without early imaging hyper-enhancement ≥ 6
  • Patients who spontaneously submitted a written informed consent to participation on this clinical study

You may not qualify if:

  • a medical history of hypersensitivity against aspirin (salicylates), sulfasalazine or (5-ASA) at screening.
  • Patients whose imaging shows that the site of occlusion considered the cause of acute ischemic stroke meets the following conditions:
  • A. MCA + PCA or MCA+ACA occlusion in Carotid T/L B. occlusion of a bilateral large artery C. simultaneous infiltration of anterior and posterior circulation
  • ② absence of the collateral circulation corresponding to one of the followings: A. On CT angiography (MIP-CTA) imaging, absence or minimal collateral circulation at ≥50% of MCA territories, compared with pial filling of contralateral side of the lesion.
  • Patients whose heart diseases corresponding to following conditions were confirmed at screening:
  • ① Patients who were diagnosed with myocardial infarction within 6 months at screening
  • ② Patients who had severe arrhythmia evoking clinical symptoms (respiratory difficulties, tachycardia etc.) within 6 months at screening.
  • Patients whose ECG measured at the stable state at emergency room confirmed the following results:
  • A. pulse rate \< 50 or \>120 beats per minute B. 2nd or 3rd degree AV block is confirmed. C. congenital or acquired QT syndrome is confirmed D. ventricular pre-excitation syndrome is confirmed
  • Patients who were diagnosed with heart failure ≥ class II according to "heart failure classification by NYHA (New York Heart Association)" before screening.
  • "heart failure classification by NYHA (New York Heart Association)" Class I: patients with no limitation of activities; they suffer no symptoms from ordinary activities.
  • Class II: patients with slight, mild limitation of activity; they are comfortable with rest or with mild exertion.
  • Class III: patients with marked limitation of activity; they are comfortable only at rest.
  • Class IV: patients who should be at complete rest, confined to bed or chair; any physical activity brings on.
  • Patients who have contraindication to contrast media for brain imaging
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Chungbuk National University Hospital

Cheongju-si, 28644, South Korea

RECRUITING

Keimyung University Dongsan Medical Center

Daegu, 41931, South Korea

RECRUITING

Kyungpook National University Hospital

Daegu, 41944, South Korea

RECRUITING

Chosun University Hospital

Gwangju, 61453, South Korea

RECRUITING

Gachon University Gil Medical Center

Incheon, 21565, South Korea

RECRUITING

Ajou University Hospital

Seoul, 16499, South Korea

RECRUITING

Related Publications (2)

  • Hong JM, Lee JS, Lee YB, Shin DH, Shin DI, Hwang YH, Ahn SH, Kim JG, Sohn SI, Kwon SU, Lee JS, Gwag BJ, Chamorro A, Choi DW; SONIC Investigators. Nelonemdaz for Patients With Acute Ischemic Stroke Undergoing Endovascular Reperfusion Therapy: A Randomized Phase II Trial. Stroke. 2022 Nov;53(11):3250-3259. doi: 10.1161/STROKEAHA.122.039649. Epub 2022 Sep 6.

    PMID: 36065810DERIVED

  • Hong JM, Choi MH, Sohn SI, Hwang YH, Ahn SH, Lee YB, Shin DI, Chamorro A, Choi DW; on the behalf of the SONIC investigators. Safety and Optimal Neuroprotection of neu2000 in acute Ischemic stroke with reCanalization: study protocol for a randomized, double-blinded, placebo-controlled, phase-II trial. Trials. 2018 Jul 13;19(1):375. doi: 10.1186/s13063-018-2746-9.

    PMID: 30005644DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Ji Man Hong, MD, PhD

    Ajou University Medical Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun San An

CONTACT

82-31-8005-9910csan@gntpharma.com

Sung Ig Cho

CONTACT

82-31-8005-9910sicho@gntpharma.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2016

First Posted

July 13, 2016

Study Start

July 1, 2016

Primary Completion

December 30, 2018

Study Completion

December 30, 2018

Last Updated

July 13, 2017

Record last verified: 2016-12

Locations

KR(6)