Safety and Efficacy of Intravenous Natalizumab in Acute Ischemic Stroke
NCT ID: NCT02730455
Last Updated: 2019-01-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
277 participants
INTERVENTIONAL
2016-07-18
2017-11-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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natalizumab high dose
Single IV (intravenous) dose natalizumab at baseline at one of two treatment windows, either within 9 hours of last known normal (LKN) or between 9-24 hours after LKN.
natalizumab
Administered as specified in the treatment arm
natalizumab low dose
Single IV (intravenous) dose natalizumab at baseline at one of two treatment windows, either within 9 hours of last known normal (LKN) or between 9-24 hours after LKN.
natalizumab
Administered as specified in the treatment arm
Placebo
Single dose of Placebo IV at baseline at one of two treatment windows, either within 9 hours of last known normal (LKN) or between 9-24 hours after LKN.
Placebo
Matched placebo
Interventions
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natalizumab
Administered as specified in the treatment arm
Placebo
Matched placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Score of 5 to 23 points, inclusive, on the NIHSS at Screening for subjects initiating treatment ≤9 hours from LKN. Note: NIHSS eligibility must be confirmed within 60 minutes prior to randomization.
* Score of 5 to 15 points, inclusive, on the NIHSS at Screening for subjects initiating treatment \>9 to ≤24 hours from LKN. Note: NIHSS eligibility must be confirmed within 60 minutes prior to randomization.
* Prior to index stroke, patient was able to perform basic activities of daily living without assistance: dressing, eating, walking, bathing, and using the toilet.
* For those subjects who underwent a cranial MRI, there is at least 1 acute infarct with a diameter of ≥2 cm on baseline brain diffusion-weighted imaging.
Exclusion Criteria
* Presence of acute intracranial hemorrhage on acute brain CT or MRI. However, petechial hemorrhages of ≤1 cm are not exclusionary.
* Severe stroke defined by imaging criteria based on either one of the following:
* Alberta Stroke Program Early CT (ASPECT) score of 0 to 4 based on head CT or
* Acute infarct volume on MRI diffusion weighed imaging greater than or equal to 70 mL
* Seizure at the onset of stroke.
* Known history of prior treatment with natalizumab.
* Known history of active viral hepatitis B or C.
* Signs and symptoms of active or acute infection.
18 Years
80 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
Los Angeles, California, United States
Research Site
Sacramento, California, United States
Research Site
San Diego, California, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Gainesville, Florida, United States
Research Site
Fort Wayne, Indiana, United States
Research Site
Boston, Massachusetts, United States
Research Site
St Louis, Missouri, United States
Research Site
New York, New York, United States
Research Site
Durham, North Carolina, United States
Research Site
Columbus, Ohio, United States
Research Site
Portland, Oregon, United States
Research Site
Portland, Oregon, United States
Research Site
Portland, Oregon, United States
Research Site
Abington, Pennsylvania, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Charleston, South Carolina, United States
Research Site
Knoxville, Tennessee, United States
Research Site
Altenburg, , Germany
Research Site
Bad Neustadt/Saale, , Germany
Research Site
Bamberg, , Germany
Research Site
Bergisch Gladbach, , Germany
Research Site
Dresden, , Germany
Research Site
Dresden, , Germany
Research Site
Düsseldorf, , Germany
Research Site
Erlangen, , Germany
Research Site
Frankfurt, , Germany
Research Site
Hamburg, , Germany
Research Site
Heidelberg, , Germany
Research Site
Leipzig, , Germany
Research Site
Ludwigshafen, , Germany
Research Site
Mannheim, , Germany
Research Site
Minden, , Germany
Research Site
Münster, , Germany
Research Site
Trier, , Germany
Research Site
Tübingen, , Germany
Research Site
Ulm, , Germany
Research Site
Albacete, , Spain
Research Site
Badalona, , Spain
Research Site
Barcelona, , Spain
Research Site
Barcelona, , Spain
Research Site
Girona, , Spain
Research Site
Lugo, , Spain
Research Site
Madrid, , Spain
Research Site
Madrid, , Spain
Research Site
Málaga, , Spain
Research Site
Seville, , Spain
Research Site
Seville, , Spain
Research Site
Valladolid, , Spain
Research Site
London, Greater London, United Kingdom
Research Site
London, Greater London, United Kingdom
Research Site
Harrow, Middlesex, United Kingdom
Research Site
Stoke-on-Trent, Staffordshire, United Kingdom
Countries
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References
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Elkind MSV, Veltkamp R, Montaner J, Johnston SC, Singhal AB, Becker K, Lansberg MG, Tang W, Kasliwal R, Elkins J. Natalizumab in acute ischemic stroke (ACTION II): A randomized, placebo-controlled trial. Neurology. 2020 Aug 25;95(8):e1091-e1104. doi: 10.1212/WNL.0000000000010038. Epub 2020 Jun 26.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-004783-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
101SK202
Identifier Type: -
Identifier Source: org_study_id
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