Safety and Optimal Neuroprotection of neu2000 in Ischemic Stroke With Endovascular reCanalizion (SONIC) "SONIC"

Recruiting

Phase 2 Results N/A

Trial Description

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.

Detailed Description

Neu2000 was designed as a multi-target neuroprotectant preventing both the NMDA receptor, a Ca2+-permeable glutamate receptor, and free radicals, two major routes of brain cell death in stroke. Neu2000 is a moderate NR2B-selective NMDA receptor antagonist and spin trapping molecule (=free radical scavenger or antioxidant). Therapeutic potential of Neu2000 has been well demonstrated in four animal models of stroke with better efficacy and therapeutic time windows than either NMDA receptor antagonist or anti-oxidant advanced to clinical trials. In human phase I studies of 165 healthy subjects conducted in the United States and China, Neu2000KWL showed promising safety profiles without any serious adverse events up to a single intravenous infusion of 6000 mg that is far beyond the therapeutic target dose determined in animal models of transient ischemic stroke. Very recently, acute endovascular recanalization therapy has been introduced as the new standard care of care in acute ischemic stroke. The present study is aimed to examine efficacy and safety of Neu2000KWL in acute ischemic stroke patients receiving endovascular thrombectomy within 8 hours of stroke onset.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: Placebo
  • Neu2000KWL High-does group Drug
    Other Names: Neu2000KWL is produced by GNT Pharma Pharmaceutical company
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: Neu2000KWL High-dose group
  • Neu2000KWL Low-does group Drug
    Other Names: Neu2000KWL is produced by GNT Pharma Pharmaceutical company
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: Neu2000KWL Low-dose group

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Ratios of study subjects with mRS 0-2 scores at 5 days, 4 and 12 weeks after first Neu2000KWL treatment vs baseline 5days, 4weeks, 12weeks Yes
Secondary Distribution changes of mRS scores at 1, 4 and 12 weeks vs baseline (shift analysis) 1week, 4weeks, 12weeks Yes
Secondary Ratios of NIHSS 0-2 scores at 1, 4 and 12 weeks vs baseline 1week, 4weeks, 12weeks Yes
Secondary Ratios of Barthel index >90 (≥ 95) at 1, 4 and 12 weeks vs baseline 1week, 4weeks, 12weeks Yes
Secondary Occurrence rate of cerebral hemorrhagic transformation occurring within Day 4 or Day 5 (Day of the last treatment of the study drug) 4-5days Yes
Secondary 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 Yes
Primary Proportional Ratios of study subjects with mRS 0-2 scores at 12 weeks after Neu2000KWL treatment 12weeks
Primary 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

Sponsors