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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
History of Changes
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 ]
  Show Outcome Measure 1

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

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

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

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

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

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

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

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

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

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

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


  Serious Adverse Events
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  Other Adverse Events
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  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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Roberta Anderson, Vice President of Clinical Development
Organization: NoNO Inc.
phone: 613 833-1020
e-mail: randerson@nonoinc.ca


Publications of Results:


Responsible Party: NoNO Inc.
ClinicalTrials.gov Identifier: NCT00728182     History of Changes
Other Study ID Numbers: 3302 (NA-1-002)
Study First Received: August 1, 2008
Results First Received: May 8, 2013
Last Updated: August 9, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada