Effect of Natalizumab on Infarct Volume in Acute Ischemic Stroke
NCT ID: NCT01955707
Last Updated: 2016-07-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
161 participants
INTERVENTIONAL
2014-01-31
2015-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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natalizumab
300 mg single intravenous (IV) injection
natalizumab
Administered as described in the treatment arm
Placebo
A single IV dose of placebo
Placebo
Matched placebo
Interventions
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natalizumab
Administered as described in the treatment arm
Placebo
Matched placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
85 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Research Site
San Diego, California, United States
Research Site
Gainesville, Florida, United States
Research Site
Kansas City, Kansas, United States
Research Site
Boston, Massachusetts, United States
Research Site
Golden Valley, Minnesota, United States
Research Site
St Louis, Missouri, United States
Research Site
Lake Success, New York, United States
Research Site
New York, New York, United States
Research Site
Durham, North Carolina, United States
Research Site
Akron, Ohio, United States
Research Site
Dayton, Ohio, United States
Research Site
Toledo, Ohio, United States
Research Site
Portland, Oregon, United States
Research Site
Tualatin, Oregon, United States
Research Site
Philadelphia, Pennsylvania, 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, , Germany
Research Site
Bad Neustadt an der Saale, , Germany
Research Site
Berlin, , Germany
Research Site
Bonn, , Germany
Research Site
Düsseldorf, , Germany
Research Site
Erlangen, , Germany
Research Site
Frankfurt, , Germany
Research Site
Hanover, , Germany
Research Site
Heidelberg, , Germany
Research Site
Idar-Oberstein, , Germany
Research Site
Leipzig, , Germany
Research Site
Ludwigshafen, , Germany
Research Site
Ludwigshafen, , Germany
Research Site
Mannheim, , Germany
Research Site
Trier, , Germany
Research Site
Tübingen, , Germany
Research Site
Ulm, , Germany
Research Site
Albacete, , Spain
Research Site
Badalona, , Spain
Research Site
Barakaldo, , Spain
Research Site
Barcelona, , Spain
Research Site
Barcelona, , Spain
Research Site
Barcelona, , Spain
Research Site
Girona, , Spain
Research Site
Madrid, , Spain
Research Site
Pamplona, , Spain
Research Site
Santiago de Compostela, , Spain
Research Site
Seville, , Spain
Research Site
Seville, , Spain
Research Site
Valencia, , Spain
Research Site
Valladolid, , Spain
Countries
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References
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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.
Other Identifiers
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EUDRA CT NO: 2013-001514-15
Identifier Type: -
Identifier Source: secondary_id
101SK201
Identifier Type: -
Identifier Source: org_study_id
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