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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
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


  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.
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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 
Overall Participants Analyzed 
[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


  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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