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Neuroprotective Agent

Nerinetide for Stroke (ESCAPE-NEXT Trial)

Phase 3

Waitlist Available

Led By Michael D. Hill M.D., MSc

Research Sponsored by NoNO Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

ESCAPE-NEXT Trial Summary

This trial will test if nerinetide can help reduce disability for people who have had a stroke and are selected for endovascular therapy, without the use of a tissue plasminogen activator.

Eligible Conditions

Stroke

ESCAPE-NEXT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with independent functioning on the modified Rankin Scale (mRS), as defined by a score of 0-2

Secondary outcome measures

A shift of one or more categories to reduced functional dependence analyzed across the whole distribution of outcomes on the mRS at Day 90 post randomization.

Mortality rate, as defined by event rate (percent) for mortality over the 90-day study period.

Number of participants exhibiting a worsening of their index stroke.

+1 more

Other outcome measures

Health-related quality of life, as measured by the EQ-5D-5L at Day 90.

Number of participants with excellent functional outcome, as defined by a score of 0-1 on the mRS at Day 90 post randomization.

Number of participants with functional independence in activities of daily living, as defined by a score of ≥ 95 on the Barthel Index (BI) at Day 90 post randomization.

+2 more

ESCAPE-NEXT Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NerinetideExperimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

Vehicle only

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nerinetide

2020

Completed Phase 3

~850

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

NoNO Inc.Lead Sponsor

5 Previous Clinical Trials

1,866 Total Patients Enrolled

2 Trials studying Stroke

1,290 Patients Enrolled for Stroke

University of CalgaryOTHER

792 Previous Clinical Trials

868,304 Total Patients Enrolled

33 Trials studying Stroke

39,485 Patients Enrolled for Stroke

Michael D. Hill M.D., MScPrincipal InvestigatorStudy Principal Investigator, University of Calgary

Media Library

Nerinetide (Neuroprotective Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04462536 — Phase 3

Stroke Research Study Groups: Placebo, Nerinetide

Stroke Clinical Trial 2023: Nerinetide Highlights & Side Effects. Trial Name: NCT04462536 — Phase 3

Nerinetide (Neuroprotective Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04462536 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many places are coordinating this clinical trial?

"Currently, this study is being conducted at 32 different hospitals including Grady Memorial Hospital in Atlanta, Swedish Medical Center in Englewood, and St. Joseph's Hospital & Medical Center in Phoenix among other locations."

Answered by AI

How many people are included as test subjects in this experiment?

"In order for this research to be conducted, a total of 1020 individuals that meet the eligibility requirements must participate. The sponsor, NoNO Inc., will run the trial from various locations, such as Grady Memorial Hospital in Atlanta, Georgia and Swedish Medical Center in Englewood, Colorado."

Answered by AI

What are the potential side effects of Nerinetide?

"Nerinetide, which is in Phase 3 of clinical trials, received a safety score of 3. This is due to the presence of some data supporting efficacy as well as multiple rounds of data supporting safety."

Answered by AI

Are new enrollees still being accepted for this clinical trial?

"That is correct, the clinicaltrials.gov website says that this research project is still looking for subjects. The first posting was on December 6th 2020 and there have been updates as recently as April 12th 2022. They are hoping to enroll 1020 individuals at 32 different hospitals or clinics."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "Efficacy and Safety of Nerinetide in Participants With Acute Ischemic Stroke Undergoing Endovascular Thrombectomy Excluding Thrombolysis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04462536.