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

NCT04693715 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 06.5.1.H1
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 7

Brief 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 65 mL/h), 1.0 mL/kg/h RNS60 (up to a maximum of 130 mL/h), or 1.0 mL/kg/h (up to a maximum of 130 mL/h) placebo (normal saline) starting within 30 minutes of consent after confirmation of candidacy for endovascular thrombectomy.

Conditions

Stroke, Ischemic

Keywords

Endovascular Thrombectomy

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Serious Adverse Events (SAEs)

  An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or resulted in a congenital anomaly/birth defect. An SAE could also be an important medical event that may not have resulted in death, was life-threatening, or required hospitalization, but jeopardized the participant and required medical or surgical intervention to prevent one of the outcomes listed above. Treatment-emergent SAEs were defined as SAEs that started after the start of study drug infusion and are reported here.

  From start of study drug administration up to Day 90

• Mortality: Proportion of Participants Alive at Day 90

  Day 90

Secondary Outcomes (6)

• Number of Participants With Non-disability Based on Modified Rankin Scale (mRS ) Score at Day 90

  Day 90

• Change From Baseline in Infarct Volume of Stroke at 48 Hours

  Baseline, 48 hours

• National Institutes of Health Stroke Scale (NIHSS) at 24 Hours

  24 hours

• Proportion of Participants With Worsening of Stroke

  Up to Day 90

• Percentage of Participants With Barthel Index (BI) Score ≥95 at Day 90

  Day 90

Study Arms (3)

RNS60 0.5 mL/kg/h

EXPERIMENTAL

RNS60 0.5 mL/kg/h infusion for 48h (up to a maximum of 65 mL/h) starting within 30 min of randomization (but prior to arterial access closure)

Drug: RNS60

RNS60 1.0 mL/kg/h

EXPERIMENTAL

RNS60 1.0 mL/kg/h infusion for 48h (up to a maximum of 130 mL/h) starting within 30 min of randomization (but prior to arterial access closure)

Drug: RNS60

Placebo 1.0 mL/kg/h

PLACEBO COMPARATOR

Placebo (normal saline) 1.0 mL/kg/h infusion for 48h (up to a maximum of 130 mL/h) starting within 30 min of randomization (but prior to arterial access closure)

Drug: Placebo

Interventions

RNS60 DRUG

RNS60 injection solution

RNS60 0.5 mL/kg/h; RNS60 1.0 mL/kg/h

Placebo DRUG

Placebo injection solution

Placebo 1.0 mL/kg/h

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute ischemic stroke (AIS) selected for emergency endovascular treatment.
• Age 18 years or older.
• Onset (last-known-well) time to randomization time within 24 hours.
• Disabling stroke defined as a baseline National Institutes of Health Stroke Score (NIHSS)
• NIHSS \> 5 for internal carotid artery (ICA) and M1-middle cerebral artery (MCA) occlusion or
• NIHSS \> 10 for M2-MCA occlusion.
• 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.
• Pre-stroke (24 hours prior to stroke onset) historical modified Rankin Scale (mRS) ≤2. Patient must be living independently without requiring nursing care.
• Qualifying imaging performed less than 2 hours prior to randomization.
• Consent process completed as per applicable laws and regulation and the IRB requirements.

You may not qualify if:

• Evidence of a large core of established infarction defined as Alberta Stroke Program Early Computerized Tomography Score (ASPECTS) 0-4.
• Evidence of absence of collateral circulation on qualifying imaging (collateral score of 0 or 1 if multiphase computed tomography angiography (mCTA) is used, or absence of adequate ischemic penumbra in the judgment of the Investigator if computed tomographic perfusion (CTP) is used).
• Any evidence of intracranial hemorrhage or mass lesion on the qualifying imaging.
• Planned use of an endovascular device not having approval or clearance by the relevant regulatory authority.
• Endovascular thrombectomy procedure is completed as defined by the presence of arterial access closure.
• 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.
• Estimated or known weight \> 130 kg (287 lbs).
• Known pregnant/lactating female.
• Myocardial infarction (MI) within 6 months prior to Screening including non-Q wave MI; Diagnosis of congestive heart failure (CHF) with either:
• current clinical signs and symptoms of ventricular dysfunction (e.g., edema, shortness of breath),
• CHF medication adjustment within the prior 30 days or
• 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.
• Known renal impairment defined as requiring renal replacement therapy (hemo- or peritoneal dialysis).
• Inability to have magnetic resonance imaging (MRI) (Non-magnetic resonance \[MR\] compatible implants or any other foreseeable reason, including claustrophobia)
• Severe or fatal comorbid illness that will prevent improvement or follow up.

Sponsors & Collaborators

• Revalesio Corporation: lead

Study Sites (7)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Chattanooga Center for Neurologic Research

Chattanooga, Tennessee, 37404, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Ghosh S, Dubow JS, Sutherland J, Smith W, Chiu D, Clark WM, Favilla CG, Ansari SA, Kalmes A, Mock J, Cook DJ, Madsen TE, Jayaraman M, Moldovan K, Torabi R, Liebeskind DS, Fisher M, McTaggart RA. Randomized, Proof-of-Concept Trial (RESCUE) of RNS60 as an Adjunct Therapy in Acute Ischemic Stroke. Stroke. 2025 Sep;56(9):2386-2397. doi: 10.1161/STROKEAHA.125.051179. Epub 2025 Jul 17.

  PMID: 40671649 RESULT

MeSH Terms

Conditions

Ischemic Stroke

Interventions

RNS60

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Clinical Operations
• Organization: Revalesio Corporation

contact@revalesio.com

253-922-2600

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2020
• First Posted: January 5, 2021
• Study Start: July 7, 2021
• Primary Completion: November 8, 2023
• Study Completion: November 8, 2023
• Last Updated: January 12, 2026
• Results First Posted: January 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)