Effect of Natalizumab on Infarct Volume in Acute Ischemic Stroke
ACTION
A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study to Evaluate the Safety and Efficacy of Intravenous Natalizumab (BG00002) on Reducing Infarct Volume in Acute Ischemic Stroke
2 other identifiers
interventional
161
3 countries
50
Brief Summary
The primary objective of the study is to determine whether one 300 mg dose of intravenous (IV) natalizumab reduces change in infarct volume from Baseline to Day 5 on magnetic resonance imaging (MRI) in participants with acute ischemic stroke when given at ≤6 hours or at \>6 to ≤9 hours from when they were last known normal (LKN). The secondary objectives of this study in this study population are as follows: to assess the efficacy of natalizumab on change in infarct volume from Baseline to Day 30; to assess efficacy of natalizumab on change in infarct volume from 24 hours to Day 5 and Day 30; to assess the efficacy of natalizumab on clinical measures of stroke outcome; to assess the safety of natalizumab in participants with acute ischemic stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2014
Shorter than P25 for phase_2
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2013
CompletedFirst Posted
Study publicly available on registry
October 7, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedResults Posted
Study results publicly available
July 1, 2016
CompletedJuly 1, 2016
May 1, 2016
1.1 years
September 30, 2013
February 4, 2016
May 24, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Infarct Volume From Baseline (Diffusion-Weighted Imaging [DWI]) to Day 5 (Fluid-Attenuated Inversion Recovery [FLAIR])
Relative growth of infarct volume from Baseline (relative growth = FLAIR at Day 5 divided by Baseline DWI). Geometric mean calculated as the exponential of the mean log relative growth.
Baseline, Day 5
Secondary Outcomes (9)
Change in Infarct Volume From Baseline (DWI) to 24 Hours (FLAIR)
Baseline, 24 hrs
Change in Infarct Volume From Baseline (DWI) to Day 30 (FLAIR)
Baseline, Day 30
Change in Infarct Volume From 24 Hours (FLAIR) to Day 5 (FLAIR)
24 hours, Day 5
Change in Infarct Volume From 24 Hours (FLAIR) to Day 30 (FLAIR)
24 hours, Day 30
Change in Infarct Volume From Day 5 (FLAIR) to Day 30 (FLAIR)
Day 5, Day 30
- +4 more secondary outcomes
Study Arms (2)
natalizumab
EXPERIMENTAL300 mg single intravenous (IV) injection
Placebo
PLACEBO COMPARATORA single IV dose of placebo
Interventions
Administered as described in the treatment arm
Eligibility Criteria
You may qualify if:
- Diagnosis of acute ischemic stroke.
- Score of ≥6 points on the National Institute of Health Stroke Scale (NIHSS) at Screening.
- At least 1 acute infarct with largest diameter of more than 2 cm on Baseline brain diffusion-weighted imaging (DWI).
- Participants who have received reperfusion therapy may be eligible to participate but must meet all eligibility criteria and perform the Baseline study magnetic resonance imaging (MRI) after reperfusion therapy has been completed.
- Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for at least 3 months after their dose of study treatment.
You may not qualify if:
- Presence of any intracranial hemorrhage (ICH) on head computed tomography (CT) or non-petechial ICH on screening MRI.
- Stroke isolated to the brainstem.
- Presence of coma
- Expected to die OR unable to be evaluated within 5 days.
- Hypotension requiring the use of intravenous (IV) vasopressor support or systolic blood pressure \<90 mmHg at the time of randomization.
- Known prior treatment with natalizumab.
- Immunocompromised subjects, as determined by the Investigator.
- History of progressive multifocal leukoencephalopathy (PML).
- Contraindications to MRI, e.g., implanted pacemaker or other contraindicated implanted metal devices, history of or risk for side effects from gadolinium, or claustrophobia that cannot be medically managed.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (50)
Research Site
San Diego, California, United States
Research Site
Gainesville, Florida, United States
Research Site
Kansas City, Kansas, 66160, United States
Research Site
Boston, Massachusetts, 02114, United States
Research Site
Golden Valley, Minnesota, 55422, United States
Research Site
St Louis, Missouri, 63110, United States
Research Site
Lake Success, New York, United States
Research Site
New York, New York, 10032, United States
Research Site
Durham, North Carolina, 27710, United States
Research Site
Akron, Ohio, United States
Research Site
Dayton, Ohio, 45409, United States
Research Site
Toledo, Ohio, United States
Research Site
Portland, Oregon, United States
Research Site
Tualatin, Oregon, 97062, United States
Research Site
Philadelphia, Pennsylvania, 19104, United States
Research Site
Nashville, Tennessee, United States
Research Site
Dallas, Texas, United States
Research Site
Charlottesville, Virginia, United States
Research Site
Milwaukee, Wisconsin, United States
Research Site
Altenburg, 04600, Germany
Research Site
Bad Neustadt an der Saale, 97616, Germany
Research Site
Berlin, 12203, Germany
Research Site
Bonn, Germany
Research Site
Düsseldorf, 40225, Germany
Research Site
Erlangen, 91054, Germany
Research Site
Frankfurt, 60528, Germany
Research Site
Hanover, Germany
Research Site
Heidelberg, 69120, Germany
Research Site
Idar-Oberstein, 55743, Germany
Research Site
Leipzig, 04103, Germany
Research Site
Ludwigshafen, 67063, Germany
Research Site
Ludwigshafen, Germany
Research Site
Mannheim, Germany
Research Site
Trier, 54290, Germany
Research Site
Tübingen, 72076, Germany
Research Site
Ulm, Germany
Research Site
Albacete, 02006, Spain
Research Site
Badalona, 8916, Spain
Research Site
Barakaldo, Spain
Research Site
Barcelona, 8003, Spain
Research Site
Barcelona, 8035, Spain
Research Site
Barcelona, 8036, Spain
Research Site
Girona, 17007, Spain
Research Site
Madrid, 28034, Spain
Research Site
Pamplona, 31008, Spain
Research Site
Santiago de Compostela, 15706, Spain
Research Site
Seville, 41009, Spain
Research Site
Seville, 41013, Spain
Research Site
Valencia, Spain
Research Site
Valladolid, 47005, Spain
Related Publications (1)
Elkins J, Veltkamp R, Montaner J, Johnston SC, Singhal AB, Becker K, Lansberg MG, Tang W, Chang I, Muralidharan K, Gheuens S, Mehta L, Elkind MSV. Safety and efficacy of natalizumab in patients with acute ischaemic stroke (ACTION): a randomised, placebo-controlled, double-blind phase 2 trial. Lancet Neurol. 2017 Mar;16(3):217-226. doi: 10.1016/S1474-4422(16)30357-X. Epub 2017 Feb 15.
PMID: 28229893DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Biogen Study Medical Director
- Organization
- Biogen
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2013
First Posted
October 7, 2013
Study Start
January 1, 2014
Primary Completion
February 1, 2015
Study Completion
April 1, 2015
Last Updated
July 1, 2016
Results First Posted
July 1, 2016
Record last verified: 2016-05