Effect of Natalizumab on Infarct Volume in Acute Ischemic Stroke "ACTION"

Completed

Phase 2 Results

Update History

5 Jul '16
The Summary of Purpose was updated.
New
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.
Old
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.
30 Apr '15
The Summary of Purpose was updated.
New
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.
Old
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
10 Feb '15
The Summary of Purpose was updated.
New
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
Old
The primary objective of the study is to determine whether one 300 mg dose of intravenous (IV) BG00002 reduces change in infarct volume from Baseline to Day 5 on magnetic resonance imaging (MRI) in subjects 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 BG00002 on change in infarct volume from Baseline to Day 30; To assess efficacy of BG00002 on change in infarct volume from 24 hours to Day 5 and Day 30; To assess the efficacy of BG00002 on clinical measures of stroke outcome; To assess the safety of BG00002 in subjects with acute ischemic stroke
A location was updated in San Diego.
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The overall status was removed for Sharp Memorial Hospital.
A location was updated in San Diego.
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The overall status was removed for University of California San Diego Medical Center.
A location was updated in Gainesville.
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The overall status was removed for University of Florida.
A location was updated in Kansas City.
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The overall status was removed for University of Kansas Medical Center Research Institute, Inc..
A location was updated in Boston.
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The overall status was removed for Massachusetts General Hospital.
A location was updated in Golden Valley.
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The overall status was removed for North Memorial Medical Center.
A location was updated in St. Louis.
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The overall status was removed for Washington University.
A location was updated in Bronx.
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The overall status was removed for Montefiore Medical Center PRIME.
A location was updated in New York.
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The overall status was removed for Columbia University Medical Center.
A location was updated in Durham.
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The overall status was removed for Duke University Medical Center.
A location was updated in Akron.
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The overall status was removed for Akron General Medical Center.
A location was updated in Cleveland.
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The overall status was removed for MetroHealth System.
A location was updated in Dayton.
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The overall status was removed for Miami Valley Hospital.
A location was updated in Toledo.
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The overall status was removed for University of Toledo.
A location was updated in Portland.
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The overall status was removed for Oregon Health and Science University.
A location was updated in Portland.
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The overall status was removed for Providence Portland Stroke Center.
A location was updated in Portland.
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The overall status was removed for Providence Portland Stroke Center.
A location was updated in Tualatin.
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The overall status was removed for Legacy Meridian Park Hospital.
A location was updated in Philadelphia.
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The overall status was removed for University of Pennsylvania Hospital.
A location was updated in Nashville.
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The overall status was removed for Vanderbilt University Medical Center.
A location was updated in Dallas.
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The overall status was removed for UT Southwestern Medical Center at Dallas.
A location was updated in Charlottesville.
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The overall status was removed for University of Virginia.
A location was updated in Seattle.
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The overall status was removed for University of Washington School of Medicine.
A location was updated in Milwaukee.
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The overall status was removed for Froedtert & Medical College Clinics.
A location was updated in Milwaukee.
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The overall status was removed for Wheaton Franciscan Healthcare.
A location was updated in Altenburg.
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The overall status was removed for Klinikum Altenburger Land GmbH.
A location was updated in Bad Neustadt.
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The overall status was removed for Neurologishce Klinik Bad Neustadt/Saale.
A location was updated in Berlin.
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The overall status was removed for Charite - Campus Benjamin Franklin.
A location was updated in Bonn.
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The overall status was removed for Universitaetsklinikum Bonn AoeR.
A location was updated in Duesseldorf.
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The overall status was removed for Universitaetsklinikum Duesseldorf AoeR.
A location was updated in Erlangen.
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The overall status was removed for Universitaetsklinikum Erlangen.
A location was updated in Frankfurt.
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The overall status was removed for Klinikum der Johann Wolfgang Goethe-Universitaet.
A location was updated in Frankfurt.
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The overall status was removed for Klinikum Frankfurt Hoechst GmbH.
A location was updated in Hannover.
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The overall status was removed for Medizinische Hochschule Hannover.
A location was updated in Heidelberg.
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The overall status was removed for Universitaetsklinikum Heidelberg.
A location was updated in Idar-Oberstein.
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The overall status was removed for Klinikum Idar-Oberstein GmbH.
A location was updated in Leipzig.
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The overall status was removed for Universitaetsklinikum Leipzig AoeR.
A location was updated in Ludwigshafen.
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The overall status was removed for Klinikum Ludwigshafen.
A location was updated in Mannheim.
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The overall status was removed for Klinikum Mannheim GmbH Universitaetsklinikum.
A location was updated in Trier.
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The overall status was removed for Krankenhaus der Barmherzigen Brueder.
A location was updated in Tübingen.
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The overall status was removed for Universitätsklinikum Tübingen.
A location was updated in Ulm.
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The overall status was removed for Universitaetsklinikum Ulm.
A location was updated in Albacete.
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The overall status was removed for Complejo Hospitalario Universitario de Albacete.
A location was updated in Badalona.
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The overall status was removed for Hospital Universitari Germans Trias i Pujol.
A location was updated in Barcelona.
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The overall status was removed for Hospital Clinic I Provincial de Barcelona.
A location was updated in Barcelona.
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The overall status was removed for Hospital del Mar.
A location was updated in Barcelona.
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The overall status was removed for Hospital Universitari Vall d'Hebron.
A location was updated in Girona.
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The overall status was removed for Hospital Universitari de Girona Dr Josep Trueta.
A location was updated in Madrid.
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The overall status was removed for Hospital Universitario Ramón y Cajal.
A location was updated in Pamplona.
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The overall status was removed for Complejo Hospitalario de Navarra.
A location was updated in Santiago de Compostela.
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The overall status was removed for Hospital Clinico Universitario de Santiago.
A location was updated in Sevilla.
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The overall status was removed for Hospital Universitario Virgen del Rocio.
A location was updated in Sevilla.
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The overall status was removed for Hospital Universitario Virgen Macarena.
A location was updated in Valencia.
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The overall status was removed for Hospital General Universitario de Valencia.
A location was updated in Valencia.
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The overall status was removed for Hospital Universitari i Politecnic La Fe.
A location was updated in Valladolid.
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The overall status was removed for Hospital Clínico Universitario de Valladolid.
24 Dec '14
A location was updated in Tualatin.
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The overall status was removed for Legacy Meridian Park Hospital.
A location was updated in Tübingen.
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The overall status was removed for Universitätsklinikum Tübingen.
18 Nov '14
A location was updated in Sevilla.
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The overall status was removed for Hospital Universitario Virgen Macarena.
29 Oct '14
A location was updated in Milwaukee.
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The overall status was removed for Froedtert & Medical College Clinics.
A location was updated in Nashville.
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The overall status was removed for Vanderbilt University Medical Center.
17 Oct '14
A location was updated in Tübingen.
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The overall status was removed for Universitätsklinikum Tübingen.
20 Aug '14
A location was updated in Berlin.
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The overall status was removed for Charite - Campus Benjamin Franklin.
6 Aug '14
A location was updated in St. Louis.
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The overall status was removed for Washington University.
A location was updated in New York.
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The overall status was removed for Columbia University Medical Center.
29 Jul '14
A location was updated in Kansas City.
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The overall status was removed for University of Kansas Medical Center Research Institute, Inc..
A location was updated in Golden Valley.
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The overall status was removed for North Memorial Medical Center.
A location was updated in Duesseldorf.
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The overall status was removed for Universitaetsklinikum Duesseldorf AoeR.
A location was updated in Valencia.
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The overall status was removed for Hospital General Universitario de Valencia.
25 Jun '14
A location was updated in San Diego.
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The overall status was removed for University of California San Diego Medical Center.
A location was updated in Bronx.
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The overall status was removed for Montefiore Medical Center PRIME.
A location was updated in New York.
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The overall status was removed for Columbia University Medical Center.
A location was updated in Dayton.
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The overall status was removed for Miami Valley Hospital.
A location was updated in Philadelphia.
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The overall status was removed for University of Pennsylvania Hospital.
A location was updated in Bad Neustadt.
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The overall status was removed for Neurologishce Klinik Bad Neustadt/Saale.
A location was updated in Idar-Oberstein.
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The overall status was removed for Klinikum Idar-Oberstein GmbH.
A location was updated in Barcelona.
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The overall status was removed for Hospital Clinic I Provincial de Barcelona.
A location was updated in Barcelona.
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The overall status was removed for Hospital Universitari Vall d'Hebron.
A location was updated in Sevilla.
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The overall status was removed for Hospital Universitario Virgen del Rocio.
12 Mar '14
The Summary of Purpose was updated.
New
The primary objective of the study is to determine whether one 300 mg dose of intravenous (IV) BG00002 reduces change in infarct volume from Baseline to Day 5 on magnetic resonance imaging (MRI) in subjects 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 BG00002 on change in infarct volume from Baseline to Day 30; To assess efficacy of BG00002 on change in infarct volume from 24 hours to Day 5 and Day 30; To assess the efficacy of BG00002 on clinical measures of stroke outcome; To assess the safety of BG00002 in subjects with acute ischemic stroke
Old
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 subjects 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 subjects with acute ischemic stroke
The eligibility criteria were updated.
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Key Inclusion Criteria: - 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. Key Exclusion Criteria: - 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. NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
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Inclusion Criteria: - 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. Exclusion Criteria: - 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. - Other criteria may apply.