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Efficacy and Safety of Nerinetide in Participants With Acute Ischemic Stroke Undergoing Endovascular Thrombectomy Excluding Thrombolysis

NCT04462536 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 850

Last updated 2025-06-22

Study results available
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Summary

The primary purpose of this study is to determine if a single dose of nerinetide can reduce global disability in people who have had a stroke and are selected for endovascular therapy without the use of a tissue plasminogen activator (alteplase, tenecteplase, or equivalent).

Conditions

  • Stroke, Acute

Interventions

DRUG

Placebo

Vehicle only

DRUG

Nerinetide

Single intravenous infusion of nerinetide 2.6 mg/kg (up to a maximum dose of 270 mg) over 10 ± 1 minutes

Sponsors & Collaborators

  • University of Calgary

    collaborator OTHER

  • NoNO Inc.

    lead INDUSTRY

Principal Investigators

  • Michael D. Hill, MD MSc · Study Principal Investigator, University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-06
Primary Completion
2023-08-31
Completion
2023-08-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Germany
  • Italy
  • Netherlands
  • Norway
  • Singapore
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04462536 on ClinicalTrials.gov