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

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

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

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

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

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

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

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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events
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Frequency Threshold
Threshold above which other adverse events are reported   5%  

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

Other Adverse Events
    1 NA-1     2 Placebo  
Total, other (not including serious) adverse events      
# participants affected / at risk     83/92     85/93  
Eye disorders      
Eye pain † 1    
# participants affected / at risk     1/92 (1.09%)     5/93 (5.38%)  
# events     1     5  
Gastrointestinal disorders      
Nausea † 1    
# participants affected / at risk     33/92 (35.87%)     27/93 (29.03%)  
# events     33     28  
Vomiting † 1    
# participants affected / at risk     12/92 (13.04%)     8/93 (8.60%)  
# events     12     8  
Constipation † 1    
# participants affected / at risk     4/92 (4.35%)     7/93 (7.53%)  
# events     4     7  
General disorders      
Fatigue † 1    
# participants affected / at risk     1/92 (1.09%)     7/93 (7.53%)  
# events     1     7  
Puncture site pain † 1    
# participants affected / at risk     5/92 (5.43%)     5/93 (5.38%)  
# events     5     5  
Infections and infestations      
Urinary tract infection † 1    
# participants affected / at risk     7/92 (7.61%)     3/93 (3.23%)  
# events     7     3  
Injury, poisoning and procedural complications      
Procedural pain † 1    
# participants affected / at risk     2/92 (2.17%)     10/93 (10.75%)  
# events     2     10  
Metabolism and nutrition disorders      
Hypocalcaemia † 1    
# participants affected / at risk     4/92 (4.35%)     5/93 (5.38%)  
# events     4     5  
Hypokalaemia † 1    
# participants affected / at risk     6/92 (6.52%)     4/93 (4.30%)  
# events     6     4  
Musculoskeletal and connective tissue disorders      
Back pain † 1    
# participants affected / at risk     6/92 (6.52%)     7/93 (7.53%)  
# events     6     7  
Nervous system disorders      
Headache † 1    
# participants affected / at risk     42/92 (45.65%)     37/93 (39.78%)  
# events     47     39  
Dizziness † 1    
# participants affected / at risk     6/92 (6.52%)     2/93 (2.15%)  
# events     6     3  
Hypoaesthesia † 1    
# participants affected / at risk     4/92 (4.35%)     5/93 (5.38%)  
# events     4     5  
Psychiatric disorders      
Anxiety † 1    
# participants affected / at risk     3/92 (3.26%)     7/93 (7.53%)  
# events     3     8  
Renal and urinary disorders      
Haematuria † 1    
# participants affected / at risk     5/92 (5.43%)     4/93 (4.30%)  
# events     5     4  
Skin and subcutaneous tissue disorders      
Alopecia † 1    
# participants affected / at risk     5/92 (5.43%)     2/93 (2.15%)  
# events     5     2  
Vascular disorders      
Hypotension † 1    
# participants affected / at risk     9/92 (9.78%)     6/93 (6.45%)  
# events     10     6  
Hypertension    
# participants affected / at risk     4/92 (4.35%)     7/93 (7.53%)  
# events     4     7  
Haematoma † 1    
# participants affected / at risk     6/92 (6.52%)     7/93 (7.53%)  
# events     6     7  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA



  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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