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RNS60 for Ischemic Stroke (RESCUE Trial)
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.
- Ischemic Stroke
RESCUE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowRESCUE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 2 trial • 147 Patients • NCT03456882RESCUE Trial Design
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Who is running the clinical trial?
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- The doctors think that your brain blood vessels are blocked or damaged in a way that cannot be fixed with a specific type of treatment.You recently had a severe stroke and need immediate emergency treatment.You had a seizure when your stroke happened.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).
- Group 1: RNS60 0.5 mL/kg/h
- Group 2: RNS60 1 mL/kg/h
- Group 3: Placebo 1 mL/kg/h
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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