Trial · NCT04462536

Efficacy and Safety of Nerinetide in Participants With Acute Ischemic Stroke Undergoing Endovascular Thrombectomy Excluding Thrombolysis

NCT04462536, Phase 3, Completed, NoNO Inc.; results first posted 2025-06-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Nerinetide in Participants With Acute Ischemic Stroke Undergoing Endovascular Thrombectomy Excluding Thrombolysis. Trials, record NCT04462536. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04462536

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety of Nerinetide in Participants With Acute Ischemic Stroke Undergoing Endovascular Thrombectomy Excluding Thrombolysis
NCT number: NCT04462536
Status: Completed
Phases: Phase 3
Enrollment: 850 participants, actual
Lead sponsor: NoNO Inc.
Conditions: Stroke, Acute
Interventions: Placebo, Nerinetide
First posted: 2020-07-08
Last updated: 2025-06-22
Results first posted: 2025-06-22

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Independent Functioning on the Modified Rankin Scale (mRS), as Defined by a Score of 0-2	90 days	The modified Rankin Scale (mRS) is a valid and reliable clinician-reported measure of global disability that has been widely applied for evaluating recovery from stroke. It is a scale used to measure functional recovery (the degree of disability or dependence in daily activities) of people who have suffered a stroke. mRS scores range from 0 (best outcome) to 6 (worst outcome), with 0 indicating no residual symptoms; 5 indicating bedbound, requiring constant care; and 6 indicating death.
Secondary	Mortality Rate, as Defined by Event Rate (Percent) for Mortality Over the 90-day Study Period.	90 days	The estimand of mortality rate was the adjusted unconditional population difference in the number of deaths observed divided by the number of participants observed over the 90-day study period (mortality proportions) between treatment conditions (nerinetide vs. placebo) in the target patient population at Day 90. Deaths occurring over the Day 90 period were considered as non-responses.
Secondary	Number of Participants Exhibiting a Worsening of Their Index Stroke.	90 days	Worsening of stroke is defined as (A) progression, or hemorrhagic transformation of the index stroke, as documented by medical imaging 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 or (B) results in death from the index stroke.
Secondary	Number of Participants With Good Neurological Outcome, as Defined by a Score of 0-2 on the NIHSS at Day 90 Post Randomization.	90 days	The National Institutes of Health Stroke Scale (NIHSS) is a standardized neurological examination score that is a valid and reliable measure of disability and recovery after acute stroke. Scores range from 0 to 42, with higher scores indicating increasing severity.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Independent Functioning on the Modified Rankin Scale (mRS), as Defined by a Score of 0-2	90 days	ITT Population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Mortality Rate, as Defined by Event Rate (Percent) for Mortality Over the 90-day Study Period.	90 days	ITT Population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Exhibiting a Worsening of Their Index Stroke.	90 days	ITT Population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Good Neurological Outcome, as Defined by a Score of 0-2 on the NIHSS at Day 90 Post Randomization.	90 days		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Number of Participants With Independent Functioning on the Modified Rankin Scale (mRS), as Defined by a Score of 0-2	Placebo	181	Participants
Number of Participants With Independent Functioning on the Modified Rankin Scale (mRS), as Defined by a Score of 0-2	Nerinetide	206	Participants
Mortality Rate, as Defined by Event Rate (Percent) for Mortality Over the 90-day Study Period.	Placebo	70	Participants
Mortality Rate, as Defined by Event Rate (Percent) for Mortality Over the 90-day Study Period.	Nerinetide	87	Participants
Number of Participants Exhibiting a Worsening of Their Index Stroke.	Placebo	68	Participants
Number of Participants Exhibiting a Worsening of Their Index Stroke.	Nerinetide	76	Participants
Number of Participants With Good Neurological Outcome, as Defined by a Score of 0-2 on the NIHSS at Day 90 Post Randomization.	Placebo	251	Participants
Number of Participants With Good Neurological Outcome, as Defined by a Score of 0-2 on the NIHSS at Day 90 Post Randomization.	Nerinetide	268	Participants

Source ClinicalTrials.gov

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	396
Overall Study	STARTED	Nerinetide	454
Overall Study	Received Study Medication	Placebo	393
Overall Study	Received Study Medication	Nerinetide	451
Overall Study	COMPLETED	Placebo	391
Overall Study	COMPLETED	Nerinetide	441
Overall Study	NOT COMPLETED	Placebo	5
Overall Study	NOT COMPLETED	Nerinetide	13

Source ClinicalTrials.gov

Adverse events64

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Urinary Tract infection	Infections and infestations	Placebo	46	393
other	Urinary Tract infection	Infections and infestations	Nerinetide	52	451
other	Hypotension	Vascular disorders	Placebo	36	393
other	Hypotension	Vascular disorders	Nerinetide	54	451
other	Haemorrhagic transformation stroke	Nervous system disorders	Placebo	39	393
other	Haemorrhagic transformation stroke	Nervous system disorders	Nerinetide	50	451
other	Headache	Nervous system disorders	Placebo	26	393
other	Headache	Nervous system disorders	Nerinetide	52	451
other	Hypokalaemia	Metabolism and nutrition disorders	Placebo	34	393
other	Hypokalaemia	Metabolism and nutrition disorders	Nerinetide	47	451

1 to 10 of 64Source ClinicalTrials.gov

See all 64 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	70	396
Total, all-cause mortality	Nerinetide	87	454
Total, other adverse events	Placebo	329	393
Total, other adverse events	Nerinetide	393	451
Total, serious adverse events	Placebo	148	393
Total, serious adverse events	Nerinetide	182	451

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
39955119	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons6

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Nerinetide vs Placebo: Number of Participants With Good Neurological Outcome, as Defined by a Score of 0-2 on the NIHSS at Day 90 Post Randomization.	Trial comparisons
Nerinetide vs Placebo: Mortality Rate, as Defined by Event Rate (Percent) for Mortality Over the 90-day Study Period.	Trial comparisons
Nerinetide vs Placebo: Number of Participants With Independent Functioning on the Modified Rankin Scale (mRS), as Defined by a Score of 0-2	Trial comparisons
Nerinetide vs Placebo: deaths from any cause	Trial comparisons
Nerinetide vs Placebo: Number of Participants Exhibiting a Worsening of Their Index Stroke.	Trial comparisons
Nerinetide vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04462536

GET https://conductscience.org/api/trials/v1/NCT04462536/events?page=2

API reference For AI assistants