Safety and Efficacy of NA-1 in Subjects Undergoing Endovascular Thrombectomy for Stroke (ESCAPE-NA1) "ESCAPE-NA1"

Recruiting

Phase 3 Results N/A

Trial Description

The ESCAPE-NA-1 study is designed to determine the safety and efficacy of the neuroprotectant, NA-1, in reducing global disability in subjects with major acute ischemic stroke (AIS) with a small established infarct core and with good collateral circulation who are selected for endovascular revascularization.

Detailed Description

Trial Objectives:
The primary objective is to determine the efficacy of the neuroprotectant, NA-1, in reducing global disability in subjects with major acute ischemic stroke (AIS) with a small established infarct core and with good collateral circulation selected for rapid endovascular revascularization.
The secondary objectives are to determine the efficacy of NA-1 in:
- Reducing functional dependence
- Improving neurological outcome
- Improving activities of daily living
- Reducing mortality rate The leading safety objectives are to determine the effect of administering a dose of 2.6 mg/kg intravenous (IV) infusion of NA-1 to subject with acute stroke who are selected for endovascular revascularization on serious adverse events (SAEs) and 90-day mortality.
Trial Design:
This study is a Phase 3, randomized, multicentre, blinded, placebo-controlled, parallel group, single-dose design. Subjects harboring an acute ischemic stroke and who are selected for endovascular revascularization in accordance with local institutional practices and who harbor a small established infarct core and with good collateral circulation will be given a single, 2.6 mg/kg intravenous dose of NA-1 or placebo as soon as they are deemed to have met the enrollment criteria and started within 30 minutes of randomization. The randomization will be by stochastic minimization to balance baseline factors.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Placebo Comparator: Placebo
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Drug vehicle only
  • NA-1, 2.6 mg/kg Drug
    Other Names: Tat-NR2B9c
    Intervention Desc: Single intravenous infusion of NA-1 over 10 ± 1 minutes
    ARM 1: Kind: Experimental
    Label: NA-1, 2.6 mg/kg
    Description: Single intravenous infusion of NA-1 over 10 ± 1 minutes

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Modified Rankin Score (mRS) 90 Days No
Secondary mRS Shift Analysis 90 Days or the last rating No
Secondary NIHSS 90 Days or the last rating No
Secondary Barthel Index 90 Days or the last rating No
Secondary Mortality Rate 90 Days No
Secondary Functional Independence based on mRS 90 Days or the last rating No

Sponsors