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Effect of Natalizumab on Infarct Volume in Acute Ischemic Stroke (ACTION)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01955707
First Posted: October 7, 2013
Last Update Posted: July 1, 2016
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.
Information provided by (Responsible Party):
Biogen
Results First Submitted: February 4, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Acute Ischemic Stroke
Interventions: Drug: natalizumab
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo A single intravenous (IV) injection of placebo
Natalizumab 300 mg single IV injection of natalizumab

Participant Flow:   Overall Study
    Placebo   Natalizumab
STARTED   82   79 
Withdrew Prior to Dosing   0   1 
Dosed   82   78 
Received Total Volume of Study Drug   82   77 
COMPLETED   62   57 
NOT COMPLETED   20   22 
Adverse Event                1                2 
Lost to Follow-up                2                1 
Withdrawal by Subject                0                3 
Death                13                14 
Not Specified                4                2 



  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
Placebo A single IV injection of placebo
Natalizumab 300 mg single IV injection of natalizumab
Total Total of all reporting groups

Baseline Measures
   Placebo   Natalizumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 82   79   161 
Age 
[Units: Years]
Mean (Standard Deviation)
 71.6  (11.83)   70.3  (13.34)   71.0  (12.57) 
Age, Customized 
[Units: Participants]
     
</= 39 years   2   3   5 
40 to 59 years   13   11   24 
60 to 79 years   41   45   86 
>/= 80 years   26   20   46 
Gender 
[Units: Participants]
     
Female   34   38   72 
Male   48   41   89 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Infarct Volume From Baseline (Diffusion-Weighted Imaging [DWI]) to Day 5 (Fluid-Attenuated Inversion Recovery [FLAIR])   [ Time Frame: Baseline, Day 5 ]

2.  Secondary:   Change in Infarct Volume From Baseline (DWI) to 24 Hours (FLAIR)   [ Time Frame: Baseline, 24 hrs ]

3.  Secondary:   Change in Infarct Volume From Baseline (DWI) to Day 30 (FLAIR)   [ Time Frame: Baseline, Day 30 ]

4.  Secondary:   Change in Infarct Volume From 24 Hours (FLAIR) to Day 5 (FLAIR)   [ Time Frame: 24 hours, Day 5 ]

5.  Secondary:   Change in Infarct Volume From 24 Hours (FLAIR) to Day 30 (FLAIR)   [ Time Frame: 24 hours, Day 30 ]

6.  Secondary:   Change in Infarct Volume From Day 5 (FLAIR) to Day 30 (FLAIR)   [ Time Frame: Day 5, Day 30 ]

7.  Secondary:   Change in National Institute of Health Stroke Scale (NIHSS) Score From Baseline to 24 Hours, Day 5, Day 30, and Day 90   [ Time Frame: Baseline, 24 hours, Day 5, Day 30, Day 90 ]

8.  Secondary:   Modified Rankin Scale (mRS) Distribution at Day 5, Day 30, and Day 90   [ Time Frame: Day 5, Day 30, and Day 90 ]

9.  Secondary:   Barthel Index at Day 5, Day 30, and Day 90   [ Time Frame: Day 5, Day 30, and Day 90 ]

10.  Secondary:   Number of Participants Who Experience Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Up to Day 90 ± 5 days ]


  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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  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: Biogen Study Medical Director
Organization: Biogen
e-mail: clinicaltrials@biogen.com



Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01955707     History of Changes
Other Study ID Numbers: 101SK201
EUDRA CT NO: 2013‐001514‐15
First Submitted: September 30, 2013
First Posted: October 7, 2013
Results First Submitted: February 4, 2016
Results First Posted: July 1, 2016
Last Update Posted: July 1, 2016