Trial Outcomes & Findings for Safety of RNS60 in Large Vessel Occlusion Stroke Patients Undergoing Endovascular Thrombectomy (NCT NCT04693715)

Last Updated: 2026-01-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

83 participants

Primary outcome timeframe

From start of study drug administration up to Day 90

Results posted on

2026-01-12

Participant Flow

This study was conducted at 5 sites in the United States.

Participants experiencing a large vessel occlusion (LVO) acute ischemic stroke (AIS) who were selected for endovascular thrombectomy (EVT) were randomized in a 1:1:1 ratio to one of three arms in the study. Participants were given a 48-hour infusion of either 0.5 milliliter/kilogram/hour (mL/kg/h) RNS60, 1.0 mL/kg/h RNS60, or 1.0 mL/kg/h placebo (normal saline).

Participant milestones

Participant milestones
Measure	RNS60 1.0 mL/kg/h Participants received RNS60 1.0 mL/kg/h infusion for 48 hours (up to a maximum of 130 mL/h) starting within 30 min of randomization (but prior to arterial access closure).	RNS60 0.5 mL/kg/h Participants received RNS60 0.5 mL/kg/h infusion for 48 hours (up to a maximum of 65 mL/h) starting within 30 min of randomization (but prior to arterial access closure).	Placebo 1.0 mL/kg/h Participants received placebo (normal saline) 1.0 mL/kg/h infusion for 48 hours (up to a maximum of 130 mL/h) starting within 30 min of randomization (but prior to arterial access closure).
Overall Study STARTED	24	31	28
Overall Study Intent-to-treat (ITT) Population	24	30	28
Overall Study Safety Population	24	30	28
Overall Study COMPLETED	22	25	21
Overall Study NOT COMPLETED	2	6	7

Reasons for withdrawal

Reasons for withdrawal
Measure	RNS60 1.0 mL/kg/h Participants received RNS60 1.0 mL/kg/h infusion for 48 hours (up to a maximum of 130 mL/h) starting within 30 min of randomization (but prior to arterial access closure).	RNS60 0.5 mL/kg/h Participants received RNS60 0.5 mL/kg/h infusion for 48 hours (up to a maximum of 65 mL/h) starting within 30 min of randomization (but prior to arterial access closure).	Placebo 1.0 mL/kg/h Participants received placebo (normal saline) 1.0 mL/kg/h infusion for 48 hours (up to a maximum of 130 mL/h) starting within 30 min of randomization (but prior to arterial access closure).
Overall Study Adverse Events Leading to Death	2	2	4
Overall Study Lost to Follow-up	0	2	2
Overall Study Physician Decision	0	1	0
Overall Study Withdrawal by Legal Authorized Representative	0	1	0
Overall Study Withdrawal by Subject	0	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo 1.0 mL/kg/h n=28 Participants Participants received placebo (normal saline) 1.0 mL/kg/h infusion for 48 hours (up to a maximum of 130 mL/h) starting within 30 min of randomization (but prior to arterial access closure).	Total n=82 Participants Total of all reporting groups	RNS60 1.0 mL/kg/h n=24 Participants Participants received RNS60 1.0 mL/kg/h infusion for 48 hours (up to a maximum of 130 mL/h) starting within 30 min of randomization (but prior to arterial access closure).	RNS60 0.5 mL/kg/h n=30 Participants Participants received RNS60 0.5 mL/kg/h infusion for 48 hours (up to a maximum of 65 mL/h) starting within 30 min of randomization (but prior to arterial access closure).
Age, Continuous	66.0 years STANDARD_DEVIATION 12.50 • n=8 Participants	67.2 years STANDARD_DEVIATION 11.88 • n=24 Participants	67.8 years STANDARD_DEVIATION 10.65 • n=210 Participants	68.0 years STANDARD_DEVIATION 12.51 • n=19 Participants
Sex: Female, Male Female	11 Participants n=8 Participants	31 Participants n=24 Participants	7 Participants n=210 Participants	13 Participants n=19 Participants
Sex: Female, Male Male	17 Participants n=8 Participants	51 Participants n=24 Participants	17 Participants n=210 Participants	17 Participants n=19 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=8 Participants	5 Participants n=24 Participants	2 Participants n=210 Participants	2 Participants n=19 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=8 Participants	77 Participants n=24 Participants	22 Participants n=210 Participants	28 Participants n=19 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=210 Participants	0 Participants n=19 Participants
Race/Ethnicity, Customized White	24 Participants n=8 Participants	68 Participants n=24 Participants	21 Participants n=210 Participants	23 Participants n=19 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=8 Participants	9 Participants n=24 Participants	2 Participants n=210 Participants	6 Participants n=19 Participants
Race/Ethnicity, Customized Asian	2 Participants n=8 Participants	4 Participants n=24 Participants	1 Participants n=210 Participants	1 Participants n=19 Participants
Race/Ethnicity, Customized Other	1 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=210 Participants	0 Participants n=19 Participants

PRIMARY outcome

Timeframe: From start of study drug administration up to Day 90

Population: Safety Population: All randomized participants who received any volume of study drug based on the actual treatment received.

Outcome measures

Outcome measures
Measure	RNS60 0.5 mL/kg/h n=30 Participants Participants received RNS60 0.5 mL/kg/h infusion for 48 hours (up to a maximum of 65 mL/h) starting within 30 min of randomization (but prior to arterial access closure).	Placebo 1.0 mL/kg/h n=28 Participants Participants received placebo (normal saline) 1.0 mL/kg/h infusion for 48 hours (up to a maximum of 130 mL/h) starting within 30 min of randomization (but prior to arterial access closure).	RNS60 1.0 mL/kg/h n=24 Participants Participants received RNS60 1.0 mL/kg/h infusion for 48 hours (up to a maximum of 130 mL/h) starting within 30 min of randomization (but prior to arterial access closure).
Number of Participants With Serious Adverse Events (SAEs)	10 Participants	8 Participants	6 Participants

PRIMARY outcome

Timeframe: Day 90

Population: ITT Population: All randomized participants who received study drug regardless of treatment actually received.

Outcome measures

Outcome measures
Measure	RNS60 0.5 mL/kg/h n=30 Participants Participants received RNS60 0.5 mL/kg/h infusion for 48 hours (up to a maximum of 65 mL/h) starting within 30 min of randomization (but prior to arterial access closure).	Placebo 1.0 mL/kg/h n=28 Participants Participants received placebo (normal saline) 1.0 mL/kg/h infusion for 48 hours (up to a maximum of 130 mL/h) starting within 30 min of randomization (but prior to arterial access closure).	RNS60 1.0 mL/kg/h n=24 Participants Participants received RNS60 1.0 mL/kg/h infusion for 48 hours (up to a maximum of 130 mL/h) starting within 30 min of randomization (but prior to arterial access closure).
Mortality: Proportion of Participants Alive at Day 90	0.933 proportion of participants	0.857 proportion of participants	0.917 proportion of participants

SECONDARY outcome

Timeframe: Day 90

Population: ITT Population: All randomized participants who received study drug regardless of treatment actually received.

The mRS is a clinician-reported outcome measure for participants who have suffered a stroke. It measures functional recovery as the degree of disability or dependence in daily activities in a 6-point disability scale with possible scores ranging from 0 to 5: 0-no symptoms at all; 1-no significant disability despite symptoms; able to carry out all usual duties and activities; 2-slight disability: unable to carry out all previous activities but able to look after own affairs without assistance; 3-moderate disability: requiring some help, but able to walk without assistance; 4-moderately severe disability: unable to walk without assistance and unable to attend to own bodily needs without assistance; 5-severe disability; bedridden, incontinent, requiring constant nursing care and attention. A score of 6 is used for participants who expire (death). Non-disability was defined as a score ranging from 0 to 2. Disability was defined as a score ranging from 3-6.

Outcome measures

Outcome measures
Measure	RNS60 0.5 mL/kg/h n=30 Participants Participants received RNS60 0.5 mL/kg/h infusion for 48 hours (up to a maximum of 65 mL/h) starting within 30 min of randomization (but prior to arterial access closure).	Placebo 1.0 mL/kg/h n=28 Participants Participants received placebo (normal saline) 1.0 mL/kg/h infusion for 48 hours (up to a maximum of 130 mL/h) starting within 30 min of randomization (but prior to arterial access closure).	RNS60 1.0 mL/kg/h n=24 Participants Participants received RNS60 1.0 mL/kg/h infusion for 48 hours (up to a maximum of 130 mL/h) starting within 30 min of randomization (but prior to arterial access closure).
Number of Participants With Non-disability Based on Modified Rankin Scale (mRS ) Score at Day 90	13 Participants	13 Participants	15 Participants

SECONDARY outcome

Timeframe: Baseline, 48 hours

Population: ITT Population: All randomized participants who received study drug regardless of treatment actually received. Number of participants analyzed is the number of participants with data available at the specific time point.

Infarct progression/regression was measured by Magnetic Resonance Imaging (MRI) of the brain. The mean change from post-EVT baseline in the volume of injured tissue was calculated at 48 hours.

Outcome measures

Outcome measures
Measure	RNS60 0.5 mL/kg/h n=29 Participants Participants received RNS60 0.5 mL/kg/h infusion for 48 hours (up to a maximum of 65 mL/h) starting within 30 min of randomization (but prior to arterial access closure).	Placebo 1.0 mL/kg/h n=28 Participants Participants received placebo (normal saline) 1.0 mL/kg/h infusion for 48 hours (up to a maximum of 130 mL/h) starting within 30 min of randomization (but prior to arterial access closure).	RNS60 1.0 mL/kg/h n=24 Participants Participants received RNS60 1.0 mL/kg/h infusion for 48 hours (up to a maximum of 130 mL/h) starting within 30 min of randomization (but prior to arterial access closure).
Change From Baseline in Infarct Volume of Stroke at 48 Hours Baseline	37.9 mL Standard Deviation 41.82 • Interval 0.0 to 175.6	49.0 mL Standard Deviation 55.93 • Interval 1.2 to 213.9	43.6 mL Standard Deviation 40.26 • Interval 0.9 to 137.8
Change From Baseline in Infarct Volume of Stroke at 48 Hours Change From Baseline at 48 Hours	27.1 mL Standard Deviation 30.00 • Interval -1.6 to 84.8	40.6 mL Standard Deviation 42.20 • Interval 1.1 to 172.6	21.4 mL Standard Deviation 23.16 • Interval 0.2 to 86.6

SECONDARY outcome

Timeframe: 24 hours

Population: ITT Population: All randomized participants who received study drug regardless of treatment actually received. The number of participants analyzed is the number of participants with data available at the 24 hour time point.

The NIHSS is a standardized neurological examination scale that is a measure of disability and recovery after acute stroke. The NIHSS assessment is a standardized 15-item impairment scale intended to evaluate neurologic outcome and degrees of recovery for subjects with stroke. The scale assesses levels of consciousness, extraocular movements, visual fields, facial muscle function, extremity strength, sensory function, coordination (ataxia), language (aphasia), speech (dysarthria), and hemi-inattention (neglect). The NIHSS was scored by those trained in the use of this scale. Each item was scored in ranges 0-2, 0-3, or 0-4. A score of 0 indicates normal performance. Total scores on the NIHSS ranged from 0-42, with higher values reflecting increasing severity. Stroke severity was further stratified in the following way: \> 25: Very severe; 15-24: Severe; 5-14: Mild to moderately severe; \< 5: Mild.

Outcome measures

Outcome measures
Measure	RNS60 0.5 mL/kg/h n=29 Participants Participants received RNS60 0.5 mL/kg/h infusion for 48 hours (up to a maximum of 65 mL/h) starting within 30 min of randomization (but prior to arterial access closure).	Placebo 1.0 mL/kg/h n=27 Participants Participants received placebo (normal saline) 1.0 mL/kg/h infusion for 48 hours (up to a maximum of 130 mL/h) starting within 30 min of randomization (but prior to arterial access closure).	RNS60 1.0 mL/kg/h n=24 Participants Participants received RNS60 1.0 mL/kg/h infusion for 48 hours (up to a maximum of 130 mL/h) starting within 30 min of randomization (but prior to arterial access closure).
National Institutes of Health Stroke Scale (NIHSS) at 24 Hours	10.4 score on a scale Standard Deviation 7.67	10.9 score on a scale Standard Deviation 7.88	8.3 score on a scale Standard Deviation 6.77

SECONDARY outcome

Timeframe: Up to Day 90

Population: ITT Population: All randomized participants who received study drug regardless of treatment actually received.

Worsening of stroke was defined as progression, or hemorrhagic transformation of the index stroke, as documented by brain imaging, which is (a) life-threatening requiring intervention and/or (b) results in increased disability as gauged by a ≥ 4-point increase from lowest NIHSS pre-decline and/or (c) results in death. Proportion of participants with worsening of stroke was calculated as number of participants with worsening of stroke divided by the total number of participants observed over the 90-day period in each arm.

Outcome measures

Outcome measures
Measure	RNS60 0.5 mL/kg/h n=30 Participants Participants received RNS60 0.5 mL/kg/h infusion for 48 hours (up to a maximum of 65 mL/h) starting within 30 min of randomization (but prior to arterial access closure).	Placebo 1.0 mL/kg/h n=28 Participants Participants received placebo (normal saline) 1.0 mL/kg/h infusion for 48 hours (up to a maximum of 130 mL/h) starting within 30 min of randomization (but prior to arterial access closure).	RNS60 1.0 mL/kg/h n=24 Participants Participants received RNS60 1.0 mL/kg/h infusion for 48 hours (up to a maximum of 130 mL/h) starting within 30 min of randomization (but prior to arterial access closure).
Proportion of Participants With Worsening of Stroke	0.400 proportion of participants	0.286 proportion of participants	0.208 proportion of participants

SECONDARY outcome

Timeframe: Day 90

The BI is an index of functional independence. Its values range from 0 to 100, with higher scores indicating greater independence. Score range in BI items: Feeding 0-10; Bathing 0-5; Grooming 0-5; Dressing 0-10; Bowels 0-10; Bladder 0-10; Toilet use 0-10; Transfers (bed to chair and back) 0-15; Mobility (on level surfaces) 0-15; Stairs 0-10. Item scores vary in increments of 5 points. Functional independence at Day 90 was evaluated. Participants having a score ≥95 on the BI Score were deemed to have achieved functional independence, whereas those scoring \<95 at Day 90 were deemed to have failed to achieve functional independence.

Outcome measures

Outcome measures
Measure	RNS60 0.5 mL/kg/h n=30 Participants Participants received RNS60 0.5 mL/kg/h infusion for 48 hours (up to a maximum of 65 mL/h) starting within 30 min of randomization (but prior to arterial access closure).	Placebo 1.0 mL/kg/h n=28 Participants Participants received placebo (normal saline) 1.0 mL/kg/h infusion for 48 hours (up to a maximum of 130 mL/h) starting within 30 min of randomization (but prior to arterial access closure).	RNS60 1.0 mL/kg/h n=24 Participants Participants received RNS60 1.0 mL/kg/h infusion for 48 hours (up to a maximum of 130 mL/h) starting within 30 min of randomization (but prior to arterial access closure).
Percentage of Participants With Barthel Index (BI) Score ≥95 at Day 90	40.0 percentage of participants	42.9 percentage of participants	70.8 percentage of participants

SECONDARY outcome

Timeframe: Day 90

EQ-5D-5L is a generic instrument for measuring health-related quality of life. It consists of a 5-item questionnaire, which was interviewer administered by study staff. The 5-item questionnaire comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and each dimension has 5 response levels (1-no problems, 2-slight problems, 3-moderate problems, 4-severe problems, 5-unable to/extreme problems). The health state is then summarized to be a single number, EQ-5D-5L Index score, by applying a country-specific standard value set. EQ-5D-5L Index score for the United States ranges from -0.59 to 1, where 1 indicates a better health condition.

Outcome measures

Outcome measures
Measure	RNS60 0.5 mL/kg/h n=23 Participants Participants received RNS60 0.5 mL/kg/h infusion for 48 hours (up to a maximum of 65 mL/h) starting within 30 min of randomization (but prior to arterial access closure).	Placebo 1.0 mL/kg/h n=19 Participants Participants received placebo (normal saline) 1.0 mL/kg/h infusion for 48 hours (up to a maximum of 130 mL/h) starting within 30 min of randomization (but prior to arterial access closure).	RNS60 1.0 mL/kg/h n=21 Participants Participants received RNS60 1.0 mL/kg/h infusion for 48 hours (up to a maximum of 130 mL/h) starting within 30 min of randomization (but prior to arterial access closure).
Health-related Quality of Life as Measured by 5-Level EuroQoL 5D Index (EQ-5D-5L) at Day 90	0.60 score on a scale Standard Deviation 0.33	0.66 score on a scale Standard Deviation 0.28	0.77 score on a scale Standard Deviation 0.29

Adverse Events

RNS60 1.0 mL/kg/h

Serious events: 6 serious events

Other events: 21 other events

Deaths: 2 deaths

RNS60 0.5 mL/kg/h

Serious events: 10 serious events

Other events: 28 other events

Deaths: 2 deaths

Placebo 1.0 mL/kg/h

Serious events: 8 serious events

Other events: 27 other events

Deaths: 4 deaths

Serious adverse events

Other adverse events

Additional Information

Clinical Operations

Revalesio Corporation

Phone: 253-922-2600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigator can publish only a) after first publication of the data by the sponsor or b) 18 months after the study has been completed, whichever comes first. The sponsor can review results communications 30 days prior to public release and can delay these for no more than 60 days from the date that the request is given to the investigator. The sponsor cannot require changes to the communication, other than to remove sponsor confidential information, and cannot unilaterally extend the delay.
Publication restrictions are in place

Restriction type: OTHER