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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT01955707
First received: September 30, 2013
Last updated: May 24, 2016
Last verified: May 2016
Results First Received: February 4, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, 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  
Number of Participants  
[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
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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
Study First Received: September 30, 2013
Results First Received: February 4, 2016
Last Updated: May 24, 2016
Health Authority: Spain: Spanish Agency of Medicines
Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration