Safety and Efficacy of Intravenous Natalizumab in Acute Ischemic Stroke "ACTION2"

Active, not recruiting

Phase 2 Results N/A

Update History

18 Oct '17
A location was updated in Phoenix.
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The overall status was removed for Research Site.
A location was updated in La Jolla.
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The overall status was removed for Research Site.
A location was updated in Los Angeles.
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The overall status was removed for Research Site.
A location was updated in Sacramento.
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The overall status was removed for Research Site.
A location was updated in San Diego.
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The overall status was removed for Research Site.
A location was updated in Washington, D.C..
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The overall status was removed for Research Site.
A location was updated in Gainesville.
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The overall status was removed for Research Site.
A location was updated in Fort Wayne.
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The overall status was removed for Research Site.
A location was updated in Kansas City.
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The overall status was removed for Research Site.
A location was updated in Boston.
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The overall status was removed for Research Site.
A location was updated in Robbinsdale.
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The overall status was removed for Research Site.
A location was updated in Saint Louis.
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The overall status was removed for Research Site.
A location was updated in New York.
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The overall status was removed for Research Site.
A location was updated in Durham.
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The overall status was removed for Research Site.
A location was updated in Akron.
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The overall status was removed for Research Site.
A location was updated in Cleveland.
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The overall status was removed for Research Site.
A location was updated in Columbus.
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The overall status was removed for Research Site.
A location was updated in Dayton.
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The overall status was removed for Research Site.
A location was updated in Portland.
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The overall status was removed for Research Site.
A location was updated in Portland.
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The overall status was removed for Research Site.
A location was updated in Portland.
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The overall status was removed for Research Site.
A location was updated in Abington.
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The overall status was removed for Research Site.
A location was updated in Philadelphia.
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The overall status was removed for Research Site.
A location was updated in Charleston.
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The overall status was removed for Research Site.
A location was updated in Knoxville.
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The overall status was removed for Research Site.
A location was updated in Seattle.
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The overall status was removed for Research Site.
A location was updated in Altenburg.
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The overall status was removed for Research Site.
A location was updated in Bad Neustadt/Saale.
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The overall status was removed for Research Site.
A location was updated in Bamberg.
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The overall status was removed for Research Site.
A location was updated in Bayreuth.
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The overall status was removed for Research Site.
A location was updated in Bergisch Gladbach.
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The overall status was removed for Research Site.
A location was updated in Berlin.
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The overall status was removed for Research Site.
A location was updated in Dresden.
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The overall status was removed for Research Site.
A location was updated in Dresden.
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The overall status was removed for Research Site.
A location was updated in Duesseldorf.
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The overall status was removed for Research Site.
A location was updated in Erlangen.
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The overall status was removed for Research Site.
A location was updated in Frankfurt.
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The overall status was removed for Research Site.
A location was updated in Hamburg.
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The overall status was removed for Research Site.
A location was updated in Heidelberg.
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The overall status was removed for Research Site.
A location was updated in Leipzig.
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The overall status was removed for Research Site.
A location was updated in Ludwigshafen.
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The overall status was removed for Research Site.
A location was updated in Mannheim.
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The overall status was removed for Research Site.
A location was updated in Minden.
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The overall status was removed for Research Site.
A location was updated in Muenster.
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The overall status was removed for Research Site.
A location was updated in Trier.
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The overall status was removed for Research Site.
A location was updated in Tuebingen.
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The overall status was removed for Research Site.
A location was updated in Ulm.
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The overall status was removed for Research Site.
A location was updated in A Coruña.
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The overall status was removed for Research Site.
A location was updated in Albacete.
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The overall status was removed for Research Site.
A location was updated in Badalona.
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The overall status was removed for Research Site.
A location was updated in Barakaldo.
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The overall status was removed for Research Site.
A location was updated in Barcelona.
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The overall status was removed for Research Site.
A location was updated in Barcelona.
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The overall status was removed for Research Site.
A location was updated in Girona.
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The overall status was removed for Research Site.
A location was updated in Lugo.
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The overall status was removed for Research Site.
A location was updated in Madrid.
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The overall status was removed for Research Site.
A location was updated in Madrid.
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The overall status was removed for Research Site.
A location was updated in Madrid.
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The overall status was removed for Research Site.
A location was updated in Malaga.
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The overall status was removed for Research Site.
A location was updated in Sevilla.
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The overall status was removed for Research Site.
A location was updated in Valladolid.
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The overall status was removed for Research Site.
A location was updated in London.
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The overall status was removed for Research Site.
A location was updated in London.
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The overall status was removed for Research Site.
A location was updated in London.
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The overall status was removed for Research Site.
A location was updated in Harrow.
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The overall status was removed for Research Site.
A location was updated in Stoke on Trent.
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The overall status was removed for Research Site.
A location was updated in Romford.
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The overall status was removed for Research Site.
8 Sep '17
The eligibility criteria were updated.
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Key Inclusion Criteria: - Clinical diagnosis of supratentorial acute ischemic stroke defined by LKN ≤24 hours prior to study treatment initiation. - 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. Key Exclusion Criteria: - Lacunar or isolated brainstem or cerebellar stroke based on clinical assessment and available acute imaging studies performed under the standard of care. - 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. NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
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Key Inclusion Criteria: - Clinical diagnosis of supratentorial acute ischemic stroke defined by LKN ≤24 hours prior to study treatment initiation. - 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. Key Exclusion Criteria: - Lacunar or isolated brainstem or cerebellar stroke based on clinical assessment and available acute imaging studies performed under the standard of care. - Presence of acute intracranial hemorrhage on acute brain CT or MRI. However, petechial hemorrhages of ≤1 cm are not exclusionary. - Severe stroke. - 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. NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
5 May '17
A location was updated in Bamberg.
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The overall status was removed for Research Site.
14 Apr '17
Trial acronym was updated.
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ACTION2
The gender criteria for eligibility was updated to "All."
The eligibility criteria were updated.
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Key Inclusion Criteria: - Clinical diagnosis of supratentorial acute ischemic stroke defined by LKN ≤24 hours prior to study treatment initiation. - 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. Key Exclusion Criteria: - Lacunar or isolated brainstem or cerebellar stroke based on clinical assessment and available acute imaging studies performed under the standard of care. - Presence of acute intracranial hemorrhage on acute brain CT or MRI. However, petechial hemorrhages of ≤1 cm are not exclusionary. - Severe stroke. - 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. NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Old
Key Inclusion Criteria: - Clinical diagnosis of supratentorial acute ischemic stroke defined by LKN ≤9 hours prior to study treatment initiation - Score of 5 to 23 points, inclusive, on the NIHSS at Screening - Prior to index stroke, patient was able to perform basic activities of daily living without assistance - 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 Key Exclusion Criteria: - Rapidly improving or minor stroke symptoms - Lacunar or isolated brainstem stroke based on clinical assessment and available acute imaging studies - Presence of acute intracranial hemorrhage on acute brain CT or MRI - Severe stroke NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
A location was updated in Charleston.
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The overall status was removed for Research Site.
A location was updated in Harrow.
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The overall status was removed for Research Site.
18 Oct '16
A location was updated in Phoenix.
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The overall status was removed for Research Site.
A location was updated in Los Angeles.
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The overall status was removed for Research Site.
A location was updated in Sacramento.
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The overall status was removed for Research Site.
A location was updated in San Diego.
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The overall status was removed for Research Site.
A location was updated in Kansas City.
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The overall status was removed for Research Site.
A location was updated in Akron.
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The overall status was removed for Research Site.
A location was updated in Philadelphia.
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The overall status was removed for Research Site.
A location was updated in Mannheim.
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The overall status was updated to "Recruiting" at Research Site.
A location was updated in Barcelona.
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The overall status was updated to "Not yet recruiting" at Research Site.
A location was updated in Barcelona.
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The overall status was updated to "Not yet recruiting" at Research Site.
A location was updated in Lugo.
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The overall status was updated to "Recruiting" at Research Site.
A location was updated in Madrid.
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The overall status was updated to "Not yet recruiting" at Research Site.
A location was updated in Madrid.
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The overall status was updated to "Not yet recruiting" at Research Site.
A location was updated in Valladolid.
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The overall status was updated to "Recruiting" at Research Site.
A location was updated in London.
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The overall status was removed for Research Site.
A location was updated in London.
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The overall status was removed for Research Site.
20 Aug '16
A location was updated in Washington.
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The overall status was updated to "Recruiting" at Research Site.
A location was updated in Fort Wayne.
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The overall status was removed for Research Site.
A location was updated in Boston.
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The overall status was removed for Research Site.
A location was updated in St. Louis.
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The overall status was updated to "Recruiting" at Research Site.
A location was updated in Durham.
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The overall status was removed for Research Site.
A location was updated in Cleveland.
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The overall status was removed for Research Site.
A location was updated in Columbus.
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The overall status was removed for Research Site.
A location was updated in Dayton.
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The overall status was removed for Research Site.
A location was updated in Portland.
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The overall status was removed for Research Site.
A location was updated in Seattle.
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The overall status was removed for Research Site.
A location was updated in Badalona.
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The overall status was updated to "Recruiting" at Research Site.
A location was updated in Barcelona.
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The overall status was updated to "Not yet recruiting" at Research Site.
A location was updated in Barcelona.
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The overall status was updated to "Not yet recruiting" at Research Site.
A location was updated in Girona.
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The overall status was updated to "Recruiting" at Research Site.
28 Jul '16
A location was updated in Robbinsdale.
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The overall status was removed for Research Site.
A location was updated in Portland.
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The overall status was removed for Research Site.
A location was updated in Barcelona.
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The overall status was updated to "Not yet recruiting" at Research Site.
A location was updated in Barcelona.
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The overall status was updated to "Not yet recruiting" at Research Site.
A location was updated in Sevilla.
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The overall status was updated to "Recruiting" at Research Site.
12 Jul '16
A location was updated in New York.
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The overall status was removed for Research Site.
A location was updated in Portland.
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The overall status was removed for Research Site.
A location was updated in Barcelona.
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The overall status was updated to "Not yet recruiting" at Research Site.
A location was updated in Barcelona.
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The overall status was updated to "Not yet recruiting" at Research Site.
A location was updated in Málaga.
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The overall status was updated to "Recruiting" at Research Site.
A location was updated in Sevilla.
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The overall status was updated to "Recruiting" at Research Site.
A location was updated in Sevilla.
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The overall status was updated to "Recruiting" at Research Site.
17 Jun '16
Trial acronym was updated.
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ACTION 2
A location was updated in Barcelona.
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The overall status was updated to "Not yet recruiting" at Research Site.