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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004783-11 | EudraCT Number |
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The primary objective of the study is to assess the clinical effects of natalizumab versus placebo in acute ischemic stroke on clinical measures of functional independence and activities of daily living. The secondary objective of the study is to explore dose and exposure response and the clinical treatment effects of natalizumab versus placebo in acute ischemic stroke on the following: measures of independence, activities of daily living, neurologic function, quality of life, cognition, and safety and tolerability
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| natalizumab high dose | Experimental | 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 low dose | Experimental | 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. |
|
| Placebo | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| natalizumab | Drug | Administered as specified in the treatment arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Composite Global Measure of Functional Disability Excellent Outcome at Day 90 | The composite global measure of functional disability excellent outcome was based on a score of 0 or 1 on the modified Rankin Scale (mRS) and a score of >=95 on the Barthel Index (BI). mRS measures independence, rather than neurological function, with specific tasks pre- and post-stroke. The scale consists of 7 grades, from 0 to 6, with 0 corresponding to no symptoms and 6 corresponding to death. BI consists of 10 items that measure a participant's daily functioning, specifically the activities of daily living and mobility. The items include feeding, moving from wheelchair to bed and returning, grooming, transferring to and from a toilet, bathing, walking on a level surface, going up and down stairs, dressing, and maintaining continence of bowels and bladder. The scores for each of the items are summed to create a total score of 0 to 100. The higher the score, the more "independent" the participant is. | Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Excellent Outcome in mRS Score at Day 90 | Excellent mRS is defined as mRS score of 0 or 1. mRS measures independence, rather than neurological function, with specific tasks pre- and poststroke. The scale consists of 7 grades, from 0 to 6, with 0 corresponding to no symptoms and 6 corresponding to death. | Day 90 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Los Angeles | California | 90024 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32591475 | Derived | 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. |
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A total of 277 participants with acute ischemic stroke were randomized into the study (94 participants in the placebo group, 91 participants in the natalizumab 300 milligram (mg) group, and 92 participants in the natalizumab 600 mg group).
Participants were recruited from 19 sites in Germany, 4 sites in the United Kingdom (UK), 12 sites in Spain, and 18 sites in the United States (US).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Single dose of matching placebo intravenous (IV) to natalizumab on Day 1 at one of two treatment windows, either within 9 hours or between 9-24 hours from when the participant was last known normal (LKN). |
| FG001 | Natalizumab 300 mg IV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 19, 2017 | Dec 18, 2018 |
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| Placebo | Drug | Matched placebo |
|
| Percentage of Participants With Excellent Outcome in BI Score at Day 90 | Excellent BI outcome is defined as a score of >=95. BI consists of 10 items that measure a participant's daily functioning, specifically the activities of daily living and mobility. The items include feeding, moving from wheelchair to bed and returning, grooming, transferring to and from a toilet, bathing, walking on a level surface, going up and down stairs, dressing, and maintaining continence of bowels and bladder. The scores for each of the items are summed to create a total score of 0 to 100. The higher the score, the more "independent" the participant is. | Day 90 |
| Stroke Impact Scale-16 (SIS-16) Score Using a Repeated Measures Mixed Effects Model at Day 90 | The SIS-16 is a 16-item physical dimension instrument that was developed as a brief, stand-alone tool for measuring the physical aspects of stroke recovery. The 16 physical aspects are rated on a 1 to 5 scale as follows: not difficult at all (5), a little difficult (4), somewhat difficult (3), very difficult (2), and could not do at all (1). Total score range is 16 to 80, with higher scores indicating higher levels of health-related quality of life and function. | Day 90 |
| Montreal Cognitive Assessment (MoCA) Score at Day 90 | The MoCA is a global cognitive screening test with favorable psychometric properties It screens 8 domains: visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall, and orientation. Time to administer the MoCA is approximately 10 minutes. The total possible score is 0 to 30 points; a score of 26 or above is considered normal, <10 (severe cognitive impairment), 10-17 (moderate cognitive impairment) and >=18 (mild cognitive impairment). | Day 90 |
| Change From Baseline in National Institute of Health Stroke Scale (NIHSS) Score at Day 90 | The NIHSS is a reliable tool for rapidly evaluating the effects of acute cerebral infarction. A trained observer rates the participant's ability to answer questions and perform activities relating to level of consciousness, language, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, sensory loss, and extinction and inattention (formerly neglect). There are 15 items. Total score ranges from 0 as normal to a maximum possible total severity score of 42 for all items. Higher the score, more the severity. A negative change from Baseline indicates improvement. | Baseline, Day 90 |
| Number of Participants Experiencing Adverse Events (AE) | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | Baseline up to Day 90 |
| Number of Participants Experiencing Serious Adverse Events (SAE) | A SAE is any untoward medical occurrence that at any dose results in death, is a life-threatening event, requires inpatient hospitalization, results in a significant disability/incapacity or congenital anomaly. | Baseline up to Day 90 |
| Percentage of Participants With Dose Response at Day 90 | Percentage of participants with dose response was evaluated in proportion of excellent outcome on mRS and BI. | Day 90 |
| Sacramento |
| California |
| 95816 |
| United States |
| Research Site | San Diego | California | 92103 | United States |
| Research Site | Washington D.C. | District of Columbia | 20007 | United States |
| Research Site | Gainesville | Florida | 32611 | United States |
| Research Site | Fort Wayne | Indiana | 46845 | United States |
| Research Site | Boston | Massachusetts | 02114 | United States |
| Research Site | St Louis | Missouri | 63110 | United States |
| Research Site | New York | New York | 10032 | United States |
| Research Site | Durham | North Carolina | 19104 | United States |
| Research Site | Columbus | Ohio | 43210 | United States |
| Research Site | Portland | Oregon | 97201 | United States |
| Research Site | Portland | Oregon | 97225 | United States |
| Research Site | Portland | Oregon | 97239 | United States |
| Research Site | Abington | Pennsylvania | 19001 | United States |
| Research Site | Philadelphia | Pennsylvania | 19104 | United States |
| Research Site | Charleston | South Carolina | 29425 | United States |
| Research Site | Knoxville | Tennessee | 37920-6999 | United States |
| Research Site | Altenburg | 04600 | Germany |
| Research Site | Bad Neustadt/Saale | 97616 | Germany |
| Research Site | Bamberg | 96049 | Germany |
| Research Site | Bergisch Gladbach | 51465 | Germany |
| Research Site | Dresden | 01067 | Germany |
| Research Site | Dresden | 01307 | Germany |
| Research Site | Düsseldorf | 40225 | Germany |
| Research Site | Erlangen | 91054 | Germany |
| Research Site | Frankfurt | 60528 | Germany |
| Research Site | Hamburg | 20246 | Germany |
| Research Site | Heidelberg | 69120 | Germany |
| Research Site | Leipzig | 04103 | Germany |
| Research Site | Ludwigshafen | 67063 | Germany |
| Research Site | Mannheim | 68167 | Germany |
| Research Site | Minden | 32429 | Germany |
| Research Site | Münster | 48149 | Germany |
| Research Site | Trier | 54292 | Germany |
| Research Site | Tübingen | 72076 | Germany |
| Research Site | Ulm | 89081 | Germany |
| Research Site | Albacete | 02008 | Spain |
| Research Site | Badalona | 08916 | Spain |
| Research Site | Barcelona | 08003 | Spain |
| Research Site | Barcelona | 08035 | Spain |
| Research Site | Girona | 17007 | Spain |
| Research Site | Lugo | 27003 | Spain |
| Research Site | Madrid | 28007 | Spain |
| Research Site | Madrid | 28034 | Spain |
| Research Site | Málaga | 29010 | Spain |
| Research Site | Seville | 41013 | Spain |
| Research Site | Seville | 41017 | Spain |
| Research Site | Valladolid | 47005 | Spain |
| Research Site | London | Greater London | SW17 0QT | United Kingdom |
| Research Site | London | Greater London | W6 8RF | United Kingdom |
| Research Site | Harrow | Middlesex | HA1 3UJ | United Kingdom |
| Research Site | Stoke-on-Trent | Staffordshire | ST4 6QG | United Kingdom |
Single 300 mg natalizumab IV on Day 1 at one of two treatment windows, either within 9 hours or between 9-24 hours from when the participant was last known normal (LKN). |
| FG002 | Natalizumab 600 mg IV | Single 600 mg natalizumab IV on Day 1 at one of two treatment windows, either within 9 hours or between 9-24 hours from when the participant was last known normal (LKN). |
| Safety Population | Participants who had received any study treatment (including complete or incomplete infusion) |
|
| Participants Dosed |
|
| Who Received Total Volume of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat (ITT) population included all participants who were randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Single dose of matching placebo intravenous (IV) to natalizumab on Day 1 at one of two treatment windows, either within 9 hours or between 9-24 hours from when the participant was last known normal (LKN). |
| BG001 | Natalizumab 300 mg IV | Single 300 mg natalizumab IV on Day 1 at one of two treatment windows, either within 9 hours or between 9-24 hours from when the participant was last known normal (LKN). |
| BG002 | Natalizumab 600 mg IV | Single 600 mg natalizumab IV on Day 1 at one of two treatment windows, either within 9 hours or between 9-24 hours from when the participant was last known normal (LKN). |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | count of participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Composite Global Measure of Functional Disability Excellent Outcome at Day 90 | The composite global measure of functional disability excellent outcome was based on a score of 0 or 1 on the modified Rankin Scale (mRS) and a score of >=95 on the Barthel Index (BI). mRS measures independence, rather than neurological function, with specific tasks pre- and post-stroke. The scale consists of 7 grades, from 0 to 6, with 0 corresponding to no symptoms and 6 corresponding to death. BI consists of 10 items that measure a participant's daily functioning, specifically the activities of daily living and mobility. The items include feeding, moving from wheelchair to bed and returning, grooming, transferring to and from a toilet, bathing, walking on a level surface, going up and down stairs, dressing, and maintaining continence of bowels and bladder. The scores for each of the items are summed to create a total score of 0 to 100. The higher the score, the more "independent" the participant is. | Modified Intent-to-Treat (MITT) population: all randomized participants who had received entire infusion of study treatment. Participants who were accidentally enrolled based on conditions that mimicked stroke symptom at presentation were excluded from MITT population. Number analyzed is the number of participants with data available for analysis. | Posted | Number | percentage of participants | Day 90 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Excellent Outcome in mRS Score at Day 90 | Excellent mRS is defined as mRS score of 0 or 1. mRS measures independence, rather than neurological function, with specific tasks pre- and poststroke. The scale consists of 7 grades, from 0 to 6, with 0 corresponding to no symptoms and 6 corresponding to death. | MITT population: all randomized participants who had received entire infusion of study treatment. Participants who were accidentally enrolled based on conditions that mimicked stroke symptom at presentation were excluded from MITT population. Number analyzed is number of participants with data available for analysis. | Posted | Number | percentage of participants | Day 90 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Excellent Outcome in BI Score at Day 90 | Excellent BI outcome is defined as a score of >=95. BI consists of 10 items that measure a participant's daily functioning, specifically the activities of daily living and mobility. The items include feeding, moving from wheelchair to bed and returning, grooming, transferring to and from a toilet, bathing, walking on a level surface, going up and down stairs, dressing, and maintaining continence of bowels and bladder. The scores for each of the items are summed to create a total score of 0 to 100. The higher the score, the more "independent" the participant is. | MITT population: all randomized participants who had received entire infusion of study treatment. Participants who were accidentally enrolled based on conditions that mimicked stroke symptom at presentation were excluded from MITT population. Number analyzed is number of participants with data available for analysis. | Posted | Number | percentage of participants | Day 90 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Stroke Impact Scale-16 (SIS-16) Score Using a Repeated Measures Mixed Effects Model at Day 90 | The SIS-16 is a 16-item physical dimension instrument that was developed as a brief, stand-alone tool for measuring the physical aspects of stroke recovery. The 16 physical aspects are rated on a 1 to 5 scale as follows: not difficult at all (5), a little difficult (4), somewhat difficult (3), very difficult (2), and could not do at all (1). Total score range is 16 to 80, with higher scores indicating higher levels of health-related quality of life and function. | MITT population: all randomized participants who had received entire infusion of study treatment. Participants who were accidentally enrolled based on conditions that mimicked stroke symptom at presentation were excluded from MITT population. Number analyzed is number of participants with data available for analysis. | Posted | Mean | Standard Deviation | score on a scale | Day 90 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Montreal Cognitive Assessment (MoCA) Score at Day 90 | The MoCA is a global cognitive screening test with favorable psychometric properties It screens 8 domains: visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall, and orientation. Time to administer the MoCA is approximately 10 minutes. The total possible score is 0 to 30 points; a score of 26 or above is considered normal, <10 (severe cognitive impairment), 10-17 (moderate cognitive impairment) and >=18 (mild cognitive impairment). | MITT population: all randomized participants who had received entire infusion of study treatment. Participants who were accidentally enrolled based on conditions that mimicked stroke symptom at presentation were excluded from MITT population. Number analyzed is number of participants with data available for analysis. | Posted | Mean | Standard Deviation | score on a scale | Day 90 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in National Institute of Health Stroke Scale (NIHSS) Score at Day 90 | The NIHSS is a reliable tool for rapidly evaluating the effects of acute cerebral infarction. A trained observer rates the participant's ability to answer questions and perform activities relating to level of consciousness, language, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, sensory loss, and extinction and inattention (formerly neglect). There are 15 items. Total score ranges from 0 as normal to a maximum possible total severity score of 42 for all items. Higher the score, more the severity. A negative change from Baseline indicates improvement. | MITT population: all randomized participants who had received entire infusion of study treatment. Participants who were accidentally enrolled based on conditions that mimicked stroke symptom at presentation were excluded from MITT population. Number analyzed is number of participants with data available for analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 90 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Experiencing Adverse Events (AE) | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | The safety population was defined as participants who had received any study treatment, including cases of complete or incomplete infusion. | Posted | Number | participants | Baseline up to Day 90 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Experiencing Serious Adverse Events (SAE) | A SAE is any untoward medical occurrence that at any dose results in death, is a life-threatening event, requires inpatient hospitalization, results in a significant disability/incapacity or congenital anomaly. | The safety population was defined as participants who had received any study treatment, including cases of complete or incomplete infusion. | Posted | Number | participants | Baseline up to Day 90 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Dose Response at Day 90 | Percentage of participants with dose response was evaluated in proportion of excellent outcome on mRS and BI. | MITT population: all randomized participants who had received entire infusion of study treatment. Participants who were accidentally enrolled based on conditions that mimicked stroke symptom at presentation were excluded from MITT population. Number analyzed is number of participants with data available for analysis. | Posted | Number | percentage of participants | Day 90 |
|
Baseline up to Day 90
The safety population was defined as participants who had received any study treatment, including cases of complete or incomplete infusion.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Single dose of matching placebo intravenous (IV) to natalizumab on Day 1 at one of two treatment windows, either within 9 hours or between 9-24 hours from when the participant was last known normal (LKN). | 5 | 91 | 19 | 91 | 67 | 91 |
| EG001 | Natalizumab 300 mg IV | Single 300 mg natalizumab IV on Day 1 at one of two treatment windows, either within 9 hours or between 9-24 hours from when the participant was last known normal (LKN). | 6 | 90 | 23 | 90 | 69 | 90 |
| EG002 | Natalizumab 600 mg IV | Single 600 mg natalizumab IV on Day 1 at one of two treatment windows, either within 9 hours or between 9-24 hours from when the participant was last known normal (LKN). | 4 | 89 | 29 | 89 | 65 | 89 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Sinus node dysfunction | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Oesophageal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Ischaemic hepatitis | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Endocarditis bacterial | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Enterococcal sepsis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Haemophilus infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumonia acinetobacter | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Septic encephalopathy | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Splenic abscess | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Wound infection staphylococcal | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Aortic restenosis | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Brain herniation | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Ilium fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Periprocedural myocardial infarction | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Escherichia test positive | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hyperglycaemic hyperosmolar nonketotic syndrome | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pancreatic carcinoma stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cerebral artery occlusion | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cerebral reperfusion injury | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cytotoxic oedema | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Embolic cerebral infarction | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Haemorrhagic transformation stroke | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Neurological decompensation | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Stroke in evolution | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Ureteric rupture | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Idiopathic angioedema | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Aortic embolus | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Peripheral artery occlusion | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Haemorrhagic transformation stroke | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Biogen Study Medical Director | Biogen | 866-633-4636 | clinicaltrials@biogen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 5, 2017 | Dec 18, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069442 | Natalizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| White |
|
| Not Reported Due to Confidentiality Regulations |
|
| Missing |
|
| Composite Measure: The global odds ratio was based on a linear logistic regression model with baseline NIHSS category (score 5-15, 16-23), age (<60, 60-69, 70-80), tPA use (yes/no), treatment window (<=9, >9 and <=24hours), thrombectomy (yes/no) and region (Spain, UK/Germany, USA) as covariates and unstructured working correlation structure | Regression, Logistic | 0.031 | Odds Ratio (OR) | 0.57 | 2-Sided | 95 | 0.34 | 0.95 | Superiority |
|
|
|
| OG002 | Natalizumab 600 mg IV | Single 600 mg natalizumab IV on Day 1 at one of two treatment windows, either within 9 hours or between 9-24 hours from when the participant was last known normal (LKN). |
|
|
|
| OG002 |
| Natalizumab 600 mg IV |
Single 600 mg natalizumab IV on Day 1 at one of two treatment windows, either within 9 hours or between 9-24 hours from when the participant was last known normal (LKN). |
|
|
|
| Natalizumab 600 mg IV |
Single 600 mg natalizumab IV on Day 1 at one of two treatment windows, either within 9 hours or between 9-24 hours from when the participant was last known normal (LKN). |
|
|
|
| OG002 | Natalizumab 600 mg IV | Single 600 mg natalizumab IV on Day 1 at one of two treatment windows, either within 9 hours or between 9-24 hours from when the participant was last known normal (LKN). |
|
|
|
Single 600 mg natalizumab IV on Day 1 at one of two treatment windows, either within 9 hours or between 9-24 hours from when the participant was last known normal (LKN).
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|