Safety of RNS60 in Large Vessel Occlusion Stroke Patients Undergoing Endovascular Thrombectomy

Stroke, Ischemic Clinical Trial

— RESCUE  

Official title:

RESCUE: A Randomized, Blinded, Placebo-controlled, Parallel Group Design to Determine the Safety of RNS60 in Large Vessel Occlusion Stroke Patients Undergoing Endovascular Thrombectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04693715
• Other study ID #: 06.5.1.H1
• Status: Completed
• Phase: Phase 2
• Start date: July 7, 2021
• Est. completion date: November 8, 2023

Study information

• Verified date: August 2023
• Source: Revalesio Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Phase II, randomized, blinded, placebo-controlled, parallel group study with patients experiencing a large vessel occlusion acute ischemic stroke who are selected for endovascular revascularization. Participants will be given a 48 h infusion of either 0.5 mL/kg/h RNS60 (up to a maximum of 60 mL/h), 1 mL/kg/h RNS60 (up to a maximum of 120 mL/h), or 1 mL/kg/h (up to a maximum of 120 mL/h) placebo (normal saline) starting within 30 minutes of consent after confirmation of candidacy for endovascular thrombectomy.

Description:

This study is a Phase II, randomized, blinded, placebo-controlled, parallel group design. Participants experiencing a large vessel occlusion acute ischemic stroke who are selected for endovascular revascularization will be given a 48 h infusion of either 0.5 mL/kg/h RNS60 (up to a maximum of 60 mL/h), 1 mL/kg/h RNS60 (up to a maximum of 120 mL/h), or 1 mL/kg/h (up to a maximum of 120 mL/h) placebo (normal saline) starting within 30 minutes of consent after confirmation of candidacy for endovascular thrombectomy and prior to arterial closure. Outcomes of the main trial will be evaluated throughout a 90 day observation period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: November 8, 2023
• Est. primary completion date: November 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Acute ischemic stroke (AIS) selected for emergency endovascular treatment.

2. Age 18 years or older.

3. Onset (last-known-well) time to randomization time within 24 hours.

4. Disabling stroke defined as a baseline National Institutes of Health Stroke Score (NIHSS)

1. NIHSS > 5 for internal carotid artery (ICA) and M1-middle cerebral artery (MCA) occlusion or

2. NIHSS > 10 for M2-MCA occlusion.

5. Confirmed symptomatic intracranial occlusion at one or more of the following locations: Intracranial carotid I/T/L, M1 or M2 segment MCA. Tandem extracranial carotid and intracranial occlusions are permitted.

6. Pre-stroke (24 hours prior to stroke onset) historical modified Rankin Scale (mRS) =2. Patient must be living without requiring nursing care.

7. Qualifying imaging performed less than 2 hours prior to randomization.

8. Consent process completed as per applicable laws and regulation and the IRB requirements.

Exclusion Criteria:

1. Evidence of a large core of established infarction defined as ASPECTS 0-4.

2. Evidence of absence of collateral circulation on qualifying imaging (Collateral score of 0 or 1).

3. Any evidence of intracranial hemorrhage or mass lesion on the qualifying imaging.

4. Planned use of an endovascular device not having approval or clearance by the relevant regulatory authority.

5. Endovascular thrombectomy procedure is completed as defined by the presence of arterial access closure.

6. Clinical history, past imaging or clinical judgment suggesting that the intracranial occlusion is chronic or there is suspected intracranial dissection such that there is a predicted lack of success with endovascular intervention.

7. Estimated or known weight > 130 kg (287 lbs).

8. Known pregnant/lactating female.

9. Myocardial infarction within 6 months prior to Screening including non-Q wave MI; Diagnosis of CHF with either:

1. current clinical signs and symptoms of ventricular dysfunction (e.g., edema, shortness of breath),

2. CHF medication adjustment within the prior 30 days or

3. ejection fraction (if report available) of 30% or less measured in the 6 months prior to Screening; as either medically documented or reported by patient or another person considered by the Investigator to be reasonably reliable.

10. Known renal impairment defined as requiring renal replacement therapy (hemo- or peritoneal dialysis).

11. Inability to have MRI imaging (Non- MR compatible implants or any other foreseeable reason, including claustrophobia)

12. Severe or fatal comorbid illness that will prevent improvement or follow up.

13. Inability to complete follow-up treatment to Day 90.

14. Participation in another clinical trial investigating a drug, medical device, or a medical procedure in the 30 days preceding trial inclusion and throughout the duration of the trial.

15. Reported known seizure at time of stroke onset.

16. Ischemic stroke within previous 30 days.

17. Patients in normal sinus rhythm with a known QTcF > 450 ms at Screening.

18. Any other symptom that in the investigator's opinion may complicate or preclude the subject from participating in this trial.

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke
• Stroke, Ischemic

Intervention

Drug:
• RNS60
RNS60 injection solution
• Placebo
Placebo injection solution

Locations

Country	Name	City	State
United States	Chattanooga Center for Neurologic Research	Chattanooga	Tennessee
United States	Northwestern University	Chicago	Illinois
United States	Houston Methodist Hospital	Houston	Texas
United States	The Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Revalesio Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Infarct progression/regression	Infarct size measured by MRI brain imaging	90 days
Other	Quality of life score	Health-related quality of life as measured by the 5-level EuroQoL 5D index (EQ-5D-5L)	90 days
Primary	Proportion of subjects with serious adverse events		90 days
Primary	Mortality: proportion of participants alive		90 days
Secondary	Mean mRS score	mRS = Modified Rankin Scale	90 days
Secondary	Reduction in mortality rate	Lower event rate on the Kaplan Meier survival curve	90 days
Secondary	Mean NIHSS score	NIHSS = National Institutes of Health Stroke Scale	90 days
Secondary	Proportion of participants with a worsening of stroke	Worsening of stroke defined as progression, or hemorrhagic transformation, of the index stroke as documented by medical imaging and that is (a) life-threatening requiring intervention and/or (b) results in increased disability as gauged by a =4 point increase from lowest NIHSS during hospitalization and/or (c) results in death	90 days
Secondary	Mean BI	Mean Barthel Index (BI) at Day 90 relative to pre-stroke BI	90 days