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Safety and Efficacy of Nerinetide (NA-1) in Subjects Undergoing Endovascular Thrombectomy for Stroke (ESCAPE-NA1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02930018
Recruitment Status : Completed
First Posted : October 11, 2016
Results First Posted : December 14, 2020
Last Update Posted : October 10, 2022
Sponsor:
Collaborator:
University of Calgary
Information provided by (Responsible Party):
NoNO Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Stroke, Acute
Interventions Drug: Nerinetide (NA-1), 2.6 mg/kg
Drug: Placebo
Enrollment 1105
Recruitment Details Patients with acute ischaemic stroke who were selected to undergo EVT (endovascular thrombectomy) were enrolled. The trial was done at acute care hospitals. Patients were randomly assigned (1:1) to receive a single intravenous dose of nerinetide (NA-1) or placebo. All patients underwent endovascular thrombectomy and received alteplase in usual care when indicated.
Pre-assignment Details The trial drug was administered as soon as possible after randomisation.
Arm/Group Title Placebo Nerinetide (NA-1), 2.6 mg/kg
Hide Arm/Group Description

Drug vehicle only

Placebo: Placebo Comparator: Placebo

Single intravenous infusion of nerinetide over 10 ± 1 minutes
Period Title: Overall Study
Started 556 549
Completed 550 546
Not Completed 6 3
Reason Not Completed
Lost to Follow-up             1             1
Withdrawal by Subject             5             2
Arm/Group Title Placebo Nerinetide (NA-1), 2.6 mg/kg Total
Hide Arm/Group Description

Drug vehicle only

Placebo: Placebo Comparator: Placebo

Single intravenous infusion of nerinetide over 10 ± 1 minutes Total of all reporting groups
Overall Number of Baseline Participants 556 549 1105
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 556 participants 549 participants 1105 participants
70.0
(20 to 103)
71.0
(18 to 98)
70.0
(18 to 103)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 556 participants 549 participants 1105 participants
Female
281
  50.5%
268
  48.8%
549
  49.7%
Male
275
  49.5%
281
  51.2%
556
  50.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 556 participants 549 participants 1105 participants
Hispanic or Latino
15
   2.7%
8
   1.5%
23
   2.1%
Not Hispanic or Latino
540
  97.1%
541
  98.5%
1081
  97.8%
Unknown or Not Reported
1
   0.2%
0
   0.0%
1
   0.1%
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 556 participants 549 participants 1105 participants
American Indian or Alaska Native
2
   0.4%
2
   0.4%
4
   0.4%
Asian
52
   9.4%
55
  10.0%
107
   9.7%
Native Hawaiian or Other Pacific Islander
3
   0.5%
0
   0.0%
3
   0.3%
Black or African American
31
   5.6%
45
   8.2%
76
   6.9%
White
453
  81.5%
436
  79.4%
889
  80.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
15
   2.7%
11
   2.0%
26
   2.4%
[1]
Measure Description: Under 'Unknown or Not reported' category the number of participants for the 'Other' category is indicated
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 556 participants 549 participants 1105 participants
Canada
252
  45.3%
253
  46.1%
505
  45.7%
South Korea
20
   3.6%
22
   4.0%
42
   3.8%
Sweden
8
   1.4%
6
   1.1%
14
   1.3%
United States
203
  36.5%
211
  38.4%
414
  37.5%
Ireland
5
   0.9%
4
   0.7%
9
   0.8%
United Kingdom
1
   0.2%
1
   0.2%
2
   0.2%
Australia
25
   4.5%
18
   3.3%
43
   3.9%
Germany
42
   7.6%
34
   6.2%
76
   6.9%
Alteplase Treatment   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 556 participants 549 participants 1105 participants
Participants treated with alteplase
329
  59.2%
330
  60.1%
659
  59.6%
Participants not treated with alteplase
227
  40.8%
219
  39.9%
446
  40.4%
[1]
Measure Description: Treatment with alteplase as part of standard-of-care in addition to study drug
1.Primary Outcome
Title Number of Subjects With mRS Score of 0 to 2
Hide Description

Overall number of subjects experiencing a favorable functional outcome 90 days post-randomization, defined as 0 to 2 on the mRS.

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.

Time Frame 90 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population
Arm/Group Title Placebo Nerinetide, 2.6 mg/kg
Hide Arm/Group Description:

Drug vehicle only

Placebo: Placebo Comparator: Placebo

Single intravenous infusion of nerinetide over 10 ± 1 minutes
Overall Number of Participants Analyzed 556 549
Measure Type: Count of Participants
Unit of Measure: Participants
329
  59.2%
337
  61.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Nerinetide, 2.6 mg/kg
Comments The primary hypothesis was that administration of nerinetide (NA-1) would result in an increase in the proportion of responders. The primary analysis was a Wald test for treatment group difference in the primary outcome from a logistic regression adjusted for the 2 stratification variables (alteplase use, first declared thrombectomy device), and the 6 covariates used in the minimization. The trial was designed to have 80% power to detect an 8.7% absolute difference between groups.
Type of Statistical Test Superiority
Comments It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS (Acute Ischemic Stroke) patients with prior administration of alteplase as part of standard-of-care.
Statistical Test of Hypothesis P-Value 0.335
Comments 2 sided 0.05 significance level.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.146
Confidence Interval (2-Sided) 95%
0.869 to 1.511
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Subjects With NIHSS Score of 0 to 2
Hide Description

Number of subjects with good neurological outcome, as defined by a score of 0 to 2 on the NIHSS at Day 90 or the last rating.

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.

Time Frame 90 Days or the last rating
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Nerinetide, 2.6 mg/kg
Hide Arm/Group Description:

Drug vehicle only

Placebo: Placebo Comparator: Placebo

Single intravenous infusion of nerinetide over 10 ± 1 minutes
Overall Number of Participants Analyzed 556 549
Measure Type: Count of Participants
Unit of Measure: Participants
320
  57.6%
320
  58.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Nerinetide, 2.6 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS patients with prior administration of alteplase as part of standard-of-care.
Statistical Test of Hypothesis P-Value 0.866
Comments 2 sided 0.05 significance level.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.024
Confidence Interval (2-Sided) 95%
0.781 to 1.342
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Mortality Rate
Hide Description Mortality rate, as defined by event rate (%) for mortality over the 90-day study period
Time Frame 90 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Nerinetide, 2.6 mg/kg
Hide Arm/Group Description:

Drug vehicle only

Placebo: Placebo Comparator: Placebo

Single intravenous infusion of nerinetide over 10 ± 1 minutes
Overall Number of Participants Analyzed 556 549
Measure Type: Count of Participants
Unit of Measure: Participants
74
  13.3%
64
  11.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Nerinetide, 2.6 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS patients with prior administration of alteplase as part of standard-of-care.
Statistical Test of Hypothesis P-Value 0.199
Comments 2 sided 0.05 significance level.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.776
Confidence Interval (2-Sided) 95%
0.527 to 1.143
Estimation Comments [Not Specified]
4.Post-Hoc Outcome
Title Number of Subjects With mRS Score of 0 to 2 in the No-alteplase Sub-group
Hide Description

Overall number of subjects experiencing a favorable functional outcome 90 days post-randomization, defined as 0 to 2 on the mRS in the sub-group of participants not treated with alteplase as part of standard-of-care.

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.

Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Nerinetide, 2.6 mg/kg
Hide Arm/Group Description:

Drug vehicle only

Placebo: Placebo Comparator: Placebo

Single intravenous infusion of nerinetide over 10 ± 1 minutes
Overall Number of Participants Analyzed 227 219
Measure Type: Count of Participants
Unit of Measure: Participants
113
  49.8%
130
  59.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Nerinetide, 2.6 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.028
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.657
Confidence Interval (2-Sided) 95%
1.055 to 2.603
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Nerinetide, 2.6 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Absolute Risk Difference (%)
Estimated Value 9.6
Estimation Comments The unadjusted absolute risk difference in % between nerinetide and placebo in the no-alteplase subgroup.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Nerinetide, 2.6 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative Risk Difference (%)
Estimated Value 19.3
Estimation Comments The unadjusted relative risk difference in % between nerinetide and placebo in the no-alteplase subgroup.
5.Post-Hoc Outcome
Title Number of Subjects With NIHSS Score of 0 to 2 in the No-Alteplase Sub-group
Hide Description

Number of subjects with good neurological outcome, as defined by a score of 0 to 2 on the NIHSS at Day 90 or the last rating in the sub-group of participants not treated with alteplase as part of standard-of-care.

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.

Time Frame 90 days or last rating
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Nerinetide, 2.6 mg/kg
Hide Arm/Group Description:

Drug vehicle only

Placebo: Placebo Comparator: Placebo

Single intravenous infusion of nerinetide over 10 ± 1 minutes
Overall Number of Participants Analyzed 227 219
Measure Type: Count of Participants
Unit of Measure: Participants
113
  49.8%
129
  58.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Nerinetide, 2.6 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.088
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.482
Confidence Interval (2-Sided) 95%
0.943 to 2.329
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Nerinetide, 2.6 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Absolute Risk Difference (%)
Estimated Value 9.1
Estimation Comments The unadjusted absolute risk difference in % between nerinetide and placebo in the no-alteplase subgroup.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Nerinetide, 2.6 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative Risk Difference (%)
Estimated Value 18.3
Estimation Comments The unadjusted relative risk difference in % between nerinetide and placebo in the no-alteplase subgroup.
6.Post-Hoc Outcome
Title Mortality Rate in the No-Alteplase Sub-group
Hide Description Mortality rate, as defined by event rate (%) for mortality over the 90-day study period in the sub-group of participants not treated with alteplase as part of standard-of-care
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Nerinetide, 2.6 mg/kg
Hide Arm/Group Description:

Drug vehicle only

Placebo: Placebo Comparator: Placebo

Single intravenous infusion of nerinetide over 10 ± 1 minutes
Overall Number of Participants Analyzed 227 219
Measure Type: Count of Participants
Unit of Measure: Participants
43
  18.9%
25
  11.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Nerinetide, 2.6 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.055
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.572
Confidence Interval (2-Sided) 95%
0.323 to 1.013
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Nerinetide, 2.6 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Absolute Risk Difference (%)
Estimated Value 7.5
Estimation Comments The unadjusted absolute risk difference in % between nerinetide and placebo in the no-alteplase subgroup.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Nerinetide, 2.6 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative Risk Difference (%)
Estimated Value 39.7
Estimation Comments The unadjusted relative risk difference in % between nerinetide and placebo in the no-alteplase subgroup.
7.Post-Hoc Outcome
Title Number of Subjects With mRS Score of 0 to 2 in the Alteplase Sub-group
Hide Description

Overall proportion of subjects experiencing a favorable functional outcome 90 days post-randomization, defined as 0 to 2 on the mRS in the sub-group of participants treated with alteplase as part of standard-of-care.

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.

Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Nerinetide, 2.6 mg/kg
Hide Arm/Group Description:

Drug vehicle only

Placebo: Placebo Comparator: Placebo

Single intravenous infusion of nerinetide over 10 ± 1 minutes
Overall Number of Participants Analyzed 329 330
Measure Type: Count of Participants
Unit of Measure: Participants
216
  65.7%
207
  62.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Nerinetide, 2.6 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS patients with prior administration of alteplase as part of standard-of-care.
Statistical Test of Hypothesis P-Value 0.529
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.887
Confidence Interval (2-Sided) 95%
0.612 to 1.286
Estimation Comments [Not Specified]
8.Post-Hoc Outcome
Title Number of Subjects With NIHSS Score of 0 to 2 in the Alteplase Sub-group
Hide Description

Number of subjects with good neurological outcome, as defined by a score of 0 to 2 on the NIHSS at Day 90 or the last rating in the sub-group of participants treated with alteplase as part of standard-of-care.

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.

Time Frame 90 days or last rating
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Nerinetide, 2.6 mg/kg
Hide Arm/Group Description:

Drug vehicle only

Placebo: Placebo Comparator: Placebo

Single intravenous infusion of nerinetide over 10 ± 1 minutes
Overall Number of Participants Analyzed 329 330
Measure Type: Count of Participants
Unit of Measure: Participants
207
  62.9%
191
  57.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Nerinetide, 2.6 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS patients with prior administration of alteplase as part of standard-of-care.
Statistical Test of Hypothesis P-Value 0.181
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.782
Confidence Interval (2-Sided) 95%
0.545 to 1.121
Estimation Comments [Not Specified]
9.Post-Hoc Outcome
Title Mortality Rate in the Alteplase Sub-group
Hide Description Mortality rate, as defined by event rate (%) for mortality over the 90-day study period in the sub-group of participants treated with alteplase as part of standard-of-care
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Nerinetide, 2.6 mg/kg
Hide Arm/Group Description:

Drug vehicle only

Placebo: Placebo Comparator: Placebo

Single intravenous infusion of nerinetide over 10 ± 1 minutes
Overall Number of Participants Analyzed 329 330
Measure Type: Count of Participants
Unit of Measure: Participants
31
   9.4%
39
  11.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Nerinetide, 2.6 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS patients with prior administration of alteplase as part of standard-of-care.
Statistical Test of Hypothesis P-Value 0.869
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.050
Confidence Interval (2-Sided) 95%
0.588 to 1.874
Estimation Comments [Not Specified]
Time Frame Adverse Events occurring within 30 days of randomization and all Serious Adverse Events up to the end of study visit (Day 90 visit or death) or until the subject was deemed "lost to follow-up" were reported.
Adverse Event Reporting Description

All Adverse Events (Serious and Non-Serious) were monitored for the Safety Population, which included all subjects who received any amount of study drug (total of 1101 subjects).

Adverse Events of Special Interest (AESI) were also collected, and included any Adverse Event which occurred within 2 hours of end of drug infusion and which fall under the standardized MedDRA queries of "Angioedema", "Anaphylactic reaction", "Anaphylactic shock" and terms relating to "hypotension".

 
Arm/Group Title Placebo Nerinetide, 2.6 mg/kg
Hide Arm/Group Description

Drug vehicle only

Placebo: Placebo Comparator: Placebo

Single intravenous infusion of nerinetide over 10 ± 1 minutes
All-Cause Mortality
Placebo Nerinetide, 2.6 mg/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   74/556 (13.31%)   64/549 (11.66%) 
Hide Serious Adverse Events
Placebo Nerinetide, 2.6 mg/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   198/554 (35.74%)   181/547 (33.09%) 
Blood and lymphatic system disorders     
Anaemia * 1  4/554 (0.72%)  1/547 (0.18%) 
Thrombocytopenia * 1  0/554 (0.00%)  1/547 (0.18%) 
Cardiac disorders     
Acute coronary syndrome * 1  0/554 (0.00%)  3/547 (0.55%) 
Angina pectoris * 1  0/554 (0.00%)  1/547 (0.18%) 
Arrhythmia * 1  1/554 (0.18%)  0/547 (0.00%) 
Atrial fibrillation * 1  5/554 (0.90%)  6/547 (1.10%) 
Atrial flutter * 1  1/554 (0.18%)  1/547 (0.18%) 
Atrial tachycardia * 1  0/554 (0.00%)  1/547 (0.18%) 
Atrioventricular block * 1  0/554 (0.00%)  1/547 (0.18%) 
Bradycardia * 1  3/554 (0.54%)  0/547 (0.00%) 
Cardiac arrest * 1  2/554 (0.36%)  3/547 (0.55%) 
Cardiac failure congestive * 1  4/554 (0.72%)  9/547 (1.65%) 
Cardiac ventricular thrombosis * 1  1/554 (0.18%)  0/547 (0.00%) 
Cardiogenic shock * 1  1/554 (0.18%)  0/547 (0.00%) 
Intracardiac thrombus * 1  2/554 (0.36%)  0/547 (0.00%) 
Mitral valve stenosis * 1  0/554 (0.00%)  1/547 (0.18%) 
Myocardial infarction * 1  3/554 (0.54%)  6/547 (1.10%) 
Sinus arrest * 1  1/554 (0.18%)  0/547 (0.00%) 
Stress cardiomyopathy * 1  0/554 (0.00%)  1/547 (0.18%) 
Supraventricular tachycardia * 1  0/554 (0.00%)  1/547 (0.18%) 
Ventricular tachycardia * 1  0/554 (0.00%)  1/547 (0.18%) 
Congenital, familial and genetic disorders     
Atrial septal defect * 1  2/554 (0.36%)  1/547 (0.18%) 
Endocrine disorders     
Hyperparathyroidism * 1  0/554 (0.00%)  1/547 (0.18%) 
Eye disorders     
Retinal artery occlusion * 1  1/554 (0.18%)  3/547 (0.55%) 
Retinal detachment * 1  1/554 (0.18%)  0/547 (0.00%) 
Visual impairment * 1  1/554 (0.18%)  0/547 (0.00%) 
Gastrointestinal disorders     
Abdominal distension * 1  1/554 (0.18%)  0/547 (0.00%) 
Ascites * 1  0/554 (0.00%)  1/547 (0.18%) 
Colitis ischaemic * 1  0/554 (0.00%)  1/547 (0.18%) 
Diarrhoea * 1  0/554 (0.00%)  1/547 (0.18%) 
Dysphagia * 1  0/554 (0.00%)  2/547 (0.37%) 
Gastric ulcer haemorrhage * 1  1/554 (0.18%)  1/547 (0.18%) 
Gastrointestinal haemorrhage * 1  4/554 (0.72%)  6/547 (1.10%) 
Intestinal ischaemia * 1  1/554 (0.18%)  0/547 (0.00%) 
Melaena * 1  0/554 (0.00%)  1/547 (0.18%) 
Mouth haemorrhage * 1  0/554 (0.00%)  1/547 (0.18%) 
Oesophagitis * 1  0/554 (0.00%)  1/547 (0.18%) 
Pancreatitis * 1  1/554 (0.18%)  0/547 (0.00%) 
Peritoneal haemorrhage * 1  1/554 (0.18%)  0/547 (0.00%) 
Vomiting * 1  1/554 (0.18%)  1/547 (0.18%) 
General disorders     
Complication associated with device * 1  0/554 (0.00%)  1/547 (0.18%) 
Drug withdrawal syndrome * 1  1/554 (0.18%)  0/547 (0.00%) 
Non-cardiac chest pain * 1  2/554 (0.36%)  0/547 (0.00%) 
Pyrexia * 1  1/554 (0.18%)  0/547 (0.00%) 
Vascular stent occlusion * 1  2/554 (0.36%)  0/547 (0.00%) 
Vessel puncture site haematoma * 1  3/554 (0.54%)  1/547 (0.18%) 
Vessel puncture site haemorrhage * 1  0/554 (0.00%)  2/547 (0.37%) 
Vessel puncture site occlusion * 1  1/554 (0.18%)  0/547 (0.00%) 
Hepatobiliary disorders     
Cholangitis * 1  1/554 (0.18%)  0/547 (0.00%) 
Cholecystitis * 1  1/554 (0.18%)  1/547 (0.18%) 
Drug-induced liver injury * 1  1/554 (0.18%)  0/547 (0.00%) 
Portal vein thrombosis * 1  0/554 (0.00%)  1/547 (0.18%) 
Infections and infestations     
Bacteraemia * 1  1/554 (0.18%)  0/547 (0.00%) 
Bronchitis * 1  0/554 (0.00%)  1/547 (0.18%) 
Cardiac valve abscess * 1  0/554 (0.00%)  1/547 (0.18%) 
Cardiac valve vegetation * 1  0/554 (0.00%)  1/547 (0.18%) 
Cellulitis * 1  0/554 (0.00%)  2/547 (0.37%) 
Empyema * 1  0/554 (0.00%)  1/547 (0.18%) 
Endocarditis * 1  3/554 (0.54%)  1/547 (0.18%) 
Osteomyelitis * 1  1/554 (0.18%)  0/547 (0.00%) 
Pneumonia * 1  5/554 (0.90%)  6/547 (1.10%) 
Pneumonia bacterial * 1  1/554 (0.18%)  0/547 (0.00%) 
Sepsis * 1  6/554 (1.08%)  3/547 (0.55%) 
Septic shock * 1  2/554 (0.36%)  1/547 (0.18%) 
Stoma site abscess * 1  1/554 (0.18%)  0/547 (0.00%) 
Urinary tract infection * 1  5/554 (0.90%)  5/547 (0.91%) 
Urosepsis * 1  2/554 (0.36%)  3/547 (0.55%) 
Injury, poisoning and procedural complications     
Abdominal wound dehiscence * 1  1/554 (0.18%)  0/547 (0.00%) 
Cerebral hyperperfusion syndrome * 1  0/554 (0.00%)  1/547 (0.18%) 
Coronary artery restenosis * 1  0/554 (0.00%)  1/547 (0.18%) 
Endotracheal intubation complication * 1  1/554 (0.18%)  0/547 (0.00%) 
Facial bones fracture * 1  1/554 (0.18%)  0/547 (0.00%) 
Fall * 1  2/554 (0.36%)  0/547 (0.00%) 
Femoral neck fracture * 1  1/554 (0.18%)  0/547 (0.00%) 
Femur fracture * 1  1/554 (0.18%)  0/547 (0.00%) 
Gastrostomy tube site complication * 1  0/554 (0.00%)  1/547 (0.18%) 
Humerus fracture * 1  1/554 (0.18%)  0/547 (0.00%) 
Reocclusion * 1  1/554 (0.18%)  1/547 (0.18%) 
Rib fracture * 1  1/554 (0.18%)  0/547 (0.00%) 
Subarachnoid haemorrhage * 1  5/554 (0.90%)  1/547 (0.18%) 
Subdural haemorrhage * 1  1/554 (0.18%)  0/547 (0.00%) 
Traumatic intracranial haemorrhage * 1  2/554 (0.36%)  0/547 (0.00%) 
Vascular access site pseudoaneurysm * 1  3/554 (0.54%)  2/547 (0.37%) 
Vascular procedure complication * 1  8/554 (1.44%)  9/547 (1.65%) 
Investigations     
Hepatic enzyme abnormal * 1  1/554 (0.18%)  0/547 (0.00%) 
Troponin increased * 1  0/554 (0.00%)  1/547 (0.18%) 
White blood cell count decreased * 1  0/554 (0.00%)  1/547 (0.18%) 
Metabolism and nutrition disorders     
Dehydration * 1  1/554 (0.18%)  1/547 (0.18%) 
Hyperkalaemia * 1  1/554 (0.18%)  0/547 (0.00%) 
Musculoskeletal and connective tissue disorders     
Muscular weakness * 1  1/554 (0.18%)  0/547 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bronchial carcinoma * 1  1/554 (0.18%)  0/547 (0.00%) 
Cervix cancer metastatic * 1  0/554 (0.00%)  1/547 (0.18%) 
Gastric cancer * 1  1/554 (0.18%)  0/547 (0.00%) 
Metastasis * 1  0/554 (0.00%)  1/547 (0.18%) 
Myeloid leukaemia * 1  1/554 (0.18%)  0/547 (0.00%) 
Non-small cell lung cancer metastatic * 1  1/554 (0.18%)  0/547 (0.00%) 
Pancreatic carcinoma metastatic * 1  1/554 (0.18%)  0/547 (0.00%) 
Plasma cell myeloma * 1  0/554 (0.00%)  1/547 (0.18%) 
Prostate cancer metastatic * 1  0/554 (0.00%)  1/547 (0.18%) 
Renal cell carcinoma * 1  1/554 (0.18%)  1/547 (0.18%) 
Small intestine adenocarcinoma * 1  1/554 (0.18%)  0/547 (0.00%) 
Nervous system disorders     
Brain oedema * 1  0/554 (0.00%)  1/547 (0.18%) 
Carotid arteriosclerosis * 1  0/554 (0.00%)  1/547 (0.18%) 
Carotid artery stenosis * 1  5/554 (0.90%)  4/547 (0.73%) 
Cerebral haemorrhage * 1  1/554 (0.18%)  1/547 (0.18%) 
Dizziness * 1  1/554 (0.18%)  1/547 (0.18%) 
Encephalopathy * 1  0/554 (0.00%)  1/547 (0.18%) 
Epilepsy * 1  0/554 (0.00%)  1/547 (0.18%) 
Haemorrhage intracranial * 1  0/554 (0.00%)  1/547 (0.18%) 
Haemorrhagic stroke * 1  1/554 (0.18%)  0/547 (0.00%) 
Haemorrhagic transformation stroke * 1  11/554 (1.99%)  8/547 (1.46%) 
Ischaemic stroke * 1  20/554 (3.61%)  18/547 (3.29%) 
Lacunar stroke * 1  1/554 (0.18%)  0/547 (0.00%) 
Neurological decompensation * 1  1/554 (0.18%)  1/547 (0.18%) 
Presyncope * 1  0/554 (0.00%)  1/547 (0.18%) 
Seizure * 1  4/554 (0.72%)  1/547 (0.18%) 
Status epilepticus * 1  0/554 (0.00%)  1/547 (0.18%) 
Stroke in evolution * 1  43/554 (7.76%)  36/547 (6.58%) 
Syncope * 1  1/554 (0.18%)  1/547 (0.18%) 
Transient ischaemic attack * 1  2/554 (0.36%)  5/547 (0.91%) 
Vascular dementia * 1  1/554 (0.18%)  0/547 (0.00%) 
Psychiatric disorders     
Alcohol withdrawal syndrome * 1  1/554 (0.18%)  0/547 (0.00%) 
Delirium * 1  4/554 (0.72%)  0/547 (0.00%) 
Mental status changes * 1  1/554 (0.18%)  1/547 (0.18%) 
Post stroke depression * 1  4/554 (0.72%)  1/547 (0.18%) 
Suicidal ideation * 1  0/554 (0.00%)  1/547 (0.18%) 
Renal and urinary disorders     
Acute kidney injury * 1  3/554 (0.54%)  3/547 (0.55%) 
Azotaemia * 1  0/554 (0.00%)  1/547 (0.18%) 
Calculus urinary * 1  0/554 (0.00%)  1/547 (0.18%) 
Haematuria * 1  0/554 (0.00%)  1/547 (0.18%) 
Reproductive system and breast disorders     
Prostatomegaly * 1  1/554 (0.18%)  0/547 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Aspiration * 1  2/554 (0.36%)  0/547 (0.00%) 
Choking * 1  0/554 (0.00%)  1/547 (0.18%) 
Dyspnoea * 1  0/554 (0.00%)  1/547 (0.18%) 
Epistaxis * 1  1/554 (0.18%)  0/547 (0.00%) 
Haemothorax * 1  1/554 (0.18%)  0/547 (0.00%) 
Hypoxia * 1  1/554 (0.18%)  0/547 (0.00%) 
Obstructive airways disorder * 1  1/554 (0.18%)  0/547 (0.00%) 
Pleural effusion * 1  0/554 (0.00%)  1/547 (0.18%) 
Pneumonia aspiration * 1  12/554 (2.17%)  19/547 (3.47%) 
Pulmonary embolism * 1  6/554 (1.08%)  2/547 (0.37%) 
Pulmonary oedema * 1  5/554 (0.90%)  3/547 (0.55%) 
Respiratory distress * 1  1/554 (0.18%)  2/547 (0.37%) 
Respiratory failure * 1  8/554 (1.44%)  3/547 (0.55%) 
Skin and subcutaneous tissue disorders     
Angioedema * 1  1/554 (0.18%)  1/547 (0.18%) 
Social circumstances     
Loss of personal independence in daily activities * 1  1/554 (0.18%)  0/547 (0.00%) 
Surgical and medical procedures     
Left atrial appendage occlusion * 1  0/554 (0.00%)  1/547 (0.18%) 
Vascular disorders     
Arteriosclerosis * 1  0/554 (0.00%)  1/547 (0.18%) 
Brachiocephalic vein thrombosis * 1  1/554 (0.18%)  0/547 (0.00%) 
Deep vein thrombosis * 1  2/554 (0.36%)  1/547 (0.18%) 
Haematoma * 1  3/554 (0.54%)  1/547 (0.18%) 
Hypertension * 1  0/554 (0.00%)  1/547 (0.18%) 
Hypertensive crisis * 1  1/554 (0.18%)  0/547 (0.00%) 
Hypotension * 1  1/554 (0.18%)  7/547 (1.28%) 
Peripheral artery aneurysm * 1  0/554 (0.00%)  1/547 (0.18%) 
Peripheral artery occlusion * 1  0/554 (0.00%)  2/547 (0.37%) 
Peripheral artery thrombosis * 1  1/554 (0.18%)  2/547 (0.37%) 
Peripheral ischaemia * 1  1/554 (0.18%)  1/547 (0.18%) 
Varicose vein * 1  0/554 (0.00%)  1/547 (0.18%) 
1
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Nerinetide, 2.6 mg/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   472/554 (85.20%)   474/547 (86.65%) 
Blood and lymphatic system disorders     
Anemia * 1  42/554 (7.58%)  33/547 (6.03%) 
Cardiac disorders     
Atrial fibrillation * 1  45/554 (8.12%)  48/547 (8.78%) 
Bradycardia * 1  32/554 (5.78%)  18/547 (3.29%) 
Gastrointestinal disorders     
Nausea * 1  31/554 (5.60%)  37/547 (6.76%) 
Constipation * 1  45/554 (8.12%)  34/547 (6.22%) 
Vomiting * 1  36/554 (6.50%)  31/547 (5.67%) 
General disorders     
Pyrexia * 1  47/554 (8.48%)  40/547 (7.31%) 
Vessel puncture site hematoma * 1  28/554 (5.05%)  32/547 (5.85%) 
Infections and infestations     
Urinary tract infection * 1  68/554 (12.27%)  52/547 (9.51%) 
Injury, poisoning and procedural complications     
Vascular procedure complication * 1  54/554 (9.75%)  49/547 (8.96%) 
Metabolism and nutrition disorders     
Hypokalaemia * 1  34/554 (6.14%)  33/547 (6.03%) 
Nervous system disorders     
Headache * 1  88/554 (15.88%)  79/547 (14.44%) 
Hemorrhagic Transformation Stroke * 1  66/554 (11.91%)  60/547 (10.97%) 
Stroke In Evolution * 1  54/554 (9.75%)  48/547 (8.78%) 
Respiratory, thoracic and mediastinal disorders     
Pneumonia aspiration * 1  28/554 (5.05%)  35/547 (6.40%) 
Vascular disorders     
Hypotension * 1  54/554 (9.75%)  60/547 (10.97%) 
1
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Tymianski, MD PhD
Organization: NoNO Inc.
Phone: 4165831687
EMail: mtymianski@nonoinc.ca
Other Publications:
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Responsible Party: NoNO Inc.
ClinicalTrials.gov Identifier: NCT02930018    
Other Study ID Numbers: NA-1-007
First Submitted: October 6, 2016
First Posted: October 11, 2016
Results First Submitted: October 22, 2020
Results First Posted: December 14, 2020
Last Update Posted: October 10, 2022