Evaluating Neuroprotection in Aneurysm Coiling Therapy (ENACT)

This study has been completed.
Sponsor:
Collaborator:
Arbor Vita Corporation
Information provided by (Responsible Party):
NoNO Inc.
ClinicalTrials.gov Identifier:
NCT00728182
First received: August 1, 2008
Last updated: August 9, 2013
Last verified: August 2013
Results First Received: May 8, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Stroke
Interventions: Drug: NA-1
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between September 16, 2008 and March 30, 2011, subjects were recruited to 10 hospitals in Canada and 3 in the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
12 subjects were randomized into study but did not receive drug:5 due to do endovascular aneurysm repair, 3 due to inability to obtain a pre-procedure MRI,2 due to pre-procedure ECG showing a QTc interval > 450 ms, 1 due to a fatal aneurysm rupture before drug, and 1 due to refusal by anesthesiologist to give drug to a subject with severe COPD.

Reporting Groups
  Description
1 NA-1

20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.

NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion

2 Placebo Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion

Participant Flow:   Overall Study
    1 NA-1     2 Placebo  
STARTED     92     93  
COMPLETED     89     90  
NOT COMPLETED     3     3  
Adverse Event                 1                 0  
Lost to Follow-up                 2                 0  
Death                 0                 2  
Protocol Noncompliance                 0                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
1 NA-1

20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.

NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion

2 Placebo Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
Total Total of all reporting groups

Baseline Measures
    1 NA-1     2 Placebo     Total  
Number of Participants  
[units: participants]
  92     93     185  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     70     78     148  
>=65 years     22     15     37  
Age  
[units: years]
Mean ± Standard Deviation
  57.72  ± 10.6     56.05  ± 10.3     56.88  ± 10.5  
Gender  
[units: participants]
     
Female     64     68     132  
Male     28     25     53  
Region of Enrollment  
[units: participants]
     
United States     12     15     27  
Canada     80     78     158  



  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Volume of New FLAIR Lesions(MRI)   [ Time Frame: Enrolment, Days 2-4 ]

Measure Type Primary
Measure Title Volume of New FLAIR Lesions(MRI)
Measure Description Volume of new ischemic lesions as defined by FLAIR MRI at 12-95 hours postdose
Time Frame Enrolment, Days 2-4  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All study patients who received study drug and an analyzable MRI at 12-95 hours postdose.

Reporting Groups
  Description
1 NA-1

20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.

NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion

2 Placebo Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion

Measured Values
    1 NA-1     2 Placebo  
Number of Participants Analyzed  
[units: participants]
  91     93  
Volume of New FLAIR Lesions(MRI)  
[units: mm^3]
Mean ± Standard Deviation
  915  ± 5598     477  ± 1611  


Statistical Analysis 1 for Volume of New FLAIR Lesions(MRI)
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.445
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Comparison of the summed volume of new FLAIR lesions in the NA-1 and placebo treated groups.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Data were cubic root transformed and modelled with multiple linear regression.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



2.  Secondary:   Number of New DWI Lesions (MRI)   [ Time Frame: Enrolment, Day 2-4 ]

Measure Type Secondary
Measure Title Number of New DWI Lesions (MRI)
Measure Description Number of new ischemic lesions as defined by DWI MRI at 12-95 hours postdose.
Time Frame Enrolment, Day 2-4  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients who received study drug and an analyzable MRI at 12-95 hours postdose.

Reporting Groups
  Description
1 NA-1

20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.

NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion

2 Placebo Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion

Measured Values
    1 NA-1     2 Placebo  
Number of Participants Analyzed  
[units: participants]
  91     93  
Number of New DWI Lesions (MRI)  
[units: Lesions]
Mean ± Standard Deviation
  4.1  ± 6.8     7.3  ± 12.6  


Statistical Analysis 1 for Number of New DWI Lesions (MRI)
Groups [1] All groups
Method [2] Generalized linear model
P Value [3] 0.018
Adjusted Incidence Rate Ratio [4] 0.53
95% Confidence Interval ( 0.38 to 0.74 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Comparison of the total number of new ischemic lesions on DWI for NA-1 versus placebo treated groups.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  With log link and negative bnomial distribution.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



3.  Secondary:   Number of New FLAIR Lesions (MRI)   [ Time Frame: Enrolment, Days 2-4 ]

Measure Type Secondary
Measure Title Number of New FLAIR Lesions (MRI)
Measure Description Number of new ischemic lesions as defined by FLAIR MRI at 12-95 hours postdose.
Time Frame Enrolment, Days 2-4  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients who received study drug and an analyzable MRI scan at 12-95 hours postdose.

Reporting Groups
  Description
1 NA-1

20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.

NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion

2 Placebo Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion

Measured Values
    1 NA-1     2 Placebo  
Number of Participants Analyzed  
[units: participants]
  91     93  
Number of New FLAIR Lesions (MRI)  
[units: Lesions]
Mean ± Standard Deviation
  3.0  ± 4.4     4.8  ± 7.7  


Statistical Analysis 1 for Number of New FLAIR Lesions (MRI)
Groups [1] All groups
Method [2] Generalized linear model
P Value [3] 0.048
Adjusted Incidence Rate Ratio [4] 0.59
95% Confidence Interval ( 0.42 to 0.83 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Comparison of the total number of new FLAIR lesions in the NA-1 versus placebo treated groups.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  With log link and negative binomial distribution.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



4.  Secondary:   Volume of New DWI Lesions (MRI)   [ Time Frame: Enrolment, Days 2-4 ]

Measure Type Secondary
Measure Title Volume of New DWI Lesions (MRI)
Measure Description Volume of new DWI lesions as defined by MRI at 12-95 hours postdose.
Time Frame Enrolment, Days 2-4  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients who received study drug and an analyzable MRI at 12-95 hours postdose.

Reporting Groups
  Description
1 NA-1

20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.

NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion

2 Placebo Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion

Measured Values
    1 NA-1     2 Placebo  
Number of Participants Analyzed  
[units: participants]
  91     93  
Volume of New DWI Lesions (MRI)  
[units: mm^3]
Mean ± Standard Deviation
  966  ± 5266     645  ± 1382  


Statistical Analysis 1 for Volume of New DWI Lesions (MRI)
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.306
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Comparison of the summed volume of new ischemic lesions on DWI.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Data were cubic root transformed and modelled with multiple linear regresion.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



5.  Secondary:   National Institutes of Health Stroke Scale (NIHSS).   [ Time Frame: Enrolment, Day 30 ]

Measure Type Secondary
Measure Title National Institutes of Health Stroke Scale (NIHSS).
Measure Description The NIHSS is a standardized neurological method to measure disability and recovery after stroke. Scores range from 0 to 42, with higher scores indicating increasing severity. Scores were dichotomized into 0-1 (good outcome) versus 2 or above. The number of participants scoring 0-1 on the NIHSS at Day 30 was compared for both groups.
Time Frame Enrolment, Day 30  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients who received study drug and outcome assessment at Day 30.

Reporting Groups
  Description
1 NA-1

20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.

NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion

2 Placebo Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion

Measured Values
    1 NA-1     2 Placebo  
Number of Participants Analyzed  
[units: participants]
  92     93  
National Institutes of Health Stroke Scale (NIHSS).  
[units: No. of participants with NIHSS 0-1]
  86     83  


Statistical Analysis 1 for National Institutes of Health Stroke Scale (NIHSS).
Groups [1] All groups
Method [2] Chi-squared
P Value [3] 0.43
Relative Risk [4] 1.0
95% Confidence Interval ( 0.9 to 1.1 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Number of patients obtaining a score on the NIHSS of 0-1 at Day 30.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



6.  Secondary:   Modified Rankin Scale (mRS).   [ Time Frame: Enrolment, Day 30 ]

Measure Type Secondary
Measure Title Modified Rankin Scale (mRS).
Measure Description The mRS is a measure of global disability that has been widely applied for evaluating recovery from stroke. Scores range from 0 to 6, with higher scores indicating greater disability. A score of 0 indicates no residual symptoms; 1 = no significant disability/able to carry out all usual activities, despite some symptoms; 2 = slight disability; 3 = moderate disability; 4 = moderately severe disability; 5 = severe disability; 6 = death. The number of participants scoring 0-2 on the mRS at Day 30 was compared in both treatment groups.
Time Frame Enrolment, Day 30  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients who received study drug and an outcome assessment at Day 30

Reporting Groups
  Description
1 NA-1

20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.

NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion

2 Placebo Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion

Measured Values
    1 NA-1     2 Placebo  
Number of Participants Analyzed  
[units: participants]
  92     93  
Modified Rankin Scale (mRS).  
[units: No. of participants with mRS 0-2]
  86     87  


Statistical Analysis 1 for Modified Rankin Scale (mRS).
Groups [1] All groups
Method [2] Chi-squared
P Value [3] 1.00
Relative Risk [4] 1.0
95% Confidence Interval ( 0.9 to 1.1 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Comparison of the number of patients with mRS scores of 0-2 at Day 30 for NA-1 and placebo treated groups.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



7.  Other Pre-specified:   Volume of New FLAIR Lesions (MRI) - Ruptured Aneurysm Subjects   [ Time Frame: Enrolment, Days 2-4 ]

Measure Type Other Pre-specified
Measure Title Volume of New FLAIR Lesions (MRI) - Ruptured Aneurysm Subjects
Measure Description Volume of new ischemic lesions as defined by FLAIR MRI at 12-95 hours postdose (pre-specified subgroup analysis)
Time Frame Enrolment, Days 2-4  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who entered the study with a ruptured aneurysm, who received study drug and an analyzable MRI at 12-95 hours postdose.

Reporting Groups
  Description
1 NA-1 - Subjects With Ruptured Aneurysms

20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.

NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion

2 Placebo - Subjects With Ruptured Aneurysms Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion

Measured Values
    1 NA-1 - Subjects With Ruptured Aneurysms     2 Placebo - Subjects With Ruptured Aneurysms  
Number of Participants Analyzed  
[units: participants]
  18     19  
Volume of New FLAIR Lesions (MRI) - Ruptured Aneurysm Subjects  
[units: mm^3]
Mean ± Standard Deviation
  205  ± 495     1575  ± 3229  


Statistical Analysis 1 for Volume of New FLAIR Lesions (MRI) - Ruptured Aneurysm Subjects
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.023
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



8.  Other Pre-specified:   Number of New DWI Lesions (MRI) - Ruptured Aneuryms Subjects   [ Time Frame: Enrolment, Day 2-4 ]

Measure Type Other Pre-specified
Measure Title Number of New DWI Lesions (MRI) - Ruptured Aneuryms Subjects
Measure Description Number of new ischemic lesions as defined by DWI MRI at 12-95 hours postdose(pre-specified subgroup analysis)
Time Frame Enrolment, Day 2-4  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who entered the study with a ruptured aneurysm, who received study drug and an analyzable MRI at 12-95 hours postdose.

Reporting Groups
  Description
1 NA-1 - Subjects With Ruptured Aneurysms

20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.

NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion

2 Placebo - Subjects With Ruptured Aneurysms Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion

Measured Values
    1 NA-1 - Subjects With Ruptured Aneurysms     2 Placebo - Subjects With Ruptured Aneurysms  
Number of Participants Analyzed  
[units: participants]
  18     19  
Number of New DWI Lesions (MRI) - Ruptured Aneuryms Subjects  
[units: Lesions]
Mean ± Standard Deviation
  3.4  ± 5.9     9.47  ± 11.6  


Statistical Analysis 1 for Number of New DWI Lesions (MRI) - Ruptured Aneuryms Subjects
Groups [1] All groups
Method [2] Adjusted Incidence Rate Ratio
P Value [3] 0.027
Adjusted Incidence Rate Ratio [4] 0.36
95% Confidence Interval ( 0.17 to 0.73 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



9.  Other Pre-specified:   Number of New FLAIR Lesions (MRI) - Ruptured Aneurysm Subjects   [ Time Frame: Enrolment, Day 2-4 ]

Measure Type Other Pre-specified
Measure Title Number of New FLAIR Lesions (MRI) - Ruptured Aneurysm Subjects
Measure Description Number of new ischemic lesions as defined by FLAIR MRI at 12-95 hours postdose(pre-specified subgroup analysis)
Time Frame Enrolment, Day 2-4  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who entered the study with a ruptured aneurysm, who received study drug and an analyzable MRI at 12-95 hours postdose.

Reporting Groups
  Description
1 NA-1 - Subjects With Ruptured Aneurysms

20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.

NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion

2 Placebo - Subjects With Ruptured Aneurysms Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion

Measured Values
    1 NA-1 - Subjects With Ruptured Aneurysms     2 Placebo - Subjects With Ruptured Aneurysms  
Number of Participants Analyzed  
[units: participants]
  18     19  
Number of New FLAIR Lesions (MRI) - Ruptured Aneurysm Subjects  
[units: Lesions]
Mean ± Standard Deviation
  2.4  ± 4.7     6.58  ± 7.5  


Statistical Analysis 1 for Number of New FLAIR Lesions (MRI) - Ruptured Aneurysm Subjects
Groups [1] All groups
Method [2] Generalized linear model
P Value [3] 0.046
Adjusted Incidence Rate Ratio [4] 0.36
95% Confidence Interval ( 0.17 to 0.75 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



10.  Other Pre-specified:   Volume of New DWI Lesions (MRI) - Ruptured Aneurysm Subjects   [ Time Frame: Enrolment, Day 2-4 ]

Measure Type Other Pre-specified
Measure Title Volume of New DWI Lesions (MRI) - Ruptured Aneurysm Subjects
Measure Description Volume of new DWI lesions as defined by MRI at 12-95 hours postdose(pre-specified subgroup analysis)
Time Frame Enrolment, Day 2-4  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who entered the study with a ruptured aneurysm, who received study drug and an analyzable MRI at 12-95 hours postdose.

Reporting Groups
  Description
1 NA-1 - Subjects With Ruptured Aneurysms

20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.

NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion

2 Placebo - Subjects With Ruptured Aneurysms Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion

Measured Values
    1 NA-1 - Subjects With Ruptured Aneurysms     2 Placebo - Subjects With Ruptured Aneurysms  
Number of Participants Analyzed  
[units: participants]
  18     19  
Volume of New DWI Lesions (MRI) - Ruptured Aneurysm Subjects  
[units: mm^3]
Mean ± Standard Deviation
  277  ± 528     1373  ± 2267  


Statistical Analysis 1 for Volume of New DWI Lesions (MRI) - Ruptured Aneurysm Subjects
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.015
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



11.  Other Pre-specified:   National Institutes of Health Stroke Scale (NIHSS) - Ruptured Aneurysm Subjects   [ Time Frame: Enrolment, Day 30 ]

Measure Type Other Pre-specified
Measure Title National Institutes of Health Stroke Scale (NIHSS) - Ruptured Aneurysm Subjects
Measure Description The NIHSS is a standardized neurological method to measure disability and recovery after stroke. Scores range from 0 to 42, with higher scores indicating increasing severity. Scores were dichotomized into 0-1 (good outcome) versus 2 or above. The number of participants scoring 0-1 on the NIHSS at Day 30 was compared for participants with ruptured aneurysms in both treatment groups(pre-specified subgroup analysis).
Time Frame Enrolment, Day 30  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who entered the study with a ruptured aneurysm, who received study drug and outcome assessment at Day 30.

Reporting Groups
  Description
1 NA-1 - Subjects With Ruptured Aneurysms

20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.

NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion

2 Placebo - Subjects With Ruptured Aneurysms Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion

Measured Values
    1 NA-1 - Subjects With Ruptured Aneurysms     2 Placebo - Subjects With Ruptured Aneurysms  
Number of Participants Analyzed  
[units: participants]
  18     19  
National Institutes of Health Stroke Scale (NIHSS) - Ruptured Aneurysm Subjects  
[units: No. of participants with NIHSS 0-1]
  18     13  


Statistical Analysis 1 for National Institutes of Health Stroke Scale (NIHSS) - Ruptured Aneurysm Subjects
Groups [1] All groups
Method [2] Chi-squared
P Value [3] 0.02
Relative Risk [4] 1.5
95% Confidence Interval ( 1.1 to 2.0 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



12.  Other Pre-specified:   Modified Rankin Scale (mRS)- Ruptured Aneurysm Subjects   [ Time Frame: Enrolment, Day 30 ]

Measure Type Other Pre-specified
Measure Title Modified Rankin Scale (mRS)- Ruptured Aneurysm Subjects
Measure Description The mRS is a measure of global disability that has been widely applied for evaluating recovery from stroke. Scores range from 0 to 6, with higher scores indicating greater disability. A score of 0 indicates no residual symptoms; 1 = no significant disability/able to carry out all usual activities, despite some symptoms; 2 = slight disability; 3 = moderate disability; 4 = moderately severe disability; 5 = severe disability; 6 = death. The number of participants scoring 0-2 on the mRS at Day 30 with ruptured aneurysms was compared in both treatment groups(pre-specified subgroup analysis).
Time Frame Enrolment, Day 30  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
1 NA-1 - Subjects With Ruptured Aneurysms

20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.

NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion

2 Placebo - Subjects With Ruptured Aneurysms Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion

Measured Values
    1 NA-1 - Subjects With Ruptured Aneurysms     2 Placebo - Subjects With Ruptured Aneurysms  
Number of Participants Analyzed  
[units: participants]
  18     19  
Modified Rankin Scale (mRS)- Ruptured Aneurysm Subjects  
[units: No. of participants with mRS 0-2]
  17     14  


Statistical Analysis 1 for Modified Rankin Scale (mRS)- Ruptured Aneurysm Subjects
Groups [1] All groups
Method [2] Chi-squared
P Value [3] 0.18
Relative Risk [4] 1.3
95% Confidence Interval ( 0.95 to 1.7 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
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[2] Other relevant method information, such as adjustments or degrees of freedom:
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[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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[4] Other relevant estimation information:
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  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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