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RNS60 for Ischemic Stroke (RESCUE Trial)

Phase 2
Waitlist Available
Research Sponsored by Revalesio Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Acute ischemic stroke (AIS) selected for emergency endovascular treatment
NIHSS > 5 for internal carotid artery (ICA) and M1-middle cerebral artery (MCA) occlusion or NIHSS > 10 for M2-MCA occlusion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

RESCUE Trial Summary

This trial is studying whether a 48-hour infusion of RNS60 can improve outcomes in patients with large vessel occlusion acute ischemic stroke who are selected for endovascular revascularization.

Eligible Conditions
  • Ischemic Stroke

RESCUE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You recently had a severe stroke and need immediate emergency treatment.
Select...
Your stroke severity score is higher than 5 for blockages in the main artery to the brain (ICA and M1-MCA), or higher than 10 for blockages in smaller arteries (M2-MCA).

RESCUE Trial Timeline

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
Mortality: proportion of participants alive
Proportion of subjects with serious adverse events
Secondary outcome measures
Mean BI
Mean NIHSS score
Mean mRS score
+2 more
Other outcome measures
Infarct progression/regression
Quality of life score

Side effects data

From 2021 Phase 2 trial • 147 Patients • NCT03456882
15%
HEADACHE
15%
FLU
10%
TEMPERATURE
8%
FRACTURE
7%
LUMBOSCIATALGIA
7%
FALL
5%
MALAISE
5%
HYPERTENSION
5%
NAUSEA
5%
DERMATITIS
5%
NASAL CONGESTION
3%
ABDOMINAL COLIC
1%
CHOLECYSTITIS
1%
BRONCHOPNEUMONIA
1%
JOINT PAIN
1%
HEMATOMA
1%
BRONCHIAL OBSTRUCTION
1%
PANCREATITIS
1%
PNEUMONIA
1%
CHILLS
1%
DIARREHA
100%
80%
60%
40%
20%
0%
Study treatment Arm
NORMAL SALINE
RNS60

RESCUE Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: RNS60 1 mL/kg/hExperimental Treatment1 Intervention
RNS60 1 mL/kg/h infusion for 48h (up to a maximum of 120 mL/kg) starting within 30 min of randomization (but prior to arterial access closure)
Group II: RNS60 0.5 mL/kg/hExperimental Treatment1 Intervention
RNS60 0.5 mL/kg/h infusion for 48h (up to a maximum of 60 mL/kg) starting within 30 min of randomization (but prior to arterial access closure)
Group III: Placebo 1 mL/kg/hPlacebo Group1 Intervention
Placebo (normal saline) 1 mL/kg/h infusion for 48h (up to a maximum of 120 mL/kg) starting within 30 min of randomization (but prior to arterial access closure)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RNS60
2011
Completed Phase 2
~460

Find a Location

Who is running the clinical trial?

Revalesio CorporationLead Sponsor
12 Previous Clinical Trials
361 Total Patients Enrolled

Media Library

Endovascular Thrombectomy (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04693715 — Phase 2
Ischemic Stroke Research Study Groups: RNS60 0.5 mL/kg/h, RNS60 1 mL/kg/h, Placebo 1 mL/kg/h
Ischemic Stroke Clinical Trial 2023: Endovascular Thrombectomy Highlights & Side Effects. Trial Name: NCT04693715 — Phase 2
Endovascular Thrombectomy (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04693715 — Phase 2

Frequently Asked Questions

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

Is this study limited to North America or are there other continents with test sites as well?

"For this study, 7 sites are enrolling patients. Some notable locations include Chattanooga Center for Neurologic Research, Northwestern University in Chicago, and Houston Methodist Hospital in Houston."

Answered by AI

What are the main goals of this experiment?

"The aim of this clinical trial, as it will be measured over the course of 3 months, is to evaluate serious adverse events. Additionally, researchers will secondary outcomes including proportion of patients with a worsening stroke, mean Barthel Index at Day 90 relative to pre-stroke BI, and modified Rankin Scale score."

Answered by AI

When might the FDA approve RNS60?

"While there is some clinical data indicating that RNS60 is safe, none of it supports the efficacy of the medication. Therefore, it received a score of 2."

Answered by AI

How many people will this research project be testing?

"The clinical trial requires 100 eligible patients in order to commence. Revalesio Corporation, the sponsor of the study, will be running it out of Chattanooga Center for Neurologic Research and Northwestern University."

Answered by AI

Are new patients being enrolled in this trial at this time?

"That is correct. The notice on clinicaltrials.gov says that the trial is still recruiting patients. 7/7/2021 was when the posting originally went up, and it has been updated as recently as 11/9/2022. They are looking for 100 individuals to fill out the trial across 7 sites."

Answered by AI
~22 spots leftby Mar 2025