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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-07

Study Completion Date

2023-11-08

Brief Summary

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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.

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Detailed Description

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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 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 and prior to arterial closure. Outcomes of the main trial will be evaluated throughout a 90 day observation period.

Conditions

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Stroke, Ischemic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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RNS60 0.5 mL/kg/h

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)

Group Type EXPERIMENTAL

RNS60

Intervention Type DRUG

RNS60 injection solution

RNS60 1.0 mL/kg/h

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)

Group Type EXPERIMENTAL

RNS60

Intervention Type DRUG

RNS60 injection solution

Placebo 1.0 mL/kg/h

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)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo injection solution

Interventions

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RNS60

RNS60 injection solution

Intervention Type DRUG

Placebo

Placebo injection solution

Intervention Type DRUG

Eligibility Criteria

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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 independently 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 Alberta Stroke Program Early Computerized Tomography Score (ASPECTS) 0-4.
2. 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).
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 (MI) within 6 months prior to Screening including non-Q wave MI; Diagnosis of congestive heart failure (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 magnetic resonance imaging (MRI) (Non-magnetic resonance \[MR\] 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 \> 460 ms at Screening.
18. Any other symptom that in the investigator's opinion may complicate or preclude the subject from participating in this trial.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No